This study investigates whether a single subcutaneous administration of anti-PD-1 antibody can induce CD8+ T-cell tumor-infiltration that can be non-invasively monitored with [89Zr]crefmirlimab berdoxam PET imaging as an imaging biomarker.

开始日期2025-02-01

申办/合作机构

Radboud University Medical Center

[+3]

CTIS2024-511358-36-00

/ Recruiting临床2期IIT

Selective Bladder-Sparing Trial with Sasanlimab as Maintenance Treatment Based On Clinical Response To Neoadjuvant Treatment In Molecularly Categorized Muscle Invasive Bladder Cancer Patients - ?HM-87884561

开始日期2024-12-20

申办/合作机构-

NCT06704724

/ Recruiting临床1期

A Phase 1 Open-Label Study of PF-07985045 as A Single-Agent and in Combination With Other Anti-Cancer Agents in Participants With Advanced Solid Tumors

The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.
This study also aims to find the best amount of study medication.
This study is seeking participants who have solid tumors (a mass of abnormal cells that forms a lump or growth in the body) that:
* are advanced (cancer that doesn't disappear or stay away with treatment) and
* have a KRAS gene mutation (a change in the DNA of the KRAS gene that can cause cells to grow in very high numbers).
This includes (but limited to) the following cancer types:
* Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body.
* Colorectal Cancer (CRC): This is a disease where cells in the colon (a part of large intestine) or rectum grow out of control.
* Pancreatic ductal adenocarcinoma (PDAC): This is a cancer that starts in the ducts of the pancreas but can spread quickly to other parts of the body. Pancreas is a long, flat gland that lies in the abdomen behind the stomach. Pancreas creates enzymes that help with digestion. It also makes hormones that can help control your blood sugar levels.
All participants in this study will take the study medication (PF-07985045) as pill by mouth once a day. This will be repeated for 21-day or 28-day cycles.
Depending on which part of the study participants are enrolled into they will receive the study medication (PF-07985045 alone or in combination with other anti-cancer medications). These anti-cancer medications will be given in the study clinic by intravenous (IV) that is directly injected into the veins at different times (depending on the treatment) during the 21-day or 28-day cycle.
Participants can continue to take the study medication (PF-07985045) and the combination anti-cancer therapy until their cancer is no longer responding.
The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective.
Participants will be in this study for up to 4 years. During this time, the participants will come into the clinic for 1 to 4 times in each 21-day or 28-day cycle. After the participants have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing

开始日期2024-12-10

申办/合作机构

Pfizer Inc.

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100 项与萨善利单抗相关的专利（医药）

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项与萨善利单抗相关的文献（医药）

2024-05-01·Future oncology (London, England)

CREST: phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer

Article

作者: Shore, Neal D ; Hu, Hailong ; Kretkowski, Michal ; Saltzstein, Daniel ; Pierce, Kristen J ; Redorta, Joan Palou ; Galsky, Matthew D ; Ku, Ja Hyeon ; Randall, Alison E ; Vermette, Jennifer J ; Tarazi, Jamal C ; Steinberg, Gary D ; Powles, Thomas B ; Penkov, Konstantin ; Bedke, Jens

Bacillus Calmette-Guérin (BCG) is the standard of care for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). BCG in combination with programmed cell death-1 (PD-1) inhibitors may yield greater anti-tumor activity compared with either agent alone. CREST is a phase III study evaluating the efficacy and safety of the subcutaneous PD-1 inhibitor sasanlimab in combination with BCG for patients with BCG-naive high-risk NMIBC. Eligible participants are randomized to receive sasanlimab plus BCG (induction ± maintenance) or BCG alone for up to 25 cycles within 12 weeks of TURBT. The primary outcome is event-free survival. Secondary outcomes include additional efficacy end points and safety. The target sample size is around 1000 participants.

2024-01-01·Therapeutic Advances in Medical Oncology

Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies

Article

作者: Saenko, Daria Viktorovna ; Pavlov, Dmitri ; Hirohashi, Tomoko ; Bondarenko, Igor ; Cho, Byoung Chul ; Kowalski, Karey ; Ursol, Grygorii Mykolaiovych ; Davis, Craig ; Boyko, Vasyl ; Fadeeva, Natalya Vladimirovna ; Kislov, Nikolay Viktorovich ; Hotko, Yevhen Stepanovych ; Guo, Jun ; Kulyaba, Yaroslav ; Shen, Chia-I ; Michelon, Elisabete ; Ahn, Hee Kyung ; Gong, Yi ; Yamamoto, Noboru ; Penkov, Konstantin

Background::

Sasanlimab (PF-06801591), a humanized immunoglobulin G4 monoclonal antibody, binds to programmed cell death protein-1 (PD-1), preventing ligand (PD-L1) interaction.

