TACTI-004, a Double-Blinded, Randomized Phase 3 Trial in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Receiving Eftilagimod Alfa (MHC Class II Agonist) in Combination With Pembrolizumab (PD-1 Antagonist) and Chemotherapy.

The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) among adults with metastatic non-small cell lung cancer (NSCLC).
Participants will receive either efti plus standard treatment (pembrolizumab and platinum doublet chemotherapy) or placebo plus standard treatment and will be treated for up to 2 years.

开始日期2025-03-21

申办/合作机构

Immutep SAS

[+1]

NCT06128863

/ Active, not recruiting临床2期IIT

Phase II, Single-arm Clinical Trial Evaluating Efficacy and Safety of Pembrolizumab in Combination with a Soluble LAG-3 Protein, Eftilagimod Alpha, and Radiotherapy in Neoadjuvant Treatment of Patients with Soft Tissue Sarcomas (EFTISARC-NEO)

This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alpha (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.

开始日期2023-07-17

申办/合作机构

Maria Sklodowska-Curie National Research Institute of Oncology

[+1]

NCT04252768

/ Withdrawn临床1期

AIPAC-002 (Active Immunotherapy PAClitaxel-002): A Multicentre, Phase Ib Study to Test a New Schedule of Eftilagimod Alpha (a Soluble LAG-3 Protein) as Adjunctive to Weekly Paclitaxel in Hormone Receptor-positive Metastatic Breast Carcinoma Patients

This is a multicentre, multinational Phase Ib study in female HR+ MBC patients not receiving Her2-targeted therapy. Treatment consists of a chemo-immunotherapy phase followed by a maintenance phase. The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 paclitaxel intravenously on Day 1, 8 and 15 and 30 mg efti subcutaneously on Day 1 and 15 in a 28-day (4-week) cycle. Efti will always be given after paclitaxel. The maintenance phase comprises 6 visits with 4 weekly intervals; during each such visit 30 mg efti is given subcutaneously as monotherapy. A total of 24 subjects will be enrolled into the study. The primary goal of the study is safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day in contrast to subsequent days as in the AIPAC trial.

开始日期2023-06-01

申办/合作机构

Immutep SAS

100 项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的临床结果

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100 项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的转化医学

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100 项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的专利（医药）

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项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的文献（医药）

2024-11-01·JTO clinical and research reports

Eftilagimod Alpha (a Soluble LAG-3 Protein) Combined With Pembrolizumab in Second-Line Metastatic NSCLC Refractory to Anti–Programmed Cell Death Protein 1/Programmed Death-Ligand 1-Based Therapy: Final Results from a Phase 2 Study

Article

作者: Roxburgh, Patricia ; Krebs, Matthew G. ; Majem, Margarita ; Clay, Tim ; Mueller, Christian ; Andres, B. ; Doger, Bernard ; Krebs, Matthew G ; Triebel, F. ; Doger, B. ; Forster, Martin ; Triebel, Frédéric ; Majem, M. ; Forster, M. ; Iams, W. ; Clay, T. ; Bajaj, P. ; Iams, Wade ; Perera, Suvini ; Peguero, J. ; Mueller, C. ; Bajaj, Pawan ; Krebs, M.G. ; Barba, Andres ; Roxburgh, P. ; Perera, S. ; Peguero, Julio

Introduction:

Eftilagimod alpha (efti), a soluble lymphocyte activation gene-3 protein, triggers antigen-presenting cell and T-cell (CD4⁺ and CD8⁺) activation and helps overcome resistance to programmed cell death protein 1 or programmed cell death-ligand 1 (PD-(L)1) inhibitors. We assessed efti plus pembrolizumab in second-line anti-PD-(L)1-refractory metastatic patients with NSCLC.

