The Efficacy of Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery: a Study Protocol for a Prospective, Open-label ,Multi-center, Randomized, Controlled Trial in China

The purpose of this study is to explore the effects of Vebreltinib in primary glioblastoma patients receiving a combination therapy of chemotherapy (temozolomidel) and MET-TKI.

开始日期2025-01-13

申办/合作机构

复旦大学附属华山医院

[+2]

NCT06644313

/ Not yet recruiting临床2期IIT

Vebreltinib for Neoadjuvant in MET-altered Stage IIIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

According to the 2024 edition of the NCCN guidelines and the 2023 edition of the CSCO guidelines, perioperative treatment is recommended for patients with stage IIIA and IIIB (T3N2) non-small cell lung cancer (NSCLC). Targeted therapies for NSCLC, such as EGFR inhibitors and ALK inhibitors, have been explored in the neoadjuvant setting. For patients with MET alterations, some have undergone preoperative MET inhibitor treatment, achieving pathological downstaging followed by surgery, resulting in R0 resection. Therefore, this is a prospective, cohort, single-center phase II clinical study to evaluate the efficacy and safety of Vebreltinib as a neoadjuvant treatment for patients with MET-altered stage IIIA-IIIB (N2) NSCLC.

开始日期2024-11-01

申办/合作机构

上海市肺科医院

NCT06739395

/ Recruiting临床2期IIT

A Pan-Cancer Basket, Real World, Open-label, Multicenter Study on Molecular Matching Therapy Guided by Molecular Tumor Boards (MTB) for Pan Solid Tumor Patients With Standard Treatment Exhaustion

The main purpose of this study is to explore the feasibility of selecting treatment plans based on genomic variations guided by MTB in patients with advanced refractory solid tumors.

开始日期2024-11-01

申办/合作机构

天津医科大学第二医院

100 项与伯瑞替尼相关的临床结果

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100 项与伯瑞替尼相关的转化医学

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100 项与伯瑞替尼相关的专利（医药）

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项与伯瑞替尼相关的文献（医药）

2024-11-01·JOURNAL OF CLINICAL ONCOLOGY

Vebreltinib for Advanced Non–Small Cell Lung Cancer Harboring c-Met Exon 14 Skipping Mutation: A Multicenter, Single-Arm, Phase II KUNPENG Study

Article

作者: Wang, Zhe-Hai ; Yao, Yu ; Cheng, Ying ; Hu, Jie ; Zhang, Wei ; Yang, Jin-Ji ; Chen, Yuan ; Xue, Wei-Zhe ; Shi, He-Peng ; Wu, Lin ; Chen, Jing-Hua ; Zhang, Pei-Long ; Fan, Yun ; Li, Xing-Ya ; Zhao, Jun ; Wang, Qi-Ming ; Song, Yong ; Han, Di ; Wu, Yi-Long ; Zhang, Yan ; Guo, Ren-Hua ; Lin, Gen ; Fang, Jian

PURPOSE:

The KUNPENG study aimed to evaluate the efficacy and safety of vebreltinib (also known as bozitinib, APL-101, PLB-1001, and CBT-101), a potent and highly selective inhibitor of c-mesenchymal-epithelial transition ( MET ), in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring c-Met alterations.

METHODS:

This multicenter, multicohort, open-label, single-arm, phase II trial enrolled patients with c-Met dysregulated, locally advanced or metastatic NSCLC from January 2020 to August 2022 across 17 centers. Cohort 1 included patients with MET exon 14 skipping ( MET ex14)–mutant NSCLC who had not previously received MET inhibitors. Participants were administered vebreltinib at a dosage of 200 mg twice a day in 28-day cycles. The primary end point was the objective response rate (ORR), and the key secondary end point was the duration of response (DoR), both evaluated by a blinded independent review committee according to the RECIST version 1.1.

RESULTS:

As of August 9, 2022, 52 patients had been enrolled in cohort 1, of whom 35 (67.3%) were treatment-naïve. The ORR reached 75% (95% CI, 61.1 to 86). Among treatment-naïve patients, the ORR was 77.1% (95% CI, 59.9 to 89.6), and in previously treated patients, it was 70.6% (95% CI, 44.0 to 89.7). The disease control rate was 96.2%, with a median DoR of 15.9 months, a median progression-free survival of 14.1 months, and a median overall survival of 20.7 months. The most common treatment-related adverse events were peripheral edema (82.7%), QT prolongation (30.8%), and elevated serum creatinine (28.8%).