Objectives::

To evaluate pharmacokinetics (PK), safety, tolerability, and efficacy of two subcutaneous sasanlimab dosing regimens.

Design::

An open-label study consisting of phases Ib and II. Phase Ib: non-randomized, dose escalation, and expansion study in Asian participants with advanced malignancies.

Phase II::

conducted globally in participants with non-small-cell lung cancer with PD-L1 positive or PD-L1 status unknown tumors; participants were randomized 1:2 to receive subcutaneous sasanlimab 300 mg once every 4 weeks (300 mg-Q4W) or 600 mg once every 6 weeks (600 mg-Q6W).

Methods::

Primary endpoint in phase Ib: dose-limiting toxicity (DLT) occurring in first treatment cycle; in phase II: Ctrough and AUC.

Results::

A total of 155 participants (phase Ib, n = 34; phase II, n = 121) received sasanlimab. Phase Ib: no DLT reported. Phase II: ratio of adjusted geometric mean for AUCtau was 231.2 (90% CI, 190.1–281.2) and Ctrough was 111.5 (90% CI, 86.3–144.0) following 600 mg-Q6W (test) versus 300 mg-Q4W (reference). Phase Ib: grade 3 treatment-related adverse events (TRAEs) occurred in 1/4 (25%) and 3/12 (25%) participants treated in 300 mg-Q4W dose escalation and expansion cohorts, respectively. Phase II: grade 3 TRAEs occurred in 3/41 (7.3%) and 3/80 (3.8%) participants treated with 300 mg-Q4W and 600 mg-Q6W, respectively; no grade 4/5 TRAEs. Phase II: confirmed objective response was observed in 11/41 (26.8% (95% CI, 14.2–42.9)) and 12/80 (15.0% (95% CI, 8.0–24.7)) participants treated with 300 mg-Q4W and 600 mg-Q6W, respectively.

Conclusions::

Phase Ib regimens were considered safe with no DLTs reported. In phase II, 600 mg-Q6W regimen criteria were met for AUCtau and Ctrough metrics to support PK-based extrapolation of efficacy of alternative regimen. Regimens were well tolerated, showing anti-tumor activity in participants with advanced solid tumors. Administration of sasanlimab at a dose of 600 mg-Q6W subcutaneously may serve as a convenient alternative to 300 mg-Q4W administration.

Trial registration::

NCT04181788 (ClinicalTrials.gov); 2019-003818-14 (EudraCT).

2023-08-01·ESMO open

A phase Ib/II dose expansion study of subcutaneous sasanlimab in patients with locally advanced or metastatic non-small-cell lung cancer and urothelial carcinoma

Article

作者: Grilley-Olson, J E ; Li, M ; Cho, B C ; Odintsova, S ; Korożan, M E ; Braiteh, F ; Bonato, V ; Osipov, M ; Pikiel, J ; Yang, W ; Ribas, A ; Lugowska, I ; Damore, M A ; Kurochkin, A ; Bowers, M ; Penkov, K ; Jacobs, I A ; Johnson, M L ; Bondarenko, I ; Ahn, H K

BACKGROUND:

Sasanlimab is an antibody to the programmed cell death protein 1 receptor. We report updated data of subcutaneous sasanlimab in non-small-cell lung cancer (NSCLC) and urothelial carcinoma dose expansion cohorts from a first-in-human phase Ib/II study.

PATIENTS AND METHODS:

Patients were ≥18 years of age with NSCLC or urothelial carcinoma, and no prior immunotherapies, who progressed on or were intolerant to systemic therapy, or for whom systemic therapy was refused or unavailable. Patients received subcutaneous sasanlimab at 300 mg every 4 weeks (q4w). Primary objectives were to evaluate safety, tolerability, and clinical efficacy by objective response rate (ORR).

