Phase I Study of Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors

This is a Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the variables of ML NK cell source. ML NK cells from an autologous source will be used for Arm 1, and ML NK cells from an allogeneic source will be used for Arm 2. The investigators hypothesize that ML NK cells from either an autologous source or allogeneic source are safe and tolerable in subjects with advanced and/or metastatic melanoma.

开始日期2024-11-06

申办/合作机构

Washington University School of Medicine

[+2]

NCT06561386 / Recruiting临床3期

A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression of 1% to 49%

The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 1-49%

开始日期2024-10-07

申办/合作机构

Bristol Myers Squibb Co.

NCT06029270 / Recruiting临床2期IIT

A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.

开始日期2024-07-15

申办/合作机构

National Cancer Institute

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项与瑞拉利单抗相关的文献（医药）

2024-12-31·Oncoimmunology

A phase 2, multicenter, open-label study of anti-LAG-3 ieramilimab in combination with anti-PD-1 spartalizumab in patients with advanced solid malignancies

Article

作者: Lin, Chia-Chi ; Kyi, Chrisann ; Chiu, Joanne ; Askoxylakis, Vasileios ; Carvajal, Richard D ; Spratlin, Jennifer ; Chowdhury, Niladri Roy ; Gusenleitner, Daniel ; Garralda, Elena ; Maur, Michela ; Esaki, Taito ; Siu, Lillian L ; Sarantopoulos, John ; Rolland, Fréderic ; Cassier, Philippe A ; Zhang, Tian ; Soo, Ross A ; Schöffski, Patrick ; Ma, Brigette ; Martin, Miguel ; Deschler-Baier, Barbara ; Weickhardt, Andrew ; De Braud, Filippo ; Hui, Rina ; Akerley, Wallace ; Rispoli, Lawrence ; Hong, David S ; Samant, Tanay S ; Tan, Daniel Sw ; Kwak, Eunice L

Ieramilimab, a humanized anti-LAG-3 monoclonal antibody, was well tolerated in combination with the anti-PD-1 antibody spartalizumab in a phase 1 study. This phase 2 study aimed to further investigate the efficacy and safety of combination treatment in patients with selected advanced (locally advanced or metastatic) solid malignancies. Eligible patients with non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), mesothelioma, and triple-negative breast cancer (TNBC) were grouped depending on prior anti-PD-1/L1 therapy (anti-PD-1/L1 naive or anti-PD-1/L1 pretreated). Patients received ieramilimab (400 mg) followed by spartalizumab (300 mg) every 3 weeks. The primary endpoint was objective response rate (ORR), along with safety, pharmacokinetics, and biomarker assessments. Of 235 patients, 142 were naive to anti-PD-1/L1 and 93 were pretreated with anti-PD-1/L1 antibodies. Durable responses (>24 months) were seen across all indications for patients naive to anti-PD-1/L1 and in melanoma and RCC patients pretreated with anti-PD1/L1. The most frequent study drug-related AEs were pruritus (15.5%), fatigue (10.6%), and rash (10.6%) in patients naive to anti-PD-1/L1 and fatigue (18.3%), rash (14.0%), and nausea (10.8%) in anti-PD-1/L1 pretreated patients. Biomarker assessment indicated higher expression of T-cell-inflamed gene signature at baseline among responding patients. Response to treatment was durable (>24 months) in some patients across all enrolled indications, and safety findings were in accordance with previous and current studies exploring LAG-3/PD-1 blockade.

2024-12-01·INTERNATIONAL IMMUNOPHARMACOLOGY

A comprehensive review of immune checkpoint inhibitors for cancer treatment

Review

作者: Arafat Hossain, Md. ; Arafat Hossain, Md

Immunology-based therapies are emerging as an effective cancer treatment, using the body's immune system to target tumors. Immune checkpoints, which regulate immune responses to prevent tissue damage and autoimmunity, are often exploited by cancer cells to avoid destruction. The discovery of checkpoint proteins like PD-1/PD-L1 and CTLA-4 was pivotal in developing cancer immunotherapy. Immune checkpoint inhibitors (ICIs) have shown great success, with FDA-approved drugs like PD-1 inhibitors (Nivolumab, Pembrolizumab, Cemiplimab), PD-L1 inhibitors (Atezolizumab, Durvalumab, Avelumab), and CTLA-4 inhibitors (Ipilimumab, Tremelimumab), alongside LAG-3 inhibitor Relatlimab. Research continues on new checkpoints like TIM-3, VISTA, B7-H3, BTLA, and TIGIT. Biomarkers like PDL-1 expression, tumor mutation burden, interferon-γ presence, microbiome composition, and extracellular matrix characteristics play a crucial role in predicting responses to immunotherapy with checkpoint inhibitors. Despite their effectiveness, not all patients experience the same level of benefit, and organ-specific immune-related adverse events (irAEs) such as rash or itching, colitis, diarrhea, hyperthyroidism, and hypothyroidism may occur. Given the rapid advancements in this field and the variability in patient outcomes, there is an urgent need for a comprehensive review that consolidates the latest findings on immune checkpoint inhibitors, covering their clinical status, biomarkers, resistance mechanisms, strategies to overcome resistance, and associated adverse effects. This review aims to fill this gap by providing an analysis of the current clinical status of ICIs, emerging biomarkers, mechanisms of resistance, strategies to enhance therapeutic efficacy, and assessment of adverse effects. This review is crucial to furthering our understanding of ICIs and optimizing their application in cancer therapy.

2024-10-18·CLINICAL CANCER RESEARCH

First-In-Human Dose-Escalation Study of Fianlimab, an Anti-Lymphocyte Activation Gene-3 Antibody, with Cemiplimab in patients with advanced malignancies.

Article

作者: Lynce, Filipa ; Jankovic, Vladimir ; Lakhani, Nehal J ; Gullo, Giuseppe ; Maki, Robert G ; Mani, Jayakumar ; Lowy, Israel ; Yap, Timothy A ; Paccaly, Anne ; Wang, Ding ; Gonzalez Ortiz, Ana ; Papadopoulos, Kyriakos P ; Kroog, Glenn ; Dowlati, Afshin ; Chen, Shuquan ; Ulahannan, Susanna ; Kelly, Karen ; Masinde, Sheila ; Sims, Tasha ; Johnson, Melissa Lynne ; Park, Haeseong ; Malhotra, Jyoti ; Williamson, Stephen

PURPOSE:

Preclinical data indicate that fianlimab (anti-lymphocyte activation gene-3) plus cemiplimab (anti-programmed cell death-1) enhances antitumor activity. Here, we report prespecified final analyses of the dose-escalation part of a first-in-human, phase 1 study (NCT03005782) of fianlimab as monotherapy and in combination with cemiplimab in patients with advanced malignancies.

EXPERIMENTAL DESIGN:

Adult patients received fianlimab 1-40 mg/kg ± cemiplimab 350 mg every 3 weeks (Q3W) across various dose-escalation schedules. Primary objectives were rate of dose-limiting toxicities, adverse events (including immune-mediated), deaths, laboratory abnormalities, and pharmacokinetics. Secondary outcomes were objective response rate, best overall response, duration of response, and antidrug antibody variables.

RESULTS:

Seventy-eight patients were enrolled (fianlimab + cemiplimab, n = 47; fianlimab monotherapy, n = 31). One patient treated with 3 mg/kg fianlimab + cemiplimab experienced dose-limiting toxicities, including increased blood creatine phosphokinase and myasthenic syndrome. No maximum tolerated dose was reached. Any-grade treatment-emergent adverse events occurred in 90% of patients with fianlimab monotherapy, 87% with fianlimab + cemiplimab, and 87% who transitioned from monotherapy to combination therapy. Fianlimab pharmacokinetics were dose-proportional, and similar in monotherapy and combination therapy. Across patients who received fianlimab + cemiplimab, five achieved a partial response; three of whom experienced a response after transitioning from monotherapy to combination therapy. Fianlimab 1600 mg Q3W (20 mg/kg in an 80 kg individual) is the selected dose for phase 2 and 3 studies.