CONCLUSION:

Vebreltinib has shown promising efficacy and a favorable safety profile in patients with MET ex14-mutant NSCLC.

2023-07-14·Chinese neurosurgical journal

PTPRZ1-METFUsion GENe (ZM-FUGEN) trial: study protocol for a multicentric, randomized, open-label phase II/III trial.

Article

作者: Li, Shouwei ; Wang, Liang ; Zhang, Bisi ; Bao, Zhaoshi ; Qiu, Xiaoguang ; Jiang, Tao ; Zhang, Peilong ; Shi, Hepeng

BACKGROUND:

PTPRZ1-MET fusion was reported to associate with glioma progression from low-grade to high-grade glioma, which was a target by a MET inhibitor vebreltinib. However, little is known about the further efficacy of vebreltinib among more glioma patients. This trial aims to evaluate the safety and efficacy of vebreltinib enteric-coated capsules in the treatment of sGBM/IDH mutant glioblastoma patients with the ZM fusion gene.

METHODS:

This multicentric, randomized, open-label, controlled trial plans to include 19 neurosurgical centers and recruit 84 sGBM or IDH mutant glioblastoma patients with the ZM fusion gene. This trial enrolls sGBM or IDH mutant glioblastoma patients with the inclusion criteria and without the exclusion criteria. It was registered with chinadrugtrials.org.cn (CTR20181664). The primary efficacy endpoint is overall survival (OS). The secondary endpoints are progression-free survival (PFS) and objective response rate (ORR).

DISCUSSION:

If proven effective, this targeted multifaceted intervention protocol will be extended for more glioma patients as a protocol to evaluate the safety and efficacy of MET inhibitors.

TRIAL REGISTRATION:

It was registered with chinadrugtrials.org.cn (CTR20181664).

2022-12-31·Journal of enzyme inhibition and medicinal chemistry2区 · 医学

Angiogenesis and anti-leukaemia activity of novel indole derivatives as potent colchicine binding site inhibitors

2区 · 医学

ArticleOA

作者: Yang, Longhua ; Huang, Tao ; Wang, Longfei ; Wang, Yuyang ; Duan, Yongtao ; Feng, Siqi ; Cheng, Weyland ; Yao, Yongfang

The screened compound DYT-1 from our in-house library was taken as a lead (inhibiting tubulin polymerisation: IC₅₀=25.6 µM, anti-angiogenesis in Zebrafish: IC₅₀=38.4 µM, anti-proliferation against K562 and Jurkat: IC₅₀=6.2 and 7.9 µM, respectively). Further investigation of medicinal chemistry conditions yielded compound 29e (inhibiting tubulin polymerisation: IC₅₀=4.8 µM and anti-angiogenesis in Zebrafish: IC₅₀=3.6 µM) based on tubulin and zebrafish assays, which displayed noteworthily nanomolar potency against a variety of leukaemia cell lines (IC₅₀= 0.09-1.22 µM), especially K562 cells where apoptosis was induced. Molecular docking, molecular dynamics (MD) simulation, radioligand binding assay and cellular microtubule networks disruption results showed that 29e stably binds to the tubulin colchicine site. 29e significantly inhibited HUVEC tube formation, migration and invasion in vitro. Anti-angiogenesis in vivo was confirmed by zebrafish xenograft. 29e also prominently blocked K562 cell proliferation and metastasis in blood vessels and surrounding tissues of the zebrafish xenograft model. Together with promising physicochemical property and metabolic stability, 29e could be considered an effective anti-angiogenesis and -leukaemia drug candidate that binds to the tubulin colchicine site.