RESULTS:

Sixty-eight and 38 patients with NSCLC and urothelial carcinoma, respectively, received subcutaneous sasanlimab. Overall, sasanlimab was well tolerated; 13.2% of patients experienced grade ≥3 treatment-related adverse events. Confirmed ORR was 16.4% and 18.4% in the NSCLC and urothelial carcinoma cohorts, respectively. ORR was generally higher in patients with high programmed death-ligand 1 (PD-L1) expression (≥25%) and high tumor mutational burden (TMB; >75%). In the NSCLC and urothelial carcinoma cohorts, median progression-free survival (PFS) was 3.7 and 2.9 months, respectively; corresponding median overall survival (OS) was 14.7 and 10.9 months. Overall, longer median PFS and OS correlated with high PD-L1 expression and high TMB. Longer median PFS and OS were also associated with T-cell inflamed gene signature in the urothelial carcinoma cohort.

CONCLUSIONS:

Subcutaneous sasanlimab at 300 mg q4w was well tolerated with promising clinical efficacy observed. Phase II and III clinical trials of sasanlimab are ongoing to validate clinical benefit. Subcutaneous sasanlimab may be a potential treatment option for patients with NSCLC or urothelial carcinoma.

项与萨善利单抗相关的新闻（医药）

2025-03-06

·PRNewswire

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准免疫疗法优先审批

2025-02-26

·抗体圈

一次宇宙级合作

去年哪家美股biotech风头最盛，候选者里一定有Summit（SMMT）的名字。如今，summit在发布2024年财报的同时，再度传出了令人联想甚多的公告：Summit将会把其从康方引进的依沃西单抗（AK112）与辉瑞的ADC药物进行联用，共同开展接下来的临床试验，并且在公告中，对ADC的用词是“several”，即依沃西单抗将要与辉瑞的多种ADC进行联用。结合BioNTech前段时间研发日发布的战略布局，这不禁让从业者与投资者进行猜想：是否依沃西单抗将会成为辉瑞接下来肿瘤治疗中的backbone drug，在化疗到ADC的迭代中发挥中流砥柱的作用。更进一步，目前辉瑞的临床试验联用，是否是之后收购summit的前奏曲？毕竟辉瑞在新冠时期接到的泼天富贵，还远远没有用完。 01 辉瑞目前的困境众所周知，宇宙药厂辉瑞在新冠期间靠疫苗和特效药发了横财，并且在2024年，它都是制药业务板块营收最高的MNC。但顶峰意味着危机感。从辉瑞的肿瘤药业务来看，虽然2024年辉瑞整个肿瘤板块的营收达到了156.12亿美元，并且2024年的增速也非常可观，达到了25%，是辉瑞三大板块中增速最强的板块。但是从大单品的营收占比可以看到，辉瑞目前主导肿瘤板块的单品仍然是小分子。排名第一的是派柏西利，治疗乳腺癌的CDK4/6抑制剂，小分子爆款单品的代表，排名第二的是恩杂鲁胺，治疗前列腺癌的抗雄激素受体小分子。排名第三和第四是两款ADC药物，这才轮到大分子，并且第三和第四两款ADC单品营收相加也才26亿美元。（图片来源：辉瑞2024年财报）辉瑞的肿瘤营收板块，很长一段时间都是靠派柏西利这款小分子重磅炸弹撑起来的。而如今，这款药物也到了危急关头：就在2024年，派柏西利的营收额被礼来的阿贝西利反超。CDK4/6抑制剂是肿瘤药物最卷的领域之一，迭代速度就是如此之快。靠小分子药物撑起肿瘤板块的辉瑞也在尽其所能破局，其中最大的动作就是收购seagen——ADC领域的代表性先驱，通过收购seagen，辉瑞不仅获得了Padev等爆款单品，也获得了诸多的ADC在研管线。但无论怎么看，总会觉得作为最大MNC之一的辉瑞，在肿瘤板块缺了一块拼图，这块拼图，就是免疫疗法——化疗之后癌症治疗新的基石。辉瑞的PD-1进展相对于其它MNC而言已经形成了代差，其PD-1单抗——Sasanlimab目前刚完成III期临床试验，并且做的癌种也仅仅是膀胱癌，除此之外，在clinical trial网站上关于它的临床试验非常之少，仅有的临床试验也都处在临床I期阶段。该PD-1单抗似乎目前仅仅垂直于膀胱癌去开发，目前仅有的优势是剂型——皮下注射。那么辉瑞是否有关于PD-1的双抗，其实并不是没有。从官网可以看到，它有一款靶向PD-1和IL-12的双抗——PF-07921585，不过该双抗起步非常晚，其临床I期试验2024年底才开始，主要终点预计要在2028年达成。