Methods:

After confirmed progression on anti-PD-(L)1-based first-line therapy, patients received efti (30 mg subcutaneously every 2 weeks for eight 3-week cycles and then every 3 weeks for up to 54 weeks) plus pembrolizumab (200 mg intravenously every 3 weeks for up to 105 weeks). The primary endpoint was the objective response rate by modified Response Evaluation Criteria in Solid Tumors version 1.1 for immune-based therapies. Secondary endpoints included disease control rate, progression-free survival, overall survival (OS), and tolerability. Exploratory endpoints included tumor growth kinetics and predefined subgroup analyses. Programmed cell death-ligand 1 tumor proportion score was assessed centrally.

Results:

Thirty-six patients were enrolled from April 2019 to August 2021 using Simon's two-stage design. Most patients (81.8%) had low or negative (<50%) PD-(L)1 tumor proportion score. First-line therapy was anti-PD-(L)1-based for all patients, combined with chemotherapy for 66.7%. The confirmed objective response and disease control rates were 8.3% and 33.3%. The median progression-free survival was 2.1 months and the median OS was 9.9 months. Patients exhibiting high PD-(L)1 expression or acquired resistance to PD-(L)1 inhibitors revealed superior response and survival outcomes, and OS was closely correlated with disease control. No treatment-emergent adverse event led to permanent discontinuation of study treatment.

Conclusions:

Efti plus pembrolizumab was well-tolerated and revealed signs of antitumor activity in patients with NSCLC resistant to PD-(L)1 inhibitors, warranting further investigation. Trial registration number: NCT03625323.

2024-09-03·CLINICAL CANCER RESEARCH

Eftilagimod Alpha (Soluble LAG3 Protein) Combined with Pembrolizumab as Second-Line Therapy for Patients with Metastatic Head and Neck Squamous Cell Carcinoma

Article

作者: Patel, Grisma ; Pousa, Antonio L. ; Roxburgh, Patricia ; Bajaj, Pawan ; Brignone, Chrystelle ; Mueller, Christian ; Krebs, Matthew ; Doger, Bernard ; Forster, Martin ; Triebel, Frederic ; Peguero, Julio ; Brana, Irene ; Carcereny, Enric

Abstract:

Purpose::

Eftilagimod alpha (efti), a soluble LAG3 protein, activates antigen-presenting cells (APC) and downstream T cells. TACTI-002 (part C) evaluated whether combining efti with pembrolizumab led to strong antitumor responses in patients with second-line recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) while demonstrating good tolerability.

Patients and Methods::

In this multinational phase II trial using Simon’s two-stage design, patients who were PD-L(1)-naïve with R/M HNSCC who had failed first-line platinum-based therapy, unselected for PD-L1, received intravenous pembrolizumab (200 mg, once every 2 weeks) combined with subcutaneous efti (30 mg once every 2 weeks for 24 weeks and once every 3 weeks thereafter). The primary endpoint was objective response rate per RECIST 1.1 modified for immune-based therapy by investigator assessment. Additional endpoints included duration of response, progression-free survival, overall survival, and tolerability. Pharmacodynamic effects (absolute lymphocyte count) and Th1 cytokine biomarkers (IFNγ/CXCL10)] were evaluated in liquid biopsies.

Results::

Between March 2019 and January 2021, 39 patients were enrolled; 37 were evaluated for response. All patients received prior chemotherapy, and 40.5% were pretreated with cetuximab; 53.1% of patients had PD-L1 combined positive score <20. With a median follow-up of 38.8 months, the objective response rate was 29.7%, including 13.5% complete responders. The median duration of response was not reached. Rapid and sustained absolute lymphocyte count increase was observed in patients who had an objective response. Th1 biomarkers increased sustainably after first treatment. No unexpected safety signals were observed.

Conclusions::

Efti plus pembrolizumab was safe and showed encouraging antitumor activity and pharmacodynamic effects in patients with second-line head and neck squamous cell carcinoma (HNSCC), thus supporting further evaluation of this combination in earlier treatment lines.

