A Phase Ib/II Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Efficacy Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma

This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study.

开始日期2024-12-27

申办/合作机构

University of Texas Health Science Center At San Antonio

[+1]

NCT05469178

/ Terminated临床1/2期

Phase 1b/2a Safety and Tolerability Study of Bemcentinib With Pembrolizumab/Carboplatin/Pemetrexed in Subjects With Untreated Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Without/With a STK11 Mutation

The primary purpose of this study is to determine the safety and tolerability of the combination of bemcentinib with chemo-immunotherapy (CIT) to identify the recommended phase 2 dose (RP2D) when administered as first line (1L) treatment in participants with locally advanced (Stage IIIb/IIIC) or metastatic (Stage IV) non-squamous NSCLC with no actionable mutations and to determine the anti-tumor activity of the combination of bemcentinib with CIT when administered as 1L treatment in participants with locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) non-squamous NSCLC with serine/threonine kinase 11 (STK11) mutation and no actionable mutations.

开始日期2023-03-06

申办/合作机构

BerGenBio ASA

CTIS2022-500363-12-00

/ Not yet recruiting临床2期IIT

Efficacy and Safety of AXL-Inhibitor bemcentinib for the Treatment of Moderate COVID-19 (AXL-SolidAct) - AXL-SolidAct

开始日期2022-09-27

申办/合作机构-

100 项与 Bemcentinib 相关的临床结果

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100 项与 Bemcentinib 相关的转化医学

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100 项与 Bemcentinib 相关的专利（医药）

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215

项与 Bemcentinib 相关的文献（医药）

2026-02-01·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Phytochemicals as potential AXL inhibitors for cancer therapy: A computational study

Article

作者: Elasbali, Abdelbaset Mohamed ; Alharethi, Salem Hussain ; Elayyan, Afnan Elayyan Mousa ; Mohammad, Taj ; Hassan, Md Imtaiyaz

The TAM (Tyro3, AXL, and Mer) receptor tyrosine kinases play vital roles in immunity and various complex diseases, particularly cancer. In this family, AXL has stood out as a promising target for therapeutic development due to its significant role in cancer progression and resistance to therapies. AXL and its ligand GAS6 promote metastasis and therapeutic resistance in several human cancers. Dysregulated AXL signaling is implicated in a spectrum of diseases, notably metastatic cancer. Elevated AXL expression correlates with drug resistance and poor survival in multiple cancers such as lung, breast, pancreatic, ovarian, colon, and melanoma. In this study, we conducted a virtual screening of phytochemicals sourced from the IMPPAT 2.0 database of Indian medicinal plants to identify potential AXL inhibitors. Preliminary screening was performed based on the physicochemical properties of the phytochemicals, followed by their interaction studies in molecular docking with AXL. Of 17,908 phytochemicals initially screened, 11,676 drug-like compounds complied with Lipinski's rule-of-five and were subjected to molecular docking and downstream analyses. Subsequent evaluation included ADMET analysis, PAINS examination, and PASS analysis to identify potent hits against AXL. From this screening, Neogitogenin and Solaspigenin emerged as promising candidates demonstrating favorable drug-like properties and significant binding potential with the AXL binding pocket. Neogitogenin and Solaspigenin showed binding affinities of -10.1 to -10.8 kcal/mol, favorable ADMET profiles, and with RMSD values ranging between 0.32 and 0.38 nm, indicating stable binding. Furthermore, molecular dynamics simulation over 200 ns revealed stable protein-ligand complexes with some minor conformational fluctuations. This study suggests that, after further experimentation, modulating AXL with natural compounds holds promise for combating human malignancies, potentially overcoming limitations of existing synthetic inhibitors such as R428.