CONCLUSIONS:

Fianlimab as monotherapy and in combination with cemiplimab demonstrated acceptable safety and preliminary antitumor activity, which is generally consistent with previous reports of cemiplimab.

218

项与瑞拉利单抗相关的新闻（医药）

2024-11-09

·PipelineReview

Immatics Announces Multiple Presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on TCR-T Therapy Candidates Targeting PRAME

Two oral presentations and multiple posters on clinical and preclinical-stage candidates to be presented at SITC, demonstrating the strength of Immatics’ TCR-T PRAME franchise to target solid cancers HOUSTON, TX and TUEBINGEN, Germany I November 8, 2024 I Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced an expanded clinical dataset from the ongoing Phase 1b dose expansion clinical trial for ACTengine® IMA203 in addition to updated Phase 1 dose escalation clinical data on its next-generation ACTengine® IMA203CD8 TCR-T cell therapy. For the first time, the Company also reported preclinical data on other next-generation T cell candidates and combination strategies as part of its strategy to further exploit opportunities in additional solid tumor types within its PRAME franchise. All dates and times of Immatics’ upcoming oral and poster presentations at the 39 th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) are available here . The data slides are accessible in the ‘ Events & Presentations ’ section of the Investor & Media section of the Company’s website. “Immatics remains fully focused on the clinical development of our most advanced lead product candidate, IMA203, in second-line or later metastatic melanoma patients. We look forward to the initiation of SUPRAME, the registration-enabling Phase 3 trial, in December,” said Dr. Cedrik Britten, Chief Medical Officer at Immatics. “Today, we also provide an update on our first, next-generation cell therapy, IMA203CD8, which is designed to achieve enhanced anti-tumor activity. The data announced confirm IMA203CD8’s enhanced pharmacology and potency per cell in patients. These attributes highlight the potential of this therapy in hard-to-treat solid tumors with medium-level PRAME copy numbers, including ovarian, endometrial and triple-negative breast cancer. The next step will be to further increase the cell dose to assess the full clinical potential of IMA203CD8 beyond melanoma. In addition, we strive to continuously improve the potential therapeutic benefit for patients with a range of PRAME-positive cancers through the expansion of our PRAME franchise.” ACTengine® IMA203 Monotherapy Phase 1b Trial – Clinical Data and Development Path Summary On October 10, 2024 , Immatics provided a data update on IMA203 monotherapy in 28 1 heavily pretreated metastatic melanoma patients from the ongoing Phase 1b dose expansion part of the clinical trial in which patients were treated at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR-T cells). The data announced today include all infused patients in the Phase 1b dose expansion part of the trial (N=41 2 ), consisting of the 28 melanoma patients reported on October 10, 2024, and 13 non-melanoma patients, of which 10 non-melanoma patients were reported on November 8, 2023. IMA203 monotherapy has maintained a favorable tolerability profile with no treatment-related Grade 5 events in the entire safety population (N=70 3 Phase 1a and Phase 1b patients across all dose levels and all tumor types). Best Overall Response for IMA203 in Dose Expansion in All Indications (N=41 # ) Data cut-off Aug 23, 2024; # First tumor assessment post infusion pending for 2/28 melanoma patients at data-cut; *Maximum change of target lesions and RECIST1.1 response at different timepoints. 1 Patient A-DL5-23 is off study at data cut-off; 2 Patient received one dose nivolumab erroneously. Development Path for IMA203 Based on the Phase 1b data, the Company is on track to commence SUPRAME, the registration-enabling Phase 3 randomized-controlled clinical trial in melanoma for IMA203, in December 2024. SUPRAME will evaluate IMA203 targeting PRAME in 360 HLA-A*02:01-positive patients with second-line or later (2L+) unresectable or metastatic melanoma who have received prior treatment with a checkpoint inhibitor. Patients will be randomized 1:1 for IMA203 or investigator’s choice of selected approved treatments in the 2L+ setting, including nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (US only) or chemotherapy. The primary endpoint for full approval will be median PFS and secondary endpoints will include objective response rate, safety, duration of response, no overall survival detriment and patient-reported outcomes. Patient enrollment for SUPRAME is forecast to be completed in 2026, and a pre-specified interim analysis is planned for early 2026. Immatics aims to submit a Biologics License Application (BLA) in early 2027 for full approval. ACTengine® IMA203CD8 (GEN2) Monotherapy Phase 1 Dose Escalation Trial – Patient Population & Clinical Data Summary Patient population: Heavily pretreated patients with solid tumors As of data cut-off on September 30, 2024, 44 4 heavily pretreated HLA-A*02:01 and PRAME-positive patients with solid tumors were infused with IMA203CD8 monotherapy across four escalating dose levels, of which 41 5 patients were evaluable for efficacy. The median total infused dose was 1.48×10 9 TCR-T cells, and the patient population is composed of patients with a median of three lines of prior systemic treatments. Safety: Treatment with IMA203CD8 demonstrates a manageable tolerability profile across dose levels IMA203CD8 monotherapy has maintained a manageable tolerability profile in the 44 patients treated. The most frequent adverse events at or above Grade 3 were expected cytopenia associated with lymphodepletion. Some patients also experienced mild to moderate CRS (Grade 1: 36% Grade 2: 48% Grade 3: 11% Grade 4: 2%). As previously reported, two patients experienced dose-limiting toxicities at dose level 4b, which prompted a dosing adjustment to dose level 4a. After further assessing the tolerability profile of IMA203CD8 in additional patients treated at dose level 4a, the eligibility criteria and the IL-2 dose regimen were modified, and dose escalation beyond dose level 4a was reinitiated. One Grade 5 adverse event classified as possibly related to treatment with IMA203CD8 was also observed as reported previously in March 2024. The maximum tolerated dose has not yet been determined. Anti-tumor activity and durability: Deep and durable objective responses observed Translational data: Opportunity of IMA203CD8 in medium-level PRAME expressing indications Translational data indicate that PRAME expression level is associated with clinical activity in IMA203 and IMA203CD8 treated patients. Both IMA203 and IMA203CD8 achieved deep responses despite IMA203CD8 patients receiving lower product doses. Based on the enhanced pharmacology of IMA203CD8, the evaluation of higher doses of IMA203CD8 in the ongoing dose escalation trial opens the possibility of addressing hard-to-treat solid tumor indications with a medium-level of PRAME copy numbers, such as ovarian cancer, endometrial cancers and triple-negative breast cancer. Preclinical Data on New Approaches for TCR-T Based Cell Therapies As part of Immatics’ long-term strategy to expand its PRAME franchise, the Company has conducted preclinical studies for the potential future clinical development of next-generation TCR-T-based cell therapies targeting PRAME to further enhance the efficacy and durability of IMA203. These efforts include the evaluation of TCR-T cells armored with membrane-bound IL-15 (mbIL15) targeting tumor types with low PRAME copy numbers, such as squamous non-small-cell lung cancer and squamous head and neck cancers. In addition, the Company is developing an allogeneic cell therapy approach to further increase commercial attractiveness and to reach patients quickly with its next-generation off-the-shelf cell therapy, ACTallo®. The preclinical data will be presented during poster sessions at SITC. About ACTengine® IMA203, IMA203CD8 and Target PRAME ACTengine ® IMA203 is Immatics’ most advanced TCR-based autologous cell therapy that is directed against an HLA-A*02-presented (human leukocyte antigen) peptide derived from preferentially expressed antigen in melanoma (PRAME), a protein frequently expressed in a large variety of solid cancers. PRAME is homogeneously and specifically expressed in tumor tissue and Immatics’ PRAME peptide is present at a high copy number per tumor cell. The peptide has been identified and characterized by Immatics’ proprietary mass spectrometry-based target discovery platform, XPRESIDENT ® . Through its proprietary TCR discovery and engineering platform XCEPTOR ® , Immatics has generated a highly specific T cell receptor (TCR) against this target for ACTengine ® IMA203. ACTengine ® IMA203 TCR-T is currently being evaluated as a monotherapy in a Phase 1 clinical trial in patients with solid tumors expressing PRAME, such as cutaneous melanoma. An IMA203 registration-enabling randomized controlled Phase 3 trial, “SUPRAME,” is planned to commence in December 2024. ACTengine® IMA203 TCR-T is also currently being evaluated in Phase 1 IMA203CD8 (GEN2) monotherapy, where IMA203 engineered T cells are co-transduced with a CD8αβ co-receptor. – END – About Immatics Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on X , Instagram and LinkedIn . 1 Includes one patient who started lymphodepletion but did not receive IMA203 TCR-T cells. 2 All infused patients, first tumor assessment post infusion pending for 2/28 melanoma patients at data-cut. 3 All patients who started lymphodepletion as of the data cut-off on August 23, 2024. 4 All patients who started lymphodepletion. 5 All infused patients with at least one tumor assessment postbaseline. 6 Metabolic CR on investigator-initiated PET month 14 post infusion. 7 Three patients excluded from tumor shrinkage analysis and figures due to lack of post-treatment assessment. 8 One patient had an early tumor assessment, outside the first assessment visit window and is not included in DCR calculation. SOURCE: Immatics