2024-02-01·Clinical cancer research : an official journal of the American Association for Cancer Research

Paclitaxel plus Eftilagimod Alpha, a Soluble LAG-3 Protein, in Metastatic, HR+ Breast Cancer: Results from AIPAC, a Randomized, Placebo Controlled Phase IIb Trial

Article

作者: Perjesi, Luca ; Dalenc, Florence ; Pápai, Zsuzsanna ; Brignone, Chrystelle ; Duhoux, Francois P. ; Armstrong, Anne ; Marme, Frederik ; Kuemmel, Sherko ; Jager, Agnes ; Dirix, Luc ; Cuypere, Eveline ; Triebel, Frederic ; Schröder, Carolina P. ; Wildiers, Hans ; Mueller, Christian ; Vuylsteke, Peter ; Menke-van der Houven van Oordt, Catharina Willemien ; Chan, Steve ; Huober, Jens ; Brain, Etienne

Abstract:

Purpose::

Eftilagimod alpha (efti), a soluble lymphocyte activation gene (LAG-3) protein and MHC class II agonist, enhances innate and adaptive immunity. Active Immunotherapy PAClitaxel (AIPAC) evaluated safety and efficacy of efti plus paclitaxel in patients with predominantly endocrine-resistant, hormone receptor–positive, HER2-negative metastatic breast cancer (ET-resistant HR+ HER2− MBC).

Patients and Methods::

Women with HR+ HER2– MBC were randomized 1:1 to weekly intravenous paclitaxel (80 mg/m2) and subcutaneous efti (30 mg) or placebo every 2 weeks for six 4-week cycles, then monthly subcutaneous efti (30 mg) or placebo maintenance. Primary endpoint was progression-free survival (PFS) by blinded independent central review. Secondary endpoints included overall survival (OS), safety/tolerability, pharmacokinetics/pharmacodynamics, and quality of life. Exploratory endpoints included cellular biomarkers.

Results::

114 patients received efti and 112 patients received placebo. Median age was 60 years (91.6% visceral disease, 84.1% ET-resistant, 44.2% with previous CDK4/6 inhibitor treatment). Median PFS at 7.3 months was similar for efti and placebo. Median OS was not significantly improved for efti (20.4 vs. 17.5 months; HR, 0.88; P = 0.197) but became significant for predefined exploratory subgroups. EORTC QLQC30-B23 global health status was sustained for efti but deteriorated for placebo. Efti increased absolute lymphocyte, monocyte and secondary target cell (CD4, CD8) counts, plasma IFNγ and CXCL10 levels.

Conclusions::

Although the primary endpoint, PFS, was not met, AIPAC confirmed expected pharmacodynamic effects and demonstrated excellent safety profile for efti. OS was not significantly improved globally (2.9-month difference), but was significantly improved in exploratory biomarker subgroups, warranting further studies to clarify efti's role in patients with ET-resistant HER2− MBC.