2025-10-01·BIOCHEMICAL PHARMACOLOGY

AXL enhances the self-renewal of cancer stem-like cells and Osimertinib chemoresistance by regulating SCD1 in non-small cell lung cancer

Article

作者: Pan, Qianrong ; Lin, Zhongxiao ; Yang, Xiangyu ; Lin, Fangqin ; Lei, Xueping ; Chen, Zhuowen ; Yu, Xiyong ; Huang, Wei ; Ke, Yuanyu ; Liu, Jieyao ; Deng, Quidi

Non-small cell lung cancer (NSCLC) is one of the most common malignant tumors characterized with high incidence and mortality rate. Although many therapeutic agents have been applied for NSCLC therapy. However, majority patients inevitably suffer from chemoresistance after a period of therapy. Cancer stem-like cells (CSCs) are a critical factor for the chemoresistance in NSCLC. AXL is a member of the TAM family and its abnormal expression has been observed in NSCLC. Whereas, its role in the self-renewal of CSCs and Osimertinib resistance is still largely unknown. In this study, we showed that AXL was critical for the self-renewal ability of CSCs. AXL overexpression obviously promoted the self-renewal ability of CSCs and attenuated NSCLC cells sensitivity to Osimertinib. Whereas, AXL knockdown showed opposite effect. We also showed that AXL promoted CSCs properties partly dependent on stearoyl-CoA desaturase 1 (SCD1). SCD1 silence suppressed the CSCs properties of PC9^{AXL vector} and NCI-H292^{AXL vector} cells and increased their sensitivity to Osimertinib. SCD1 overexpression showed opposite effect on NCI-H460^shAXL and NCI-H1299^shAXL cells. Further research revealed that AXL might promoted SCD1 expression by up-regulating SREBP1, a critical transcription factor of SCD1. Moreover, targeting AXL with R428 significantly suppressed the self-renewal ability of CSCs and increased their sensitivity to Osimertinib. Taken these together, our study provides new insight into the role and mechanism of AXL in regulating NSCLC CSCs stemness. Our study also gives a new hint for the relationship between AXL and SCD1.

2025-03-13·ACS Medicinal Chemistry Letters

A Hybrid Energy-Based and AI-Based Screening Approach for the Discovery of Novel Inhibitors of AXL

Article

作者: Zhao, Jingyi ; Pan, Youlu ; Ying, Xiaojun ; Li, Long ; Lv, Xinting ; Huang, Wenhai ; Wang, Linjun ; Chi, Xinglong ; Pan, Zhichao ; Kang, Youkun

AXL, part of the TAM receptor tyrosine kinase family, plays a significant role in the growth and survival of various tissues and tumors, making it a critical target for cancer therapy. This study introduces a novel high-throughput virtual screening (HTVS) methodology that merges an AI-enhanced graph neural network, PLANET, with a geometric deep learning algorithm, DeepDock. Using this approach, we identified potent AXL inhibitors from our database. Notably, compound 9, with an IC₅₀ of 9.378 nM, showed excellent inhibitory activity, suggesting its potential as a candidate for further research. We also performed molecular dynamics simulations to explore the interactions between compound 9 and AXL, providing insights for future enhancements. This hybrid screening method proves effective in finding promising AXL inhibitors, and advancing the development of new cancer therapies.

项与 Bemcentinib 相关的新闻（医药）

2025-07-01

·FierceBiotech

BerGenBio, in wake of lead cancer drug\'s failure, opts to merge with radiopharma Oncoinvent