临床1期免疫疗法细胞疗法临床3期临床结果

2024-11-07

·GlobeNewswire-Health Care

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Third Quarter and Year to Date 2024

Significant Demand for Amtagvi™ (Lifileucel) Continues with $58.6M in Total 3Q24 Product Revenue Reaffirming Guidance of $160-$165M for FY24 and $450-$475M for FY25 of Total Product Revenue Marketing Authorization Applications Validated and Accepted for Review by European Regulatory Authorities for Potential Approval Starting with the UK in 1H2025 and EU and Canada in 2H2025 Enrollment Accelerating in IOV-LUN-202 Registrational Phase 2 Trial in Post-anti-PD-1 NSCLC SAN CARLOS, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported third quarter and year to date 2024 financial results and corporate updates. Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Iovance is executing a successful U.S. commercial launch of Amtagvi™ for patients with previously treated advanced melanoma. Robust demand for Amtagvi and Proleukin® continues to grow as our expanding network of authorized treatment centers (ATCs) and outreach to community oncologists broaden the utilization of Amtagvi, driving a higher volume of patient referrals. Demand trends are expected to accelerate growth throughout the remainder of the year and over the following years. As such, we are actively pursuing additional regulatory approvals to expand our commercial footprint, driving growth beyond the U.S. into new markets with a high prevalence of advanced melanoma. As a fully integrated company, Iovance is well positioned to remain the global leader in innovating, developing, and delivering current and future generations of TIL cell therapy for patients with cancer.” Third Quarter and Year to Date 2024 Financial Results, Corporate Guidance, and Updates Product Revenue and Guidance 3Q24 Total Product Revenue: Iovance recognized total revenue of $58.6 million from sales of Amtagvi and Proleukin during the third quarter ended September 30, 2024. Amtagvi Revenue: Product revenue was $42.1 million from U.S. Amtagvi sales in the third quarter of 2024, reflecting increasing strong demand and adoption. The Amtagvi launch, with revenue recognized upon patient infusion, began during the second quarter of 2024.Proleukin Revenue: Product revenue also included $16.5 million of Proleukin sales in the third quarter of 2024. Proleukin is used in the Amtagvi treatment regimen and other commercial and clinical settings. Proleukin revenue is recognized upon delivery to distributors and ATCs and purchased several months in advance of anticipated infusions and Amtagvi revenue recognition. Year to Date Total Product Revenue and Infusions: Through the end of the third quarter of 2024, $90.4 million in total product revenue has been recognized following the U.S. launch of Amtagvi on February 20, 2024. Amtagvi Infusions: A total of 146 patients have been infused with Amtagvi since the first commercial infusion in April 2024, including 25 patients infused in the second quarter, 82 patients infused in the third quarter, and 39 patients infused since the start of the fourth quarter.Amtagvi and Proleukin Revenue: Amtagvi and Proleukin revenue is $54.9 million and $35.5 million year to date, respectively. FY24 and FY25 Total Product Revenue Guidance: Amtagvi adoption is on track to continue accelerating, driven by broader utilization, higher demand from our expanding ATC network, and growth in community referrals. Iovance is reaffirming its guidance for FY24 and FY25 and expects quarter-over-quarter product revenue growth for the fourth quarter of 2024, full year 2025, and beyond. Revenue Guidance in FY24: Total product revenue for the full year 2024 continues to be within the range of $160 to $165 million, reflecting three quarters of Amtagvi sales following U.S. Food and Drug Administration (FDA) approval in mid-February.Revenue Guidance in FY25: Total product revenue remains on track to be within the range of $450 to $475 million in 2025, the first full calendar year of Amtagvi sales. Gross margins are increasing as the launch advances and are expected to surpass 70% over the next several years. In line with anticipated growth in Amtagvi demand, Proleukin revenue is also expected to increase significantly in 2025 and beyond. Cash Position: As of September 30, 2024, Iovance had cash, cash equivalents, investments, and restricted cash of $403.8 million. The current cash position and anticipated product revenue are expected to be sufficient to fund current and planned operations, including manufacturing expansion, into early 2026. Amtagvi (Lifileucel) U.S. Launch Highlights in Advanced Melanoma The U.S. FDA approved Amtagvi (lifileucel) on February 16, 2024, as the first treatment option for patients with advanced melanoma after anti-PD-1 and targeted therapy. Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication.Onboarding is complete at 56 U.S. ATCs across 29 states and more than 90% of addressable patients are now located within 200 miles of an ATC. Approximately 70 ATCs remain on track to be onboarded by the end of 2024.Manufacturing turnaround time has been on target, with launch expectations of approximately 34 days from inbound to return shipment to ATCs. With efforts underway, turnaround time is expected to be reduced in the near term. The commercial manufacturing experience is consistent with prior clinical experience.Amtagvi is a preferred second-line or subsequent therapy in the National Comprehensive Cancer Network® guidelines for treatment of cutaneous melanoma.Reimbursement remains successful, with an average financial clearance time of about three weeks.Approximately 75% of enrolled Amtagvi patients are covered by private payers. To date, payers or plans covering more than 250 million lives have added Amtagvi to policies since its launch. Lifileucel Launch Expansion into New Markets Amtagvi has the potential to address more than 20,000 patients annually with previously treated advanced melanoma across the U.S. and multiple global markets where regulatory submissions have been submitted or are planned for 2024 and 2025.1Regulatory dossiers are under review, submitted, or planned across multiple international markets for lifileucel for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. If approved, lifileucel will be the first and only approved therapy in this treatment setting in all markets. A marketing authorization application (MAA) for all EU member states was validated and accepted for review by the European Medicines Agency for potential approval in the second half of 2025.An MAA was submitted to the Medicines and Healthcare products Regulatory Agency in the United Kingdom for potential approval in the first half of 2025.A near-term new drug submission (NDS) was deemed eligible for Notice of Compliance with Conditions (NOC/c) by Health Canada. The NOC/c policy includes a prioritized 200-day review process for potential NDS approval in mid-2025.Additional regulatory dossiers remain on track for submission in 2025 and 2026 in markets with significant populations of previously treated advanced melanoma patients, including Australia in the first half of 2025 and Switzerland in the second half of 2025. Iovance TIL Cell Therapy Pipeline Highlights Lifileucel in Frontline Advanced Melanoma Updated clinical data from Cohort 1A of the IOV-COM-202 trial was presented at ASCO 2024 and demonstrated an unprecedented rate, depth and durability of responses, including a 30% confirmed complete response rate, and a differentiated safety profile in advanced melanoma patients who were naive to immune checkpoint inhibitors.Cohort 1D in the IOV-COM-202 trial is exploring lifileucel in combination with nivolumab and relatlimab in patients with frontline advanced melanoma, representing another potential best-in-class frontline alternative for physicians and patients in the U.S.Strong momentum continues with global site activation and patient enrollment in the TILVANCE-301 trial, with nearly 50 active sites across 11 countries, including the U.S., Europe, Australia, and Canada, and more than 50 additional sites across 15 countries committed to join the trial. TILVANCE-301 is intended to support accelerated and full U.S. approvals of Amtagvi in combination with pembrolizumab in frontline advanced melanoma, as well as full approval of Amtagvi in post-anti-PD-1 melanoma. Lifileucel in Non-Small Cell Lung Cancer (NSCLC) Enrollment is accelerating in the IOV-LUN-202 registrational Phase 2 trial in post-anti-PD-1 NSCLC with high demand at clinical sites in the U.S., Canada, and Europe. Iovance is also activating sites in additional regions with strong track records for enrollment in NSCLC studies. Iovance expects to present updated data from the IOV-LUN-202 trial at a medical conference in 2025. The FDA previously provided positive regulatory feedback on the proposed potency matrix for lifileucel in NSCLC, as well as the single-arm IOV-LUN-202 trial design to support accelerated approval of lifileucel in post-anti-PD-1 NSCLC.Iovance expects data from the IOV-LUN-202 trial to support a potential accelerated U.S. approval for lifileucel in NSCLC in 2027. Updated preliminary results from Cohort 3A in the IOV-COM-202 trial continue to demonstrate robust response rates and durability for lifileucel in combination with pembrolizumab in NSCLC patients who were not previously treated with immune checkpoint inhibitor therapy. A confirmed objective response was observed in 9 of 14 EGFR wild type patients (64.3%), including 6 of 11 (54.5%) patients who also had difficult-to-treat PD-L1 negative disease.Median duration of response (DOR) was not reached at a median study follow up of 26.5 months.This data supports the opening of a new cohort, 3D, in the IOV-COM-202 trial to investigate lifileucel plus pembrolizumab following chemotherapy as part of frontline therapy for patients with EGFR wild type NSCLC, representing the majority of patients with an unmet medical need in this setting.Additional Cohort 3A results are available in a late-breaking poster that will be presented at the upcoming Society for Immunotherapy of Cancer Annual Meeting (SITC) on November 9, 2024 Lifileucel in Endometrial Cancer Patient enrollment commenced in the IOV-END-201 Phase 2 trial to investigate lifileucel for advanced endometrial cancer patients who have progressed after platinum-based chemotherapy and anti-PD-1 therapy regardless of mismatch repair (MMR) status. IOV-END-201 is supported by preclinical and manufacturing success data presented at the International Gynecologic Cancer Society (IGCS) 2024 annual global meeting in October 2024, as well as positive feedback from gynecological oncology experts.Endometrial cancer represents a significant opportunity for TIL cell therapy to address an additional unmet medical need in the post-anti-PD-1 treatment setting and may address both mismatch repair deficient and proficient tumors. There