从辉瑞股价的周K来看，其近一年来也总体呈现下跌趋势，原因在于之前新冠疫苗和特效药预期的出清，目前缺乏突破上限的带来想象力的题材。而收购了seagen之后，ADC作为化疗的迭代者，但ADC想构成想象力，似乎还缺了一条腿，而这条腿就是下一代的免疫检查点抑制剂，可以作为肿瘤治疗中backbone的管线，但辉瑞目前似乎还没有太多自身进行开发的行动。从这一角度出发，辉瑞与summit的依沃西双抗联用，成为了顺理成章的事情。 02 Summit与AK112 AK112（依沃西单抗），在海外又叫作SMT112，它是目前为止summit唯一正在推进的管线。从昨日披露的Summit年报PPT来看，好消息是其临床III期试验HARMONi将会在2025年中旬读出III期临床结果。当时康方和summit在2022年12月达成了BD交易，而HARMONi随之在2023年5月开始进行，本来预计主要终点在今年12月达到，但目前来看要比计划预期更快。这里对summit手中的三个III期临床试验进行区分，它们分别是HARMONi，HARMONi-3和HARMONi-7。 HARMONi对标国内的临床试验是HARMON-A，即去年最先读出临床数据的试验，HR达到了惊人的0.46，患者基线非常差的情况下做出了显著的临床获益。HARMONi同样是与化疗联用，用来治疗后线的EGFR TKI治疗后耐药的患者。从临床试验官网上招募的情况来看，HARMONi试验在北美或者欧洲地区，招募的将会是第三代TKI治疗后出现进展的患者。 HARMONi将会成为今年summit最重要的一个催化，除此之外，今年康方的HARMON-A临床OS数据对summit也影响非常之大。如果说Harmoni是临床III期中的“前锋”，那么HARMONi-3和HARMONi-7则是临床III期中的主力了。前者的临床预期注册人数为420人，而后面两个试验的预期注册人数分别为1080和780人。 HARMONi-3的开始时间同样为2023年，但预计达到主要终点的时间为2027年。该临床可以看作HARMONi-2试验国外复刻版本中的一部分——一线治疗NSCLC，与K药进行头对头比较。而HARMONi-7则是HARMONi-2试验国外复刻版本中的另一部分。它在今年年初开始，预期2028年4月到达主要终点。它同样是一线治疗NSCLC，与K药头对头比较，差异之处在于对PD-L1表达水平有限制，招募的是高表达（TPS＞50%）的患者。 Summit的管线布局以及适应症目前来看非常单一化，这无可厚非，杜根的目的也就是将Summit打包高价卖出，预期之内是只要NSCLC做出了临床结果，那么BD就成为顺理成章的事情，至于SMT112在海外的其它癌种适应症拓展，就是买下它的MNC的事情了。 03 收购与否两种可能从昨天美股的市场反映来看，summit大跌，似乎不尽如人意，但笔者这里对summit的态度是乐观的。目前辉瑞的下一代ADC去与SMT112进行联用是好事情，从上限来说，这是收购的开端；从下限来说，summit目前价格高昂，或许最终收购不是那么顺利，但summit联用ADC拓展了它的想象力，对其进行下一步融资，进一步BD管线将会起到至关重要的作用。先说上限。正如前文所述，辉瑞在收购seagen之后，获得了多条ADC在研管线，但是在如今，手握ADC权益的MNC和准MNC纷纷在想办法引进AK112同靶点的双抗，最典型的就是BioNTech，在引进映恩和宜联的数条管线后引进PM8002，并且最后将普米斯收购，而默沙东即便拥有K药的情况下，也未雨绸缪，BD了礼新医药的LM-299，用来与其手中的大量ADC管线进行联用。在这样的情况下，辉瑞自然也在进行谋划，目前的联用策略可以看做是辉瑞的谨慎考虑，这其中的主要原因是summit的价格过高，换句话说，summit目前的质地是否值得目前的市值？在harmoni都还没有出顶线数据的情况下，毕竟康方的数据只能代表中国人数据，而FDA申报非常重视白人患者的数据。在没有一个确定的III期临床试验成功的情况下，summit是否值得目前的市值？这需要打一个大大的问号。在笔者看来，辉瑞的这次联用的谨慎考虑，主要考虑的正是目前的性价比问题，即summit还看不到临床III期的确定性：在白人人种中的确定性。如果最后有了足够的确定性，收购不是没有可能。而下限来说，summit最终因为价格过高并没有被收购，手握SMT112的它将要自身完成多瘤种适应症的拓展，手握这条管线在，便是握着first in class的想象力，大大有助于其融资。这里说一个反直觉的事实，summit在2024年R&D费用大幅度增加，从2023年的6000万美元左右大幅度增加到了2024年的1.5亿美元，但是summit的库存现金是在变多的状态，其库存现金从2023年底的1.86亿美元增长到了2024年底的4.12亿美元。并且总负债从1.25亿美元下降到了4680万美元。这恰恰说明了对于目前的summit而言，融资是一件容易的事情，summit并不好缺少流动资金，导致其做不完III期临床就现金流枯竭。下限方面，哪怕是让summit自身做完III期临床进行商业化，这家公司的潜力，也不会差，只是这样的话，就是这家公司大概率会走vertex或者百济神州的道路，靠一到两个大单品实现爆发成为biopharma。之后，大概率就是继续license in管线了。而昨日的大跌某种程度上，是summit在高位之后，弹簧绷得太紧，一点小小的风吹草动带来了基本面的过度反应。长期来看，这次联用解读成利好是没问题的。这点上，今天康方就是大涨的状态，笔者认为是这次联用再次证明了AK112的价值，其价值被MNC认可，此外还有就是未来里程碑费用付款的确定性增加。而里程碑费用，羊毛出在羊身上，出在summit身上，summit有钱，做得成功，康方才能付款。因此，昨天的过激反应反倒是对summit一次情绪上的出清，价值上的重构。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