Oslo-based Oncoinvent\'s lead radiopharma is in phase 2 trials.\n BerGenBio, reeling from the failure of its lead cancer drug, has opted to merge with fellow Norwegian cancer biotech Oncoinvent.The deal will see Oncoinvent’s shareholders own 75% of the merged company, with BerGenBio’s shareholders owning the remaining 25%. The resulting entity, which will operate under the Oncoinvent brand, will be focused on Oncoinvent’s lead radiopharma asset Radspherin.BerGenBio, which is based in Bergen, Norway, put its decision to go ahead with the merger in the context of the discontinuation in February of the biotech’s AXL kinase inhibitor bemcentinib. The company blamed a lack of responses in a phase 2 study of the lead candidate in non-small cell lung cancer and said at the time that it would now consider its strategic options—including a potential merger or sale.“This merger, which is backed by the boards of both companies, is the result of an extensive review that explored a range of strategic options for BerGenBio,” Anders Tullgren, chair of BerGenBio’s board, said in a June 30 postmarket release.“The merger gives BerGenBio shareholders a part of an exciting company leveraging Norwegian radiopharmaceutical technology, which has already seen encouraging preliminary efficacy data, without safety concerns,” Tullgren added. “We are confident that this is the best option for current BerGenBio shareholders.”The merger values BerGenBio at 65 million Norwegian kroner ($6.5 million) and Oncoinvent at 195.5 million kroner ($19.4 million).The deal will provide an additional 45 million kroner ($4.5 million) to fund Oncoinvent\'s clinical development plan, which is headed up by Radspherin, an alpha-emitting radionuclide radium-224 being tested in peritoneal cancer in patients who have had surgery for colorectal or ovarian cancers.Radspherin is currently being evaluated in a phase 2 trial across the U.S., UK and Europe with a readout penciled in for the second half of 2026. So far, preliminary efficacy data have been “highly encouraging,” Oncoinvent said in the release.The plan once the merger is completed is for a fully underwritten rights issue of 130 million kroner ($12.9 million), which should pave a cash runway past that readout and into 2027.“We are very excited for the time ahead and to continue the execution of our focused strategy to develop Radspherin in ovarian cancer,” Oncoinvent CEO Øystein Soug said in the release.“We are on track with our randomised phase 2 trial,” Soug added. “Going forward with a strengthened balance sheet, we believe the company will be a transformative force in the radiopharmaceutical therapy field, improving the lives of patients with cancer in the peritoneal cavity.”Oslo-based Oncoinvent was founded by Øyvind Bruland, M.D., Ph.D., and Roy Larsen, Ph.D., the pioneers behind Xofigo, a prostate cancer radiopharma drug that was acquired by Bayer in 2014 as part of its acquisition of Algeta.

$BerGenBio, in wake of lead cancer drug\'s failure, opts to merge with radiopharma Oncoinvent$