are no currently approved therapies in the second-line setting after frontline post-anti-PD-1 therapy and chemotherapy. Next Generation TIL Pipeline IOV-4001 (PD-1 Inactivated TIL Cell Therapy): The first in human IOV-GM1-201 trial to investigate PD-1 inactivated TIL cell therapy (IOV-4001) in previously treated advanced melanoma and NSCLC is in the multi-center Phase 2 efficacy stage. Iovance continues to utilize the TALEN® technology licensed from Cellectis to develop other investigational gene-edited TIL cell therapies with multiple knockout targets to potentially improve efficacy.Next Generation IL-2 for TIL Treatment Regimen: An Investigational New Drug application (IND) was submitted and allowed to proceed for a Phase 1/2 clinical trial of IOV-3001, a second-generation, modified interleukin-2 (IL-2) analog, for use in the TIL therapy treatment regimen. Non-human primate and IND-enabling studies of IOV-3001 demonstrated the potential for improved safety with strong effector T cell expansion.Next Generation, Cytokine-Tethered TIL Therapy: IND-enabling studies are proceeding for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 (IL-12) TIL cell therapy. A clinical trial of a prior generation IL-12 TIL therapy at the National Cancer Institute showed improved efficacy with low cell doses and provides the rationale for modifying IOV-5001 to enhance TIL efficacy while optimizing safety. In preclinical studies, IOV-5001 drove superior antitumor activity in a simulated tumor microenvironment. These results will be featured in a poster at SITC on November 9, 2024. Iovance plans to submit a pre-IND meeting request to FDA in 2024 and commence clinical development for multiple indications in 2025. Manufacturing Capacity Expansion The Iovance Cell Therapy Center (iCTC), and an FDA-approved contract manufacturer, currently have capacity to treat several thousands of patients annually. Expansion is currently underway for the iCTC campus to supply TIL cell therapies to more than 5,000 patients annually in the next few years. Iovance is also developing a manufacturing network to address more than 10,000 patients annually. Corporate Updates Iovance currently owns more than 230 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies that are expected to provide Amtagvi with exclusivity through at least 2042. This patent portfolio covers TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity for Amtagvi into 2038 and additional patent rights, including methods of treating melanoma and compositions and methods for potency assays, expected to provide exclusivity into 2039 and 2042, respectively. Iovance also owns an industry-leading patent portfolio covering TIL products produced with genetic engineering, using core biopsies and peripheral blood as starting material, and using combinations of TIL products with checkpoint inhibitors, as well as Iovance’s proprietary IovanceCares™ system. More information on Iovance’s patent portfolio is available on the Intellectual Property page on www.iovance.com. Third Quarter and Year to Date 2024 Financial Results As of September 30, 2024, Iovance’s cash position is approximately $403.8 million, which includes net proceeds of approximately $200.0 million raised from an at-the market (ATM) equity financing facility during the second and early third quarter of 2024. The current cash position and anticipated product revenue are expected to be sufficient to fund current and planned operations into early 2026. Net loss for the third quarter of 2024 was $83.5 million, or $0.28 per share, compared to a net loss of $113.8 million, or $0.46 per share, for the third quarter ended September 30, 2023. Net loss for the first nine months of 2024 was $293.6 million, or $1.03 per share, compared to a net loss of $327.7 million, or $1.44 per share, for the nine-month period ended September 30, 2023. Revenue was $58.6 million for the third quarter of 2024 and consisted of product revenue from Amtagvi sales as well as recurring revenue from Proleukin. Iovance recognized $42.1 million in revenue from Amtagvi infusions that were completed during the third quarter of 2024 and $16.5 million in global revenue for Proleukin. Revenue for the first nine months of 2024 was $90.4 million and reflected product revenue from Proleukin and Amtagvi. Revenue for the first nine months of 2023 was $0.7 million for global sales of Proleukin, which Iovance began to recognize during the three-month period ended June 30, 2023. The increases in revenue in the third quarter and first nine months of 2024 over the prior year periods were primarily attributable to the U.S. launch of Amtagvi, including revenue recognized for Amtagvi, as well as significant growth in U.S. Proleukin revenue for use in the Amtagvi treatment regimen, beginning in the second quarter of 2024. Cost of sales includes inventory, overhead and related cash and non-cash expenses that are directly associated with sales of Amtagvi and Proleukin, as well as manufacturing costs for Amtagvi. Cost of sales for the three months ended September 30, 2024 was $39.8 million, primarily attributed to $8.3 million in period costs associated with patient drop off and manufacturing success rates, $5.5 million for non-cash amortization expense for intangible assets, and $3.9 million in royalties payable on product sales. Cost of sales for the three months ended September 30, 2023 was $4.3 million, primarily related to non-cash amortization for intangible assets. Cost of sales for the nine months ended September 30, 2024 was $78.5 million, primarily related to $17.2 million in certain costs associated with patient drop off and manufacturing success rates, $15.5 million in non-cash amortization expense for intangible assets, and $8.2 million royalties payable on product sales. Cost of sales for the nine months ended September 30, 2023 was $6.4 million, primarily related to non-cash amortization for intangible assets. The increases in cost of sales in the third quarter and year to date 2024 over the prior year periods were primarily attributable to the initiation of product sales, commercial manufacturing and related cash and non-cash expenses tied to the U.S. launch of Amtagvi that began during the first quarter of 2024. Research and development expenses were $68.2 million for the third quarter of 2024, a decrease of $19.3 million compared to $87.5 million for the same period ended September 30, 2023. Research and development expenses were $210.1 million for the first nine months of 2024, a decrease of $46.5 million compared to $256.6 million for the same period ended September 30, 2023. The decreases in research and development expenses in the third quarter and year to date 2024 over the prior year periods were primarily attributable to the transition of Amtagvi to commercial manufacturing, decreased costs associated with certain clinical activities, and the completion of pre-commercial qualification activities in 2023. These decreases in research and development were partially offset by increases in headcount and related costs, including stock-based compensation resulting from growth in headcount. Selling, general and administrative expenses were $39.6 million for the third quarter of 2024, an increase of $12.6 million compared to $27.0 million for the same period ended September 30, 2023. Selling, general and administrative expenses were $110.5 million for the first nine months of 2024, an increase of $33.5 million compared to $77.0 million for the prior year’s nine-month period. The increase in selling, general and administrative expenses in the third quarter and year to date 2024 compared to the prior year periods was primarily attributable to increases in headcount and related costs, including stock-based compensation, to support the growth in the overall business and related corporate infrastructure, as well as legal costs and costs incurred to support the commercialization of Amtagvi and Proleukin. For additional information, please see the Company’s Selected Condensed Consolidated Balance Sheets and Statements of Operations below. Webcast and Conference Call Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 4:30 p.m. ET. To listen to the live or archived audio webcast, please register at https://edge.media-server.com/mmc/p/vxykqwaf. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year. 1. World Health Organization International Agency for Research on Cancer (IARC) GLOBOCAN 2022. About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi™ is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com. Amtagvi™ and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Forward-Looking Statements Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration (“FDA”) approval, and Proleukin, for which we have obtained FDA and European Medicines Agency (“EMA”) approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues may not continue to serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global pandemic; the effects of global and domestic geopolitical factors; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. IOVANCE BIOTHERAPEUTICS, INC.Selected Condensed Consolidated Balance Sheets(in thousands) September 30, 2024(unaudited) December 31, 2023Cash, cash equivalents, and investments $397,488 $279,867Restricted cash $6,355 $66,430Total assets $991,115 $780,351Stockholders' equity $773,455 $584,613 Condensed Consolidated Statements of Operations(unaudited, in thousands, except per share information) For the Three Months Ended For the Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Revenues Product revenue $58,555 $469 $90,376 $707 Total revenue 58,555 469 90,376 707 Costs and expenses* Costs of sales $39,823 $4,340 $78,452 $6,390 Research and development 68,245 87,526 210,112 256,607 Selling, general and administrative 39,553 26,964 110,514 77,013 Total costs and expenses 147,621 118,830 399,078 340,010 Loss from operations (89,066) (118,361) (308,702) (339,303)Other income Interest income, net 4,005 3,358 10,698 9,925 Net Loss before income taxes $(85,061) $(115,003) $(298,004) $(329,378)Income taxes benefit 1,520 1,243 4,386 1,720 Net Loss $(83,541) $(113,760) $ (293,618) $ (327,658) Net Loss Per Share of Common Stock, Basic and Diluted $(0.28) $(0.46) $(1.03) $(1.44) Weighted-Average Shares of Common Stock Outstanding, Basic and Diluted 303,269 245,817 284,836 228,115 *Includes stock-based compensation as follows: Cost of sales $3,065 $— $5,362 $— Research and development 13,803 8,787 35,825 27,036 Selling, general and administrative 14,138 7,034 37,463 21,190 Total stock-based compensation included in costs and expenses $31,006 $15,821 $78,650 $48,226 CONTACTS Iovance Biotherapeutics, Inc.: Sara Pellegrino, IRC SVP, Investor Relations & Corporate Communications 650-260-7120 ext. 264 Sara.Pellegrino@iovance.com Jen Saunders Senior Director, Investor Relations & Corporate Communications 267-485-3119 Jen.Saunders@iovance.com