206

项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的新闻（医药）

2025-06-25

·BioSpace

TIGIT Turmoil: How Pharma Burned Billions on Failed Immuno-Oncology Projects

Created with Canva Dreamlab † Leading companies spent $1.4 billion upfront on licensing deals and embarked on vast R&D programs. Clinical setbacks mean many companies are unlikely to ever recoup their investments. TIGIT was once the hottest target in immuno-oncology. Just a few years later, the pipeline has thinned significantly as a who’s who of drugmakers have retreated from the mechanism in response to lackluster clinical data. Some R&D programs are ongoing, but the rapid retreat means the industry has already burnt billions of dollars on deals and development for failed candidates. Bristol Myers Squibb , Gilead, GSK and Novartis paid $1.4 billion upfront between them to join Merck and Roche in the TIGIT race. The figure excludes the $175 million Gilead paid to enter into a multi-asset deal that gave it the right to license candidates including Arcus Biosciences’ domvanalimab, but includes the $275 million the big biotech handed over when it took up its option on the anti-TIGIT antibody. The deals collectively included more than $5 billion in milestones. However, the overwhelming majority of them were unpaid when BMS, GSK and Novartis dropped their TIGIT programs. Gilead is still developing its asset and could owe Arcus up to $500 million in milestones tied to approvals in the U.S. Even without the regulatory milestones, Gilead has bet more on TIGIT than some of its peers. The outlay includes $740 million in equity investments in Arcus. Gilead paid an average of $27.58 per share across the three purchases. Arcus currently trades below $10. The fate of domvanalimab will go a long way in determining what return, if any, Gilead gets on its investment in Arcus. TIGIT Development Costs TIGIT development costs are embedded in the vast R&D budgets of the biopharma companies advancing the candidates. Roche’s broad tiragolumab development program accounted for some of the almost $15 billion the Swiss drugmaker spent on R&D last year, but publicly available figures lack details of the company’s spending on TIGIT. Similarly opaque accounts obscure TIGIT spending at other companies. Programs partnered with smaller biotechs shed some light on TIGIT development costs. GSK and iTeos Therapeutics agreed to spend $900 million on the global development plan for their TIGIT drug. The asset’s failure in Phase II means GSK and iTeos likely only spent a fraction of that amount, but the figure provides a ballpark estimate of what companies with large late-phase programs may have invested. Roche has tested tiragolumab in 10 Phase III studies with a collective enrollment target of almost 4,600 patients. Merck’s Phase III vibostolimab program spanned five studies with a collective enrollment target of more than 4,600 patients. Gilead, Arcus and AstraZeneca, which is partnered on a domvanalimab trial, have sponsored three Phase III studies that are enrolling almost 3,000 patients among them. If GSK and iTeos’ spending plan is indicative of R&D costs at other companies, Gilead, Merck and Roche may have spent billions of dollars between them taking their TIGIT assets through mid- and late-phase trials. Gilead’s relationship with Arcus provides another datapoint. Arcus received between $161 million and $165 million from its collaboration partners as reimbursement for R&D costs in 2022, 2023 and 2024. Mechanisms other than TIGIT will account for some of the spending. Equally, the figures do not capture spending on Gilead-led activities, which Arcus said increased in 2024. ITeos’ accounts provide another glimpse at the cost of TIGIT development. As of the end of March, the biotech had raised more than $1.1 billion across public and private financing rounds and its deal with GSK. ITeos, which is closing down over its TIGIT flop, had $624 million in cash and investments. The difference between the amount iTeos had raised and the amount it was holding was more than $500 million. A History of Failed Oncology Bets Spending on TIGIT adds to the mountain of money that drug developers have plowed into an alphabet soup of targets that at one time were seen as the next big thing in cancer immunotherapy. IL-2 attracted interest in 2018 and 2019, when BMS paid Nektar Therapeutics $1.85 billion to co-develop a molecule and Sanofi acquired Synthorx for $2.5 billion. Both programs ended in failure. Other companies placed bets on CD47. Gilead acquired Forty Seven for $4.9 billion in 2020 and Pfizer snapped up Trillium Therapeutics for $2.3 billion the following year. Pfizer continues to list maplirpacept, a CD47 candidate acquired in the Trillium takeover, in its pipeline, but Gilead’s travails have dampened expectations. Gilead gave up on Forty Seven’s magrolimab last year after a series of setbacks. TIM-3, 4-1BB, ICOS, OX40 and CD73 are among the other targets that have attracted heavy investment, including triple-digit upfront licensing fees, over the years. Active clinical development is continuing in some areas but the targets are yet to live up to the early excitement, such as the report that 4-1BB drug candidates were driving “pretty phenomenal responses” in cancer patients. Work on LAG-3 delivered an approved drug, BMS’ Opdualag, but sales have been fairly modest by the standards of leading immuno-oncology products. Opdualag, a fixed-dose combination of PD-1 and LAG-3 blockers, generated sales of $928 million last year. BMS is on course to reach the blockbuster threshold this year, with sales in the first quarter coming in at $252 million. As excitement about TIGIT and the other targets has faded, PD-1/L1xVEGF-A bispecifics have emerged as the industry’s next big hope. With China’s Akeso validating the mechanism, albeit without allaying concerns about overall survival and efficacy in global trials , leading biopharma companies have moved swiftly to secure riders in immuno-oncology’s new hottest race. In the nine months since Akeso’s ivonescimab beat Keytruda, BioNTech, BMS, Merck and Pfizer have paid more than $4 billion upfront among them for rights to PD-1/L1xVEGF-A bispecifics. The outlay will rise by at least $2 billion as BMS makes noncontingent payments and could top $20 billion if the deals hit their milestones. The fallout from failure would make the TIGIT turmoil look like a tempest in a teapot.