临床2期并购

2025-04-17

·智药邦

Science｜复旦大学郁金泰团队发现帕金森病全新治疗靶点，并利用AI找到潜在治疗药物

帕金森病（Parkinson’s Disease，PD），是一种影响运动和认知功能的神经退行性疾病，也是世界上第二常见的神经退行性疾病，仅次于阿尔茨海默病（AD），影响着约 1%-2%的65岁及以上老人。随着全球人口老龄化，帕金森病患病率还将大幅增加。病理性α-突触核蛋白（α-Syn）在不同脑区聚集介导了帕金森病的疾病进展。聚集的α-Syn蛋白形成纤维，以朊病毒样（Prion-like）方式发挥作用，在大脑的不同区域传播α-Syn病理，然而，其在神经元之间传递的分子机制，目前仍不清楚。之前的研究显示，α-Syn通过不同受体的内吞作用被内化，然而，其在神经元上的特异性受体仍有待完全鉴定。郁金泰团队曾于2020年10月在Science Advances期刊发表论文，首次发现了FAM171A2基因的单核苷酸多态性（rs708384）与帕金森病等神经退行性疾病的风险增加有关。帕金森病患者的脑脊液（CSF）中FAM171A2蛋白水平增加，并且与脑内α-Syn高聚集的指征相关。2025年2月20日，复旦大学附属华山医院郁金泰教授团队联合复旦大学脑科学转化研究院袁鹏教授及中国科学院上海有机化学研究所刘聪教授（博士后吴凯敏为第一作者），在国际顶尖学术期刊Science上发表了题为：Neuronal FAM171A2 mediates α-synuclein fibril uptake and drives Parkinson’s disease的研究论文。该研究首次发现了帕金森病（PD）的全新治疗靶点——FAM171A2，并利用基于人工智能的蛋白质结构预测和虚拟筛选技术，成功找到了具有潜在治疗作用的小分子化合物。这项研究发现的全新治疗靶点和前在治疗药物有望从疾病早期对帕金森病进行干预，延缓疾病进展，结合现有的对症治疗手段，有望实现帕金森病病因治疗与症状缓解的双重突破。在这项最新研究中，研究团队通过对超过100万样本的大规模全基因组关联分析（GWAS），发现FAM171A2基因的5个突变（例如rs850738、rs708384）与帕金森病风险显著相关。帕金森病患者的脑脊液（CSF）中FAM171A2蛋白水平升高，且与α-Syn病理标志物呈负相关，提示其参与了α-Syn的异常聚集。进一步实验验证显示，过表达FAM171A2会促进α-Syn纤维的被神经元内吞，加剧病理扩散（例如向黑质、纹状体的扩散）和运动功能障碍。而敲低FAM171A2能够减少α-Syn纤维的内吞，保护多巴胺能神经元，从而改善小鼠的运动表现。研究团队在小鼠神经元中特异性敲除FAM171A2，进一步验证了神经元来源的FAM171A2在α-Syn病理传播中是必要的。从机制上来说，FAM171A2蛋白的胞外结构域1通过静电力与α-Syn的C端相互作用，且高度选择性地结合病理性α-Syn（纤维形式），其对纤维形式α-Syn的选择性结合是单体形式α-Syn的超1000倍。也就是说，位于神经元上的FAM171A2蛋白能够高度选择性的结合病理性α-Syn，使其通过内吞作用进入神经元内，诱导神经元内的正常的单体形式的α-Syn发生错误折叠，转变为病理性α-Syn，进而诱导神经元死亡以及在神经元之间传播。接下来，研究团队使用AlphaFold-Multitimer预测了FAM171A2-α-Syn复合物结构，并利用虚拟筛选技术，从7173种化合物中筛选出了一种小分子药物——Bemcentinib，其能够竞争性结合α-Syn的C端，从而阻断FAM171A2与病理性α-Syn结合，抑制FAM171A2介导的神经元对病理性α-Syn的内吞。总的来说，该研究首次阐明了FAM171A2作为病理性α-Syn的神经元受体，揭示了其驱动帕金森病病理传播的分子机制，并成功筛选到了潜在抑制剂，为帕金森病的精准治疗提供了新方向。未来研究可聚焦于靶向FAM171A2的药物开发及多维度验证其临床价值。相关阅读：2024年11月22日，复旦大学附属华山医院郁金泰、毛颖团队与复旦大学类脑智能科学与技术研究院程炜、冯建峰团队合作，在国际顶尖学术期刊Cell在线发表了题为：Atlas of the plasma proteome in health and disease in 53,026 adults的研究论文。这项研究全面绘制了人类健康与疾病蛋白质组图谱，并结合人工智能大数据分析方法，构建了疾病诊断预测模型以及发现了26个药物治疗新靶点，为精准医学的实施提供了重要科学依据。该研究于2025年1月9日，登上了Cell期刊封面，该封面描绘了一个由蛋白质构成的人类，正在借助人工智能（由芯片和二进制代码代表）的帮助来检查自己的健康状况（通过心电图监测界面来体现）。参考资料：1.https://www-science-org.libproxy1.nus.edu.sg/doi/10.1126/sciadv.abb30632.https://www-science-org.libproxy1.nus.edu.sg/doi/10.1126/science.adp36453.https://www-cell-com.libproxy1.nus.edu.sg/cell/fulltext/S0092-8674(24)01268-6--------- End ---------感兴趣的读者，可以添加小邦微信加入读者实名讨论微信群。添加时请主动注明姓名-企业-职位/岗位或姓名-学校-职务/研究方向。

申请上市临床研究

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

100 项与 Bemcentinib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11438	Bemcentinib	-	DB12411