临床结果上市批准临床2期免疫疗法细胞疗法

2024-11-06

·GlobeNewswire-Health Care

Immunocore reports third quarter financial results and provides a business update

Immunocore reports third quarter financial results and provides a business update KIMMTRAK® (tebentafusp-tebn) net revenues of $80.2 million in 3Q 2024, 28% growth over 3Q 2023 Phase 3 trials in cutaneous melanoma ongoing (PRISM-MEL-301 and TEBE-AM); and Phase 3 trial in adjuvant uveal melanoma (ATOM) to start randomizing in 4Q 2024 Presented Phase 1 brenetafusp data in platinum-resistant ovarian cancer patients; ongoing signal detection in metastatic NSCLC will shift initial data release; focus now on earlier-line patients and combinations 3Q 2024 earnings per share (EPS) of $0.17 compared to 3Q 2023 EPS of $0.02 (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US, 06 November 2024) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announced its financial results for the third quarter ended September 30, 2024 and provided a business update. “We are proud to report another strong quarter, marking two years of continuous growth for KIMMTRAK and another quarter of positive net income,” said Bahija Jallal, Immunocore’s Chief Executive Officer. “We are also making significant strides in advancing our broad pipeline – with brenetafusp in oncology, the HIV functional cure trial in infectious diseases, and in autoimmune diseases with tissue-targeted programs for type 1 diabetes and dermatologic diseases.” “KIMMTRAK’s 28% growth over Q3 last year is driven by higher demand in the United States and Germany and by expanded patient reach with 11 launches this year,” said Ralph Torbay, Immunocore’s Chief Commercial Officer. “We are excited about the potential to bring KIMMTRAK to more patients with melanoma through the Phase 3 TEBE-AM trial that is expected to complete enrollment in early 2026, and the Phase 3 ATOM trial that is planned to start randomization this quarter.” Third Quarter 2024 Highlights (including post-period) KIMMTRAKThe Company’s lead product, KIMMTRAK, is approved in 38 countries and has been launched in 21 countries globally to date for HLA-A*02:01 positive patients with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched. The Company sees three key growth areas for KIMMTRAK: continued expansion in mUM, the potential expansion into 2L+ advanced cutaneous melanoma and adjuvant uveal melanoma. Metastatic uveal melanoma KIMMTRAK net product sales were $80.2 million and $225.9 million for the three and nine months ended September 30, 2024, respectively, representing increases of 28% and 32% respectively, compared to the prior year periods.Growth in the US and Germany was driven by increased demand based on continued community penetration and growing duration of treatment.New baseline blood gene expression signature data was presented at the European Society for Medical Oncology 2024 Meeting (ESMO 2024) confirming that T cell fitness in blood is an important parameter of clinical activity for KIMMTRAK in previously treated uveal melanoma. 2L+ previously treated cutaneous melanoma Randomization continues in the registrational Phase 3 trial (TEBE-AM), which includes three arms – KIMMTRAK monotherapy, KIMMTRAK in combination with pembrolizumab, and control. The Company expects to complete randomization in the first half of 2026.The TEBE-AM Phase 3 trial in 2L+ cutaneous melanoma has a primary endpoint of overall survival. Adjuvant uveal (or ocular) melanoma Randomization in the ATOM Phase 3 trial, led by the European Organisation for Research and Treatment of Cancer (EORTC), is on track to start in the fourth quarter of 2024.ATOM is currently the only active registrational Phase 3 trial in adjuvant uveal melanoma. PRAME Brenetafusp (IMC-F106C) is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab, in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line advanced cutaneous melanoma and in a Phase 1/2 clinical trial, as monotherapy and in combination, across multiple tumor types, including ovarian, non-small cell lung (NSCLC), and endometrial carcinoma. PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced or metastatic HLA-A*02:01 positive cutaneous melanoma Ongoing randomization of patients in PRISM-MEL-301 in multiple countries.Trial is evaluating brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab. Phase 1/2 clinical trial of brenetafusp (PRAME-A02) in multiple solid tumors Clinical data presented at ESMO 2024 from the Phase 1 trial in patients with heavily pre-treated platinum-resistant high grade serous ovarian cancer showed signals of activity in heavily pretreated, platinum resistant patients. Disease control rate was 58% in monotherapy patients and 69% for combination patients. Overall survival (OS) was still maturing (73% 6-months OS rate in the monotherapy cohort). ctDNA molecular response rate was 31% and 82%, respectively, in the monotherapy and combination cohorts, associated with longer progression free survival and OS. Brenetafusp is well tolerated as monotherapy and in combination with gemcitabine, nab-paclitaxel and pegylated doxorubicin.Data presented at ESMO 2024 showed peripheral blood T cell fitness signature is an important parameter of brenetafusp clinical activity in ovarian cancer and uveal melanoma.The Company is currently evaluating brenetafusp in combination with non-platinum chemotherapies in platinum resistant ovarian cancer and with bevacizumab and with platinum chemotherapy in earlier lines of platinum sensitive ovarian cancer.The Company continues signal detection for brenetafusp in metastatic non-small-cell lung cancer cohorts, including in combination with docetaxel and with osimertinib in earlier-line NSCLC. As a result, the Company will not release initial data in the fourth quarter of 2024. IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24) On track for first patient to be treated in the Phase 1 trial with IMC-P115C in first half of 2025. Additional Oncology Candidates IMC-R117C (first PIWIL1-A02 targeted immunotherapy) for colorectal and other gastrointestinal cancersThe Company has leveraged its proprietary peptidomic database to validate a novel target, PIWIL1. PIWIL1 is a negative prognostic marker and is expressed across a range of tumors including colorectal, which is historically insensitive to immune checkpoints, as well as gastro-esophageal, and pancreatic cancer. Remain on track to treat the first patient in the Phase 1/2 trial of IMC-R117C in the fourth quarter of 2024.The Phase 1/2 trial will assess the safety and clinical activity of IMC-R117C, as a monotherapy and in combination with standards of care, in colorectal and other gastrointestinal cancers. ImmTAV candidates for a functional cure in infectious diseasesThe Company’s bispecific TCR technology platform has potential to offer a new approach for the treatment of chronic infections and aims to eliminate evidence of remaining virus in circulation after the patient stops taking medication - known as a "functional cure". Two investigational candidates are in Phase 1 clinical trials for people living with human immunodeficiency virus (HIV) and people with chronic Hepatitis B infection (HBV). Phase 1 trial of IMC-M113V (Gag-A02) for people living with HIV The objective of the clinical trial is to identify a safe and tolerable dose and evaluate whether IMC-M113V could lead to reduction in the viral reservoir and, after stopping antiretroviral therapies and IMC-M113V, delay or prevent HIV rebound.A biologically active dose in the multiple ascending dose (MAD) portion of the trial has been reached and the Company is enrolling more people living with HIV to characterize anti-viral activity and to explore higher doses with data expected in the first quarter of 2025. Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV Expect to complete the single ascending dose (SAD) portion of the trial in the fourth quarter of 2024. Tissue-specific down modulation of the immune system for autoimmune diseasesThe Company is expanding its platform into autoimmune diseases with two new, first-in-class bispecific candidates recently entering its pipeline. The key differentiator of the Company’s ImmTAAI (Immune Modulating Monoclonal TCRs Against AutoImmune disease) platform is tissue-specific down modulation of the immune system whereby, when tethered to the tissue of interest, the new candidates suppress pathogenic T cells via PD1 receptor agonism. IMC-S118AI (pre-pro insulin A02 x PD1), intended for disease-modifying treatment in type 1 diabetes IMC-S118AI recognizes a peptide from pre-proinsulin presented by HLA-A02 on beta cells, coupled with a PD1 agonist effector arm. Undisclosed non-HLA restricted (universal) candidate for inflammatory dermatological diseases The candidate is an antigen presenting cell (APC) tethered ImmTAAI and is not HLA restricted (i.e. universal for all populations). Corporate Updates In August, Chief Financial Officer (CFO) and Head of Strategy, Brian Di Donato, informed the Company of his plans to leave at the end of the year, to take the role of Chief Executive Officer at a private, early-stage biotech headquartered in San Diego, California. The Company is progressing in its search for a new CFO. Brian will remain as the Company’s CFO and Head of Strategy through the end of 2024, to ensure a smooth transition. Financial ResultsFor the third quarter ended September 30, 2024, the Company generated net product sales of $80.2 million compared to $62.6 million for the same period in 2023. This increase was due to revenue from KIMMTRAK, of which $57.3 million was in the United States, $21.0 million in Europe, and $1.9 million in international regions. The increase in net product sales was due primarily to increased volume in the United States and global country expansion, as the Company continued its commercialization efforts. For the third quarter ended September 30, 2024, research and development (R&D) expenses were $52.8 million, compared to $43.2 million for the same period in 2023. This increase was primarily driven by expenses incurred for the tebentafusp programs, including the Phase 3 trials: TEBE-AM in previously treated advanced cutaneous melanoma and ATOM in adjuvant uveal melanoma. For the quarter ended September 30, 2024, SG&A expenses were $35.5 million, compared to $35.5 million for the same period in 2023. Basic and diluted earnings per share was $0.17 for the quarter ended September 30, 2024, as compared to a basic and diluted earnings per share of $0.02 for the same period in 2023. Net income for the quarter ended September 30, 2024 was $8.7 million, as compared to $0.9 million for the same period in 2023. Cash, cash equivalents, and marketable securities at September 30, 2024 were $901.3 million. The Company plans to use existing cash to repay its $50 million loan by the end of 2024 and also expects to pay approximately $40 million in sales-related rebate accruals in the fourth quarter of 2024. About ImmTAC® molecules for cancer Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumors. About ImmTAV® molecules and infectious diseases ImmTAV (Immune mobilizing monoclonal TCRs Against Virus) molecules are novel bispecifics that are designed to enable the immune system to recognize and eliminate virally infected cells. Immunocore is advancing clinical candidates to achieve functional cure for patients with HIV and hepatitis B virus (HBV). The Company aims to achieve sustained control of HIV after patients stop anti-retroviral therapy (ART), without the risk of virological relapse or onward transmission. This is known as ‘functional cure’. For the treatment of HBV, the Company aims to achieve sustained loss of circulating viral antigens and markers of viral replication after stopping medication for people living with chronic HBV. About ImmTAAITM molecules and autoimmune diseases ImmTAAI (Immune mobilizing monoclonal TCRs Against AutoImmune disease) molecules are novel bispecifics that are designed for tissue-specific down modulation of the immune system. When tethered to the tissue of interest, ImmTAAI candidates suppress pathogenic T cells via PD1 receptor agonism. The Company is currently advancing two candidates for autoimmune diseases, including type 1 diabetes and inflammatory dermatological diseases. About PRISM-MEL-301 (NCT06112314) – Phase 3 trial with brenetafusp (IMC-F106C, PRAME-A02) in 1L advanced cutaneous melanoma The Phase 3 registrational trial is randomizing HLA-A*02:01-positive patients with previously untreated advanced melanoma, to brenetafusp + nivolumab versus nivolumab or nivolumab + relatlimab, depending on the country where the patient is enrolled. The trial will initially randomize to three arms: two brenetafusp dose regimens (40 mcg and 160 mcg) and a control arm. One of the two brenetafusp dose regimens will be discontinued after an initial review of the first 60 patients randomized to the two experimental arms (90 patients randomized total). The primary endpoint of the trial is progression free survival (PFS) by blinded independent central review (BICR), with secondary endpoints of overall survival (OS) and overall response rate (ORR). About the IMC-F106C-101 Phase 1/2 trial IMC-F106C-101 is a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumors, including non-small cell lung cancer (NSCLC), small-cell lung cancer (SCLC), endometrial, ovarian, cutaneous melanoma, and breast cancers. The Phase 1 dose escalation trial was designed to determine the maximum tolerated dose (MTD), as well as to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-F106C (brenetafusp), a bispecific protein built on Immunocore’s ImmTAC technology, and the Company’s first molecule to target the PRAME antigen. The Company is enrolling patients into three expansion arms in NSCLC, as well as ovarian and endometrial carcinomas. The IMC-F106C-101 trial is adaptive and includes the option for Phase 2 expansion, allowing for approximately 100 patients treated per tumor type in the Phase 1 and 2 expansion arms. Dose escalation continues in additional solid tumors as well as plans for combination arms with standards-of-care, including checkpoint inhibitors, chemotherapy, and tebentafusp. About TEBE-AM – Phase 3 registrational trial with tebentafusp in previously treated advanced cutaneous melanoma The trial is randomizing patients with second-line or later advanced cutaneous melanoma who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor. Patients are randomized to one of three arms, including tebentafusp – as monotherapy or in combination with an anti-PD1 – or a control arm. The primary endpoint is overall survival. About the ATOM Phase 3 trial – Phase 3 registrational trial with tebentafusp in adjuvant uveal melanoma The EORTC-led Phase 3 clinical trial will include sites in 10 EU countries and the United States and will randomize HLA-A*02:01-positive patients with high-risk primary uveal melanoma after definitive treatment, by surgery or radiotherapy, and no evidence of metastatic disease on imaging. The trial is expected to enroll a total of 290 patients who will be randomized 1:1 to one of two arms: tebentafusp as monotherapy or observation. The primary endpoint of the trial is relapse-free survival (RFS), with secondary objectives of overall survival and safety and tolerability of tebentafusp. Exploratory objectives include comparison of health-related quality of life between the treatment arms and evaluation of the role of circulating tumor DNA (ctDNA) as a biomarker for the presence of residual disease. About Uveal Melanoma Uveal melanoma is a rare and aggressive form of melanoma affecting the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK. About Cutaneous Melanoma Cutaneous melanoma (CM) is the most common form of melanoma. It is the most aggressive skin carcinoma and is associated with the vast majority of skin cancer-related mortality. The majority of patients with CM are diagnosed before metastasis but survival remains poor for the large proportion of patients with metastatic disease. Despite recent progress in advanced melanoma therapy, there is still an unmet need for new therapies that improve first-line response rates and duration of response as well as for patients who are