并购临床3期免疫疗法引进/卖出临床2期

2025-05-29

·GlobeNewswire-Health Care

Immutep’s Efti with Radiotherapy & KEYTRUDA® (pembrolizumab) Meets Primary Endpoint in Phase II for Soft Tissue Sarcoma

Novel combination with efti has met the trial’s primary endpoint of tumour hyalinization/fibrosis in the neoadjuvant setting for patients with resectable soft tissue sarcoma Detailed results are planned for presentation at a future medical meeting May 27, 2025 -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint. The novel combination significantly exceeded the study’s prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable soft tissue sarcoma (STS). Tumour hyalinization/fibrosis is an early surrogate endpoint at the time of surgical resection that has been associated with improved overall survival and recurrence-free survival for STS patients.1,2 The trial’s investigators at the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present detailed results from the study at a future medical meeting. Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO and the trial’s principal investigators, said: “It is very encouraging to see the chemotherapy-free combination with efti far exceed the ambitious target we initially set for the trial's primary endpoint in resectable soft tissue sarcoma. These results support our belief that efti's activation of antigen-presenting cells, and in turn a broad adaptive and innate immune response, helps transform the immunosuppressed tumour microenvironment of soft tissue sarcomas leading to strong anti-cancer efficacy. There remains a very high unmet need in this aggressive orphan cancer indication and we look forward to presenting detailed results at a medical meeting later this year.” As previously announced at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024, the combination therapy demonstrated significant efficacy with a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients with resectable STS available for primary endpoint assessment. The EFTISARC-NEO study, which is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program, subsequently completed enrolment of 40 patients in January 2025. STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.3 Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. 1. Schaefer IM et al. Histologic Appearance After Preoperative Radiation Therapy for Soft Tissue Sarcoma: Assessment of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group Response Score. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):375-383. doi: 10.1016/j.ijrobp.2017.02.087. Epub 2017 Feb 24. PMID: 28463157. 2. Rao SR et al. Extent of tumor fibrosis/hyalinization and infarction following neoadjuvant radiation therapy is associated with improved survival in patients with soft-tissue sarcoma. Cancer Med. 2022 Jan;11(1):194-206. doi: 10.1002/cam4.4428. Epub 2021 Nov 27. PMID: 34837341; PMCID: PMC8704179. 3. American Cancer Society statistics: https://www.cancer.org/cancer/types/soft-tissue-sarcoma/about/key-statistics.html The content above comes from the network. if any infringement, please contact us to modify.

临床结果免疫疗法快速通道孤儿药

2025-05-15

·GlobeNewswire-Health Care

Immutep’s Efti with KEYTRUDA® (pembrolizumab) & Chemotherapy Achieves High Response Rates in First-Line Non-Small Cell Lung Cancer