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
转移性非鳞状非小细胞肺癌	临床2期	美国	BerGenBio ASA	2023-03-06
转移性非鳞状非小细胞肺癌	临床2期	法国	BerGenBio ASA	2023-03-06
转移性非鳞状非小细胞肺癌	临床2期	希腊	BerGenBio ASA	2023-03-06
转移性非鳞状非小细胞肺癌	临床2期	匈牙利	BerGenBio ASA	2023-03-06
转移性非鳞状非小细胞肺癌	临床2期	意大利	BerGenBio ASA	2023-03-06
转移性非鳞状非小细胞肺癌	临床2期	波兰	BerGenBio ASA	2023-03-06
转移性非鳞状非小细胞肺癌	临床2期	西班牙	BerGenBio ASA	2023-03-06
新型冠状病毒感染	临床2期	印度	BerGenBio ASA	2020-10-20
新型冠状病毒感染	临床2期	南非	BerGenBio ASA	2020-10-20
转移性胰腺癌	临床2期	美国	BerGenBio ASA	2019-01-03

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临床结果

适应症

分期

评价

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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


NCT03184571 (BGBC008, AACR2025)	临床2期	难治性肺癌 granzyme B \| cDC1 \| phospho-STAT3	29	Bemcentinib + Pembrolizumab	範選廠蓋壓艱膚鑰顧築(築顧繭築願壓構廠鹹淵) = 憲鏇願餘積鬱鑰餘鑰鏇齋糧艱憲衊醖淵鏇積蓋 (夢顧鏇網鹹餘憲築選網 )	积极	2025-04-30
				Bemcentinib (AXL-PD1-STAT3 axis)	範選廠蓋壓艱膚鑰顧築(築顧繭築願壓構廠鹹淵) = 積衊鏇窪獵憲夢壓壓範齋糧艱憲衊醖淵鏇積蓋 (夢顧鏇網鹹餘憲築選網 )
NCT02424617 (CTgov)	临床1/2期	非小细胞肺癌	40	Bemcentinib (Phase 1- Run in Arm (Bemcentinib Monotherapy))	獵選製鹽糧範襯獵窪鑰 = 觸願築構鏇醖夢糧選願鹹築鏇顧壓醖憲鏇鏇選 (蓋壓願糧蓋繭築鬱壓膚, 齋選窪鬱憲獵鹽壓鹹襯 ~ 窪獵淵醖鹽齋鹽艱鹹鑰) 更多	-	2025-02-26
				Erlotinib+Bemcentinib (Phase 1- Arm A (Bemcentinib + Erlotinib))	獵選製鹽糧範襯獵窪鑰 = 願餘繭膚衊構齋遞繭壓鹹築鏇顧壓醖憲鏇鏇選 (蓋壓願糧蓋繭築鬱壓膚, 襯觸夢積餘範衊齋築淵 ~ 襯繭顧鏇壓壓遞餘衊選) 更多
NCT06469138 (8479217, CTgov)	临床1期	急性髓性白血病 \| 新型冠状病毒感染 \| 恶性间皮瘤 ... 更多	6	Bemcentinib	築獵鹽蓋遞積遞鹹廠積(艱構艱憲遞網蓋淵廠鑰) = 糧鑰艱餘憲鹹衊夢艱壓觸餘鬱廠蓋製觸鑰選鏇 (淵構齋願選糧夢廠餘夢, 26.8) 更多	-	2025-01-29
NCT04890509 (CTgov)	临床2期	新型冠状病毒感染	115	SOC	廠壓網糧襯憲觸餘窪蓋(襯窪鹹遞艱蓋製壓艱構) = 鹽蓋窪獵鑰鏇鑰鑰鑰顧鹽壓構鏇鹹廠艱願選顧 (衊醖獵艱鹽糧簾繭願構, 鹽願構鹹壓襯鑰廠艱獵 ~ 膚積範願選選願膚艱餘) 更多	-	2024-10-16