refractory to first-line treatments. About KIMMTRAK® KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform, designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom. IMPORTANT SAFETY INFORMATION Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK, with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS. Skin Reactions Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions. Elevated Liver Enzymes Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity. Embryo-Fetal Toxicity KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose. The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate. For more information, please see full Summary of Product Characteristics (SmPC) or full U.S. Prescribing Information (including BOXED WARNING for CRS). About KIMMTRAKConnect Immunocore is committed to helping patients who need KIMMTRAK obtain access via our KIMMTRAKConnect program. The program provides services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and site of care coordination. To learn more, visit KIMMTRAKConnect.com or call 844-775-2273. About Immunocore Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune diseases and infectious diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including nine active clinical and pre-clinical programs in oncology, infectious diseases, and autoimmune diseases. The Company’s most advanced oncology TCR therapeutic, KIMMTRAK, has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “believe”, “expect”, “plan”, “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, statements regarding the commercial performance of KIMMTRAK, including the Company’s plans to expand distribution of KIMMTRAK to additional jurisdictions once regulatory approval is received; the potential benefits and advantages that KIMMTRAK will provide for patients, including its potential for expansion into other indications such as cutaneous and adjuvant uveal melanoma; expectations regarding the design, progress, timing, enrollment, randomization, scope, expansion, funding, and results of the Company’s existing and planned clinical trials; the timing and sufficiency of clinical trial outcomes to support potential approval of any of the Company’s product candidates or those of, or combined with, its collaboration partners; the Company’s goals to develop and commercialize product candidates based on its KIMMTRAK platform alone or with collaboration partners; the potential regulatory approval, expected clinical benefits and availability of the Company’s product candidates; and the use of the Company’s cash, cash equivalents and marketable securities, including the Company’s intent to repay in full its outstanding loan under the Pharmakon debt facility and make payments of sales-related rebate accruals. Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company’s control. These risks and uncertainties include, but are not limited to, the impact of worsening macroeconomic conditions on the Company’s business, financial position, strategy and anticipated milestones, including Immunocore’s ability to conduct ongoing and planned clinical trials; Immunocore’s ability to obtain a clinical supply of current or future product candidates or commercial supply of KIMMTRAK or any future approved products; Immunocore’s ability to obtain and maintain regulatory approval of its product candidates, including KIMMTRAK; Immunocore’s ability and plans in continuing to establish and expand a commercial infrastructure and to successfully launch, market and sell KIMMTRAK and any future approved products; Immunocore’s ability to successfully expand the approved indications for KIMMTRAK or obtain marketing approval for KIMMTRAK in additional geographies in the future; the delay of any current or planned clinical trials, whether due to patient enrollment delays or otherwise; Immunocore’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or future regulatory approval; Immunocore’s need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions, including changes in inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the war in Ukraine, the conflict in the Middle East, and global geopolitical tension; Immunocore’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any of its product candidates it or its collaborators are developing; and the success of Immunocore’s current and future collaborations, partnerships or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section titled "Risk Factors" in Immunocore’s filings with the Securities and Exchange Commission, including Immunocore’s most recent Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on February 28, 2024, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law. Contact Information Immunocore Sébastien Desprez, Head of CommunicationsT: +44 (0) 7458030732E: sebastien.desprez@immunocore.comFollow on Twitter: @Immunocore Investor RelationsClayton Robertson, Head of Investor RelationsT: +1 (215) 384-4781E: ir@immunocore.com Immunocore Holdings plcCondensed Consolidated Statement of OperationsComparison of the Quarters and Year to Date Ended September 30, 2024 and 2023(In thousands, except share and per share data)(Unaudited) Quarter Ended Year to Date September 30, 2024September 30, 2023 September 30, 2024September 30, 2023Product revenue, net$80,248$62,629 $225,937$171,142Collaboration revenue—2,221 2138,124Total revenue80,24864,850 226,150179,266Cost of product revenue(448)(276) (2,401)(837)Research and development expense(52,770)(43,249) (161,301)(117,980)Selling, general, & administrative expense(35,532)(35,469) (113,457)(103,046)Loss from operations(8,502)(14,144) (51,009)(42,597)Interest income5,9605,142 20,44512,546Interest expense(4,290)(1,321) (11,806)(3,845)Foreign currency gain (loss)3,96311,246 1,049(647)Other income (expense), net8,962(192) 13,205(706)Net income (loss) before income taxes6,093731 (28,116)(35,249)Income tax benefit (expense)2,643175 800(308)Net income (loss)$8,736$906 $(27,316)$(35,557) Basic net income (loss) per share$0.17$0.02 $(0.55)$(0.73)Basic weighted average number of shares50,021,93949,134,037 49,971,26748,671,732 Diluted net income (loss) per share$0.17$0.02 $(0.55)$(0.73)Diluted weighted average number of shares52,808,43454,158,967 49,971,26748,671,732 Immunocore Holdings plcCondensed Consolidated Balance Sheets(In thousands)(Unaudited) September 30, 2024December 31, 2024ASSETS Current assets Cash and cash equivalents$537,767$442,626Marketable securities363,515—Accounts receivable, net63,65952,093Prepaid expenses and other current assets36,44629,600Inventory, net4,5184,501Total current assets1,005,905528,820Property and equipment, net9,1609,215Operating lease right of use assets, net39,67233,520Deferred tax assets, net12,66310,973Other non-current assets17,23814,473Total assets$1,084,638$597,001 Liabilities and shareholders’ equity Current liabilities Accounts payable$19,721$17,798Accrued expenses and other current liabilities197,224119,835Operating lease liabilities, current1,0971,388Interest-bearing loans and borrowings, current48,207—Total current liabilities266,249139,021Accrued expenses, non-current3,006978Deferred revenue, non-current5,7975,515Operating lease liabilities, non-current41,27134,633Interest-bearing loans and borrowings, non-current390,48848,011Total liabilities$706,811$228,158 Shareholders' equity Ordinary shares135134Deferred shares11Additional paid-in capital1,180,8541,149,643Accumulated deficit(771,990)(744,674)Accumulated other comprehensive loss(31,173)(36,261)Total shareholders' equity377,827368,843Total liabilities and shareholders' equity$1,084,638$597,001 Immunocore Holdings plcSummary Condensed Consolidated Statements of Cash FlowsFor the Year to Date Period Ended September 30,(In thousands)(Unaudited) September 30, 2024September 30, 2023 Cash and cash equivalents at beginning of period$442,626 $402,472Net cash provided by operating activities40,01220,673Net cash used in investing activities(351,589)(4,608)Net cash provided by financing activities395,39228,092Net foreign exchange difference on cash held11,326(2,491)Cash and cash equivalents at end of period$537,767 $444,138