并购财报抗体药物偶联物疫苗临床3期

2025-02-24

·BioPharmaDive

Summit partners with Pfizer to study bispecific, ADC combinations

Dive Brief:Summit Therapeutics and Pfizer on Monday said they will test an experimental Summit immunotherapy with Pfizers antibody drug conjugates in trials evaluating two of the sectors most closely watched types of cancer medicines.Pfizer will oversee the clinical trials, which will involve Summits ivonescimab and multiple different Pfizer ADCs against certain solid tumors. The two companies will retain commercialization rights to their respective products, Summit said.According to Summit, the deal will allow us to quickly advance beyond our promising late-stage development plan, which already includes multiple studies in lung cancer. The companies didnt provide specifics, but said the trials will begin in the middle of the year and aim to find potentially landscape-changing combinations.Dive Insight:Ivonescimab simultaneously binds two well-studied cancer drug targets called PD-1 and VEGF.Summit licensed the medicine from China-based Akesoin 2022 and, since then, has reported results showing the treatment bested Merck & Co.s Keytruda in a Phase 3 lung cancer trial.The surprise results made drugs like ivonescimab, known as PD-1/VEGF inhibitors, among the most sought after in cancer research.Several drug companies, Merck & Co.among them, have since cut deals to acquire or license such drugs, even as important questions about their benefits have yet to be answered.Summit has a trio of late-stage trials underway in lung cancer, including one that tests ivonescimab and chemotherapy against the Keytruda-chemo combination thats standard treatment for most lung cancer cases. The company is exploring its potential elsewhere, too, and the deal announced Monday helps Summit do that while evaluating ivonescimab alongside some of the most innovative ADCs from Pfizer, said co-CEOs Bob Duggan and Maky Zanganeh, in a statement.For Pfizer, the deal provides a window into a potential immunotherapy advance. The company largely missed out on the earlier wave of checkpoint inhibitor drugs, first partnering and then abandoning a collaboration with Merck KGaA on Bavenciobefore turning to a newer prospect called sasanlimab. But its invested heavily in other types of cancer drugs, most notably ADCs through its $43 billion acquisition of Seagen. That investment gave the company the ADCs its now using in the Summit deal.This collaboration represents the next wave of investigational targeted combinations with the potential to transform treatment options for people living with cancer, said Pfizer oncology early stage development head Megan OMeara, in a statement.Pfizer acquired three marketed ADCs Adcetris, Padcev and Tivdak when it acquired Seagen. But it also has some other ADCs in its cancer drug pipeline.Shares in Summit fell by double digits in trading Monday. '

并购免疫疗法临床3期抗体药物偶联物

100 项与萨善利单抗相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	临床3期	美国	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	中国	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	日本	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	澳大利亚	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	比利时	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	加拿大	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	法国	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	德国	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	意大利	Pfizer Inc.	2019-12-30
非肌层浸润性膀胱肿瘤	临床3期	波兰	Pfizer Inc.	2019-12-30