Novel combination achieves 60.8% response rate and 90.2% disease control rate in first-line non-small cell lung cancer (1L NSCLC)Notably, ~92% of all evaluable patients have PD-L1 TPS <50%, including 43% with PD-L1 below 1 (TPS <1%), who represent an area of high unmet needData demonstrates significant improvement in response rates compared to historical controls, and safety continues to be favourableMulti-centre INSIGHT-003 is evaluating the same immunotherapy/chemotherapy combination used in the pivotal TACTI-004 Phase III in 1L NSCLCAdditional data from INSIGHT-003 is planned for presentation at a medical conference later this year SYDNEY, AUSTRALIA, May 15, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces that a 60.8% response rate and 90.2% disease control rate, according to RECIST1.1, has been achieved in the investigator-initiated INSIGHT-003 trial as of the data-cut off date of 06 May 2025. INSIGHT-003 is evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC). Marc Voigt, CEO of Immutep, stated, “Our level of confidence in efti driving a new standard of care for patients with non-small cell lung cancer via our pivotal TACTI-004 trial continues to rise with the strength of the data from INSIGHT-003 and TACTI-002. Across two trials we have now efficacy data from 165 patients with 1L NSCLC who have been treated with efti and KEYTRUDA, either with or without chemotherapy. In multi-national settings, efti has generated consistent and remarkable improvements in response rates. In particular, the interim ORR data in patients with PD-L1 expression below 50% in the ongoing INSIGHT-003 trial, who represent over two-thirds of the 1L NSCLC patient population, is very encouraging.” Majority of Patients have PD-L1 TPS <50%Notably, ~92% of all evaluable patients (N=51) in the INSIGHT-003 study have PD-L1 TPS <50%. This includes 49% of patients with PD-L1 Tumour Proportion Score (TPS) of 1-49% and 43% of patients with PD-L1 TPS <1%, as shown in the table below. Strong Response Rates Across All PD-L1 Expression LevelsData from all evaluable patients demonstrates significant improvement of Overall Response Rate (ORR) according to RECIST 1.1 across all levels of PD-L1 expression compared to historical control from a registrational trial of anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC1: 75.0% ORR versus 62.1% ORR in patients with high PD-L1 expression (TPS >50%)64.0% ORR versus 49.2% ORR in patients with low PD-L1 expression (TPS 1-49%)54.5% ORR versus 32.3% ORR in patients with negative PD-L1 expression (TPS <1%) The 60.8% response rate regardless of PD-L1 expression (TPS 0-100%) represents a substantial improvement compared to historical control of 48.0%.1 The relative outperformance is particularly strong given the registrational trial has four times as many patients with high PD-L1 expression (~32% of patients versus ~8% in INSIGHT-003), who have the highest response rates. Importantly, in patients with TPS <50% (N=47), who have a high unmet need and represent over two-thirds of the 1L NSCLC patient populaton, the triple combination with efti achieved a 59.6% response rate as compared to historical control of 40.8%.1 INSIGHT-003 Overall Response Rate & Disease Control Rate, according to RECIST1.1PD-L1 Expression LevelsTPS 0-100%(N=51)TPS <1%(N=22)TPS 1-49%(N=25)TPS <50%(N=47)TPS ≥50%(N=4)ORR %60.854.564.059.675.0DCR %90.286.492.089.4100 SafetySafety continues to be favourable for the triple combination in 1L NSCLC with no new safety signals. Next StepsAdditional data updates from this trial are expected to be presented at a medical conference in 2025 and beyond. About INSIGHT-003INSIGHT-003 is an investigator-initiated study conducted by the Frankfurt Institute of Clinical Cancer Research IKF and several other German centres. It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy in front-line non-small cell lung cancer patients consisting of efti administered subcutaneously in conjunction with an existing approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and chemotherapy (carboplatin and pemetrexed) delivered intravenously. The trial will assess the safety, tolerability, and initial efficacy of the combination. About Eftilagimod Alfa (efti)Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA). About ImmutepImmutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. 1. Shirish Gadgeel et al., Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non–Small-Cell Lung Cancer. JCO 38, 1505-1517(2020). DOI:10.1200/JCO.19.03136 KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Australian Investors/Media:Catherine Strong, Sodali & Co.+61 (0)406 759 268; catherine.strong@sodali.com U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com