NCT02488408 (BGBC003, ASH2023)	临床1/2期	急性髓性白血病	32	Bemcentinib + Low-dose Cytarabine	築簾廠積廠鹽獵鬱製膚(淵淵廠築願簾齋憲製繭) = 網餘選艱鏇範選廠範簾構鏇膚繭製鬱網淵鹹衊 (艱繭繭鏇繭膚膚遞壓鏇 ) 更多	-	2023-12-09
NCT03649321 (CTgov)	临床1/2期	转移性胰腺癌	9	Nab-paclitaxel+gemcitabine+cisplatin+Bemcentinib (Phase 1b)	鹹顧蓋繭構積繭壓獵範 = 遞壓觸鹽膚積窪積鹽醖築繭壓積衊餘觸鹽艱窪 (夢襯積憲糧顧繭繭窪衊, 齋鹹範壓製蓋蓋鏇壓網 ~ 鏇鑰憲選窪顧製鏇繭餘) 更多	-	2023-11-09
				Nab-paclitaxel+Gemcitabine+Bemcentinib (Phase 2)	鹹顧蓋繭構積繭壓獵範 = 觸積鹹餘築顧繭膚糧衊築繭壓積衊餘觸鹽艱窪 (夢襯積憲糧顧繭繭窪衊, 繭醖淵繭餘糧願選簾艱 ~ 願鑰廠構選齋鑰齋築淵) 更多
NCT03184571 (BGBC008, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	非小细胞肺癌二线	99	Bemcentinib + Pembrolizumab	夢繭齋壓鹹膚壓廠鏇鹽(淵壓鑰簾醖顧獵獵簾選) = 鏇鑰餘繭衊構鏇糧壓範遞獵壓窪窪艱鏇艱鑰簾 (構鹽醖鬱蓋選構夢遞淵 ) 更多	积极	2023-10-23
				Bemcentinib + Pembrolizumab (AXL TPS > 5)	夢繭齋壓鹹膚壓廠鏇鹽(淵壓鑰簾醖顧獵獵簾選) = 壓鹽艱顧糧願範築鑰範遞獵壓窪窪艱鏇艱鑰簾 (構鹽醖鬱蓋選構夢遞淵 ) 更多
NCT02872259 (BGBIL006, ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	转移性黑色素瘤	68	Bemcentinib+PembrolizumabPem or D/TDabrafenibTrametinib (Bemcentinib+Pembrolizumab or Dabrafenib/Trametinib)	積淵顧齋鏇鬱鑰鏇憲觸(廠餘鏇願遞壓廠淵遞衊) = 願憲築鑰築觸蓋繭鏇遞遞積艱憲願淵醖蓋築觸 (醖鹽構窪繭範網齋觸築 ) 更多	不佳	2023-10-21
				PembrolizumabPem or D/TDabrafenibTrametinib (Pembrolizumab or Dabrafenib/Trametinib)	-
NCT03654833 (MiST3, ASCO 12023 \| ASCO 22023) 人工标引	临床2期	间皮瘤	26	Pembrolizumab+Bemcentinib	艱鹹壓鹹醖網衊襯憲網(淵製鑰艱衊鹹齋構選網) = 窪衊淵構衊鬱憲鹹網襯顧膚積壓鹹鏇鹹繭獵簾 (憲醖範獵顧鹹衊獵範餘, 29.2 ~ 63.4) 更多	积极	2023-05-26
NCT02922777 (ASCO2022) 人工标引	临床1期	非小细胞肺癌一线	21	Docetaxel+Bemcentinib	餘鬱鏇壓範窪構築築憲(蓋糧鹹網鑰鹹鏇鹹蓋鹹) = 60 mg/m2 docetaxel plus 200 mg bemcentinib daily 繭簾衊製壓選獵簾窪壓 (觸鏇醖鹹範構網糧衊網 ) 更多	积极	2022-06-02