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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


NCT04165317 (CREST, NEWS) 人工标引	临床3期	非肌层浸润性膀胱肿瘤	-	sasanlimab + standard-of-care Bacillus Calmette-Guérin	廠選顧顧繭鹹壓築選醖(鬱簾醖鏇網構糧鏇餘範) = CREST met its primary endpoint. 鬱繭積繭積獵範製醖鹽 (願衊積網廠構淵鹽衊蓋 ) 达到更多	积极	2025-01-10
				standard-of-care Bacillus Calmette-Guérin
NCT04181788 (2019-003818-14, Pubmed \| Ther Adv Med Oncol)	临床2期	肺癌 PD-L1 positive	155	Sasanlimab 300 mg-Q4W	衊構艱遞遞網夢遞窪繭(蓋醖衊簾淵製獵鹽網繭) = 網憲膚蓋窪衊繭鏇淵獵糧網積顧夢襯糧鹹鬱繭 (壓糧遞繭獵鏇築窪餘簾, 14.2 ~ 42.9)	积极	2024-01-01
				Sasanlimab 600 mg-Q6W	衊構艱遞遞網夢遞窪繭(蓋醖衊簾淵製獵鹽網繭) = 繭範壓淵積襯築鹹顧範糧網積顧夢襯糧鹹鬱繭 (壓糧遞繭獵鏇築窪餘簾, 8.0 ~ 24.7)
NCT04181788 (2019-003818-14, CTgov)	临床2期	非小细胞肺癌 \| 晚期癌症	155	PF-06801591 (Phase 1b Escalation 300 mg SC Q4W)	築製淵獵壓鹹製遞鏇網(鬱觸製膚憲壓衊齋鏇顧) = 遞憲網範蓋獵鹽鹹鬱窪齋觸壓淵鬱鹹廠夢製艱 (繭鬱艱餘遞鬱構製簾醖, 獵衊壓築艱鹽壓網餘顧 ~ 鹽膚築窪醖齋選範鑰齋) 更多	-	2023-05-08
				PF-06801591 (Phase 1b Expansion 300 mg SC Q4W)	築製淵獵壓鹹製遞鏇網(鬱觸製膚憲壓衊齋鏇顧) = 醖糧鹽憲製鹹鬱蓋窪製齋觸壓淵鬱鹹廠夢製艱 (繭鬱艱餘遞鬱構製簾醖, 繭積淵選觸蓋願願選衊 ~ 襯襯鏇衊網窪醖鑰願範) 更多
NCT02573259 (ESMO2020)	临床1期	转移性非小细胞肺癌 \| 尿路上皮癌	106	SC PF-06801591 300mg q4w	獵廠積簾範糧糧積窪鹹(顧顧積鏇膚簾醖選構觸) = 獵築糧構廠鬱蓋壓觸獵獵選顧構憲願網淵繭簾 (窪糧衊夢鬱積簾鑰艱醖 ) 更多	积极	2020-09-17
NCT02573259 (AACR2020)	临床1期	转移性非小细胞肺癌 \| 尿路上皮癌	106	PF-06801591 300 mg	衊糧鹹獵廠憲壓醖鹽憲(鬱遞願廠顧糧鹽糧壓衊) = 夢餘膚艱築糧顧鬱觸鹹廠糧餘選襯網壓選構範 (窪憲糧遞選夢鹽醖齋獵 )	积极	2020-08-15
NCT02573259 (ESMO2019)	临床1期	转移性非小细胞肺癌 \| 尿路上皮癌	106	SC PF-06801591 300mg q4w	獵衊鹹鹽壓窪醖鬱範構(鹽積積鏇選淵夢膚衊觸) = 4.7% 鑰艱網壓製鏇膚餘積壓 (鏇衊蓋網顧獵壓繭獵鹹 ) 更多	积极	2019-09-30
NCT02573259 (Pubmed \| JAMA Oncol) 人工标引	临床1期	实体瘤	40	PF-06801591 (intravenously)	憲艱糧獵鏇觸蓋淵鹽鏇(範襯餘餘淵艱蓋網壓蓋) = No dose-limiting toxic effects were observed. 鏇膚齋艱壓鹹構醖築顧 (壓遞築築壓顧願壓繭衊 )	积极	2019-07-01
				PF-06801591 (subcutaneously)