免疫疗法临床结果临床3期快速通道临床1期

100 项与重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白(Immutep) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
转移性非小细胞肺癌	临床3期	澳大利亚	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	比利时	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	保加利亚	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	加拿大	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	克罗地亚	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	德国	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	希腊	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	印度	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	爱尔兰	Immutep SAS	2025-03-21
转移性非小细胞肺癌	临床3期	意大利	Immutep SAS	2025-03-21

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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


NCT06128863 (EFTISARC-NEO, GlobeNewswire) 人工标引	临床2期	软组织肉瘤新辅助	40	Eftilagimod alfa (Efti) with Radiotherapy plus KEYTRUDA® (pembrolizumab)	鑰遞艱衊鏇膚鬱觸繭餘(艱網築選簾襯鏇夢淵繭) = 膚築鑰製構獵鹹糧壓範網鹹積構餘鹽膚壓衊獵 (壓願製選遞範壓鹽築鬱 ) 达到	积极	2025-05-27
NCT03252938 (INSIGHT-003, Company_Website) 人工标引	临床1期	非鳞状非小细胞肺癌一线	-	Eftilagimod alpha (Efti) + KEYTRUDA (Pembrolizumab) + Chemotherapy (PD-L1 TPS 0-100%)	夢顧艱積衊醖簾築夢淵(淵製築憲構製範鏇鬱顧) = 夢膚簾繭願蓋積膚鹽鏇顧積蓋製廠範簾齋淵繭 (餘膚鹹餘願夢積醖襯鹹 ) 更多	积极	2025-05-15
				Eftilagimod alpha (Efti) + KEYTRUDA (Pembrolizumab) + Chemotherapy (PD-L1 TPS <1%)	夢顧艱積衊醖簾築夢淵(淵製築憲構製範鏇鬱顧) = 鬱淵願鬱蓋鑰鬱憲淵獵顧積蓋製廠範簾齋淵繭 (餘膚鹹餘願夢積醖襯鹹 ) 更多
NCT04811027 (TACTI-003 \| KEYNOTE-PNC-34 \| TACTI-003 Cohort B, GlobeNewswire) 人工标引	临床2期	头颈部鳞状细胞癌 PD-L1 CPS <1	31	Eftilagimod alfa (Efti) + Pembrolizumab (PD-L1 CPS <1)	鹹餘鹹選壓窪襯遞觸夢(繭夢蓋鑰齋願選製顧製) = 網構艱構襯鬱壓窪憲鏇構鹽襯顧廠齋鹽醖蓋淵 (鹹蓋繭憲簾淵鏇鑰鹽獵 )	积极	2025-05-05
NCT03625323 (TACTI-002 \| INSIGHT-003, CTgov)	临床2期	转移性头颈部鳞状细胞癌 \| 头颈部鳞状细胞癌 \| 非小细胞肺癌 ... 更多	187	eftilagimod alpha+pembrolizumab (KEYTRUDA®) (1st Line NSCLC)	網網襯廠艱壓窪窪壓構 = 顧遞襯蓋餘獵積艱齋淵齋簾簾餘構襯蓋鑰壓鑰 (壓網願餘蓋範顧範鏇願, 簾鏇積齋蓋廠壓艱鑰鏇 ~ 淵膚醖遞積築夢醖衊獵) 更多	-	2024-12-18