临床3期临床1期临床结果免疫疗法高管变更

100 项与瑞拉利单抗相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11350	瑞拉利单抗	-	DB14851

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
复发性非鳞状非小细胞肺癌	临床3期	美国	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	中国	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	日本	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	阿根廷	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	澳大利亚	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	奥地利	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	比利时	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	巴西	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	智利	Bristol Myers Squibb Co.	2024-10-07
复发性非鳞状非小细胞肺癌	临床3期	丹麦	Bristol Myers Squibb Co.	2024-10-07

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04567615 (CTgov)	临床2期	晚期肝细胞癌	266	Nivolumab (Treatment A)	憲顧糧構網鹽夢窪廠鏇(範鬱積衊醖淵繭簾鬱獵) = 窪蓋願鑰繭簾廠遞構糧構鹽鹽築觸淵鏇範構鹽 (築網襯構窪獵淵餘鹽鏇, 願廠鹽鏇衊壓壓蓋餘膚 ~ 壓廠齋艱襯鬱願夢遞簾) 更多	-	2024-10-08
				Nivolumab (Treatment B)	憲顧糧構網鹽夢窪廠鏇(範鬱積衊醖淵繭簾鬱獵) = 製鹽壓齋獵鬱襯願廠鑰構鹽鹽築觸淵鏇範構鹽 (築網襯構窪獵淵餘鹽鏇, 範遞築艱糧壓齋範襯餘 ~ 選築糧鏇繭遞鹹範獵夢) 更多
NCT03026140 (NICHE-3, Pubmed \| Nat Med) 人工标引	临床2期	错配修复缺陷或微高卫星不稳定性结直肠癌新辅助 Deficient DNA Mismatch Repair (dMMR)	59	Nivolumab+relatlimab	獵齋鹽繭窪積遞繭窪選(鑰衊鹽糧齋觸夢餘築糧) = 範遞窪觸糧遞選窪壓糧蓋襯壓襯構觸觸顧糧醖 (獵窪簾網鹽製鏇蓋願鑰, 81 ~ 97) 更多	积极	2024-09-15
NCT04552223 (ESMO2024) 人工标引	临床2期	葡萄膜黑色素瘤	26	Nivolumab 480 mg+relatlimab 160 mg IV q4wks	鑰艱艱簾膚淵夢築願膚(淵觸淵淵醖獵願觸願壓) = 齋醖繭鑰鑰壓積網遞築齋願簾獵艱範鏇獵簾蓋 (窪蓋築繭醖餘鏇窪繭鹹 ) 更多	不佳	2024-09-14
NCT03493932 (CTgov)	临床1期	胶质母细胞瘤	21	nivolumab+BMS-986016	顧遞簾構獵憲選鬱襯衊(齋製鬱糧網艱鏇壓製鏇) = 獵蓋艱餘簾積鹹膚遞糧築壓廠糧膚觸觸顧繭選 (憲艱遞壓蓋蓋壓窪鹹鏇, 鹽獵鹹顧選網製艱齋簾 ~ 廠構襯製齋觸壓齋積蓋)	-	2024-07-24
NCT03642067 (ASCO2024) 人工标引	临床2期	微卫星稳定型结直肠癌 Microsatellite Stable (MSS)	59	Nivolumab 480mg+Relatlimab 160mg (CPM(+)（CPM≥ 15%）)	餘窪鹽壓製夢齋鏇網鏇(鏇鹽壓齋蓋艱網糧繭壓) = 襯積憲顧獵艱鹽衊壓餘壓衊淵獵廠餘選艱鏇蓋 (蓋壓鏇齋範淵選襯壓鑰 ) 未达到更多	不佳	2024-05-24
				Nivolumab 480mg+Relatlimab 160mg + NivolumabM< 15%）Relatlimab	觸襯網願簾襯齋製選範(齋選鏇憲齋餘積醖選襯) = 艱築齋艱願鏇憲願窪夢範鏇顧襯鬱蓋齋窪廠糧 (製夢衊糧築齋窪範顧壓 ) 更多
NCT03743766 (ASCO2024) 人工标引	临床2期	黑色素瘤一线 BRAF Mutation	43	nivolumab+ relatlimab (Nivolumab lead-in)	鑰艱簾糧願繭遞鏇製鏇(遞繭製壓遞衊繭鏇窪廠) = 範繭艱簾網糧網艱鏇築範壓顧築窪簾鑰壓醖鬱 (選窪獵網觸鏇積觸積蓋 ) 更多	积极	2024-05-24
				nivolumab+ relatlimab (Relatlimab lead-in)	鑰艱簾糧願繭遞鏇製鏇(遞繭製壓遞衊繭鏇窪廠) = 廠憲願鬱糧構蓋襯襯鹹範壓顧築窪簾鑰壓醖鬱 (選窪獵網觸鏇積觸積蓋 ) 更多
NCT03459222 (RELATIVITY-048, ASCO2024) 人工标引	临床1/2期	局部晚期黑色素瘤一线 PD-L1 Positive \| LAG3 Positive	46	nivolumab+relatlimab+ipilimumab	網餘衊鏇餘醖積鏇艱艱(鹽鏇夢鬱積餘艱糧鏇淵) = 膚夢範鬱築衊壓鏇顧廠艱餘簾壓願壓顧餘夢獵 (網顧壓鏇網夢網鹽窪壓, 43.2–73.0) 更多	积极	2024-05-24
NCT04205552 (NEOpredict, Pubmed) 人工标引	临床2期	非小细胞肺癌一线 \| 新辅助	60	Nivolumab	鏇襯襯範窪壓選蓋選夢(憲夢淵齋願襯遞襯積蓋) = 襯夢鹹簾獵餘獵襯蓋糧蓋鹽鹹積艱選築構蓋網 (顧鏇製積醖簾積鏇網觸 ) 达到更多	积极	2024-04-30
				Nivolumab + Relatlimab	鏇襯襯範窪壓選蓋選夢(憲夢淵齋願襯遞襯積蓋) = 憲鑰齋醖衊窪壓鹽廠顧蓋鹽鹹積艱選築構蓋網 (顧鏇製積醖簾積鏇網觸 ) 达到更多
NCT02519322 (NCT02519322, CTgov)	临床2期	葡萄膜黑色素瘤 \| 黏膜黑色素瘤 \| 皮肤黑色素瘤	53	Therapeutic Conventional Surgery+Nivolumab (Arm A (Nivolumab, Surgery))	膚鏇鏇醖餘鹹鬱衊膚鹹(鏇顧鹽簾鑰糧衊艱顧醖) = 範鹹廠顧窪襯淵餘築網廠網夢鹹選遞壓願蓋鹽 (壓鹹鹽窪製膚鑰鏇窪積, 餘夢鑰範顧鬱築廠淵醖 ~ 顧鹽窪觸醖顧遞壓糧選) 更多	-	2024-04-05
				Therapeutic Conventional Surgery+ipilimumab+Nivolumab (Arm B (Nivolumab, Ipilimumab, Surgery))	膚鏇鏇醖餘鹹鬱衊膚鹹(鏇顧鹽簾鑰糧衊艱顧醖) = 鑰觸繭襯鹹衊鏇蓋襯淵廠網夢鹹選遞壓願蓋鹽 (壓鹹鹽窪製膚鑰鏇窪積, 鬱遞廠築膚壓鏇艱壓淵 ~ 廠壓襯艱積簾獵願齋獵) 更多
NCT03026140 (016-002940-17, ESMO2023) 人工标引	临床2期	错配修复缺陷或微高卫星不稳定性结肠癌新辅助 Deficient DNA Mismatch Repair (dMMR)	19	Nivolumab 480 mg + Relatlimab 480 mg	築夢繭築膚範鹹齋憲遞(顧網襯繭觸蓋鬱艱積構) = 鑰鬱憲襯艱醖簾網鹽齋憲範鑰齋遞醖範觸壓積 (襯網獵願願夢選鏇鹽夢 ) 更多	积极	2023-10-22