				eftilagimod alpha+pembrolizumab (KEYTRUDA®) (2nd Line NSCLC)	網網襯廠艱壓窪窪壓構 = 糧繭膚夢製醖觸壓餘糧齋簾簾餘構襯蓋鑰壓鑰 (壓網願餘蓋範顧範鏇願, 鏇顧糧鹽繭襯窪簾遞醖 ~ 網範選夢襯遞憲襯蓋鬱) 更多
NCT04811027 (TACTI-003, ESMO_IO2024 \| GlobeNewswire) 人工标引	临床2期	头颈部鳞状细胞癌一线 PD-L1 Negative	31	Eftilagimod alpha (RECIST 1.1 + Cohort B)	淵醖淵鏇鑰鹹壓獵憲壓(積蓋廠廠築糧願鹽鏇醖) = 鏇獵壓齋憲窪繭壓鬱簾觸糧築餘齋鹽蓋範願衊 (鏇簾壓鏇糧範觸築選鹹, 19.2 ~ 54.6) 更多	积极	2024-12-16
				eftilagimod alpha (iRECIST + Cohort B)	淵醖淵鏇鑰鹹壓獵憲壓(積蓋廠廠築糧願鹽鏇醖) = 遞壓願襯網窪廠遞願鹽觸糧築餘齋鹽蓋範願衊 (鏇簾壓鏇糧範觸築選鹹, 21.8 ~ 57.8) 更多
NCT03625323 (Pubmed \| JTO Clin Res Rep)	临床2期	转移性非小细胞肺癌二线 PD-(L)1 tumor proportion score	36	Eftilagimod alpha + Pembrolizumab	顧遞壓範鬱衊齋醖夢憲(餘製積夢製夢窪獵夢範) = 鹹鹽壓鏇壓鏇網構襯糧構遞窪壓築壓築蓋夢鏇 (網蓋醖獵餘觸窪鏇糧餘 ) 更多	积极	2024-11-01
NCT04811027 (TACTI-003, ESMO2024) 人工标引	临床2期	头颈部肿瘤一线 PD-L1 Expression (CPS >= 1)	118	Eftilagimod Alpha + pembrolizumab	觸壓鑰鹹繭憲蓋觸齋繭(顧襯選醖衊齋衊簾積遞) = 餘積構鹹齋範醖願淵選築製遞鬱選鑰蓋選觸鹽 (繭齋壓製窪鏇積願糧範 ) 更多	积极	2024-09-15
				Pembrolizumab	觸壓鑰鹹繭憲蓋觸齋繭(顧襯選醖衊齋衊簾積遞) = 願窪餘獵艱選鹽餘鬱製築製遞鬱選鑰蓋選觸鹽 (繭齋壓製窪鏇積願糧範 ) 更多
NCT04811027 (TACTI-003, Company_Website) 人工标引	临床2期	头颈部鳞状细胞癌一线	138	Eftilagimod alfa (Efti) + KEYTRUDA (PD-L1 Expression (CPS >20))	顧築壓鹹鑰襯窪構醖積(選膚製簾鹹鬱網構構鏇) = 餘蓋廠築廠艱觸壓艱糧壓積製製廠簾夢襯夢觸 (蓋夢蓋壓選壓衊構顧繭 ) 更多	积极	2024-06-27
				Eftilagimod alfa (Efti) + KEYTRUDA (PD-L1 Expression (CPS 1-19))	顧築壓鹹鑰襯窪構醖積(選膚製簾鹹鬱網構構鏇) = 鬱餘簾餘選範憲壓醖鹹壓積製製廠簾夢襯夢觸 (蓋夢蓋壓選壓衊構顧繭 )
NCT05747794 (AIPAC-003, ESMO_BC 12024 \| ESMO_BC 22024) 人工标引	临床2/3期	转移性乳腺癌 HER2 Negative \| Hormone Receptor Positive	6	eftilagimod alpha+paclitaxel	積觸壓顧鬱簾衊鹽糧獵(餘範夢繭願淵鹽構廠壓) = none 鹹製遞蓋廠築糧繭襯夢 (蓋膚鑰壓鏇繭網鏇窪鹽 ) 更多	积极	2024-05-16
NCT05747794 (AIPAC-003, Biospace) 人工标引	临床2/3期	转移性乳腺癌	6	Eftilagimod alpha 90 mg s.c.	繭齋觸廠範製糧遞鹽築(遞淵鑰觸觸顧鏇觸窪顧) = None 選夢遞壓艱顧構襯憲積 (齋顧鬱鑰鑰構觸壓憲鹽 ) 更多	积极	2024-05-15