193

项与伯瑞替尼相关的新闻（医药）

2025-03-22

·肿瘤界

Nature Medicine | 吴一龙教授揭示非小细胞肺癌患者术后监测MRD的临床价值

点击蓝字关注我们 2025年3月17日，广东省人民医院吴一龙教授、美国耶鲁大学Roy S. Herbst共同通讯在Nature Medicine（IF=58.7）在线发表题为“Molecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB–IIIA non-small-cell lung cancer”的研究论文，该研究报告了EGFR突变IB–IIIA期非小细胞肺癌（NSCLC）切除后奥希替尼辅助治疗的分子残留病（MRD）分析结果。结果表明术后MRD检测或可预测辅助治疗期间及停药后的疾病复发，以及识别潜在受益于奥希替尼长期辅助治疗的患者。奥希替尼（Osimertinib）是第三代EGFR-TKI，在早期和晚期EGFR突变（Ex19del/L858R）NSCLC中显示出疗效。根据3期ADAURA试验结果，推荐IB-IIIA期EGFR突变NSCLC患者术后接受3年奥希替尼辅助治疗。ADAURA初步分析显示，无论是否接受过化疗，奥希替尼辅助治疗较安慰剂显著（统计学/临床意义）改善IB-IIIA期EGFR突变NSCLC完全切除术后的DFS。延长2年随访的更新分析中，DFS获益持续存在，并转化为总生存率（OS）的显著改善：奥希替尼组5年OS率为88%，安慰剂组为78%，死亡HR=0.49（95.03%CI: 0.34-0.70，P<0.001）。完成3年奥希替尼治疗后DFS率有上升趋势，提示延长奥希替尼治疗时间或可进一步改善部分患者结局，但如何筛选此类患者仍不明确。根治性治疗后的标准监测模式包括连续影像学检查，但该方法仅能检测宏观病灶，且易受治疗后正常组织变化干扰，并且监测的最佳扫描频率也不确定。循环肿瘤DNA（ctDNA）可通过液体活检（如血浆）检测到，是评估肿瘤负荷和基因组改变的一种微创诊断工具。MRD（即根治性治疗后监测ctDNA）或可作为早期复发的生物标志物，具有指导治疗和预后的潜力。由于患者疾病早期肿瘤负荷低且ctDNA比例低，因此ctDNA的检测可能具有挑战性。第二代测序（NGS）技术的进步提高了ctDNA检测灵敏度，使得基于肿瘤分子特征的个性化MRD检测更具可行性。该技术利用患者肿瘤基因组谱，纵向追踪血浆ctDNA中的个体化肿瘤特异性改变。几项针对接受根治性治疗的早期NSCLC患者的研究支持使用基于肿瘤分子特征的MRD检测预测影像学复发。针对I-III期NSCLC患者的研究，例如一项纳入261例患者的前瞻性研究和一项纳入88例患者的LUCID研究显示，MRD检测较影像学识别疾病进展分别提前中位3.4个月和212.5天（约7个月）。在一项纳入40例I-III期NSCLC患者（接受放疗、化疗和/或手术）的回顾性分析中，72%患者的ctDNA检测较影像学识别疾病进展提前中位5.2个月。尽管研究有限，但这些数据提示基于肿瘤分子特征的MRD检测在早期NSCLC中的潜在应用价值。本研究对ADAURA试验中的220例患者（奥希替尼组n=112；安慰剂组n=108）进行探索性分析，探讨基于血浆与肿瘤分子特征的MRD检测能否预测辅助治疗期间及停药后的疾病复发，并探究治疗前肿瘤基因组改变与分子及临床结局的关联。本文报道了一项EGFR突变NSCLC患者术后长期纵向MRD分析结果的3期随机临床试验。 MRD分析集中患者血浆样本的纵向MRD分析本研究中，MRD检测较影像学检测复发的中位提前时间为4.7个月（95%CI：2.2-5.6）。36个月时，奥希替尼组与安慰剂组MRD阴性的DFS率分别为86% vs 36%（HR=0.23，95%CI: 0.15-0.36）。奥希替尼组中，28例（25%）患者检测到复发或MRD阳性；其中68%（19/28）发生于停药后，58%（11/19）发生于停药后12个月内。停药24个月后MRD阴性DFS率为66%。两组中多数患者检测到MRD阳性早于复发。辅助治疗期间及治疗后随访中，大部分患者维持DFS和MRD阴性，多数MRD阳性或复发发生于停药或完成治疗后。研究结果显示，MRD检测或可识别从延长奥希替尼辅助治疗中获益的患者，但需临床验证。综上所述，这项针对ADAURA试验患者的探索性分析表明，基于血浆及肿瘤分子特征MRD分析或可预测辅助治疗期间及停药后的疾病复发。研究还发现，大多数患者在奥希替尼辅助治疗期间及停药后24个月内维持无复发。这些观察结果提示，MRD监测或可指导临床干预（如重启或强化治疗）。但在将其常规应用于真实临床实践前，需开展前瞻性研究以明确辅助治疗完成后MRD监测的最佳频率及检测到MRD阳性后的适宜临床干预措施。推荐阅读 ● Nature Medicine | 吴一龙教授团队揭示脑脊液ctDNA于CNS转移瘤的重要临床价值 ● JCO丨吴一龙团队发表Vebreltinib治疗c-MET外显子14跳跃突变型非小细胞肺癌研究结果 ● 吴一龙团队新成果荣登《JAMA Oncology》首创晚期肺癌药物假期模式 ● NEJM | 吴一龙领衔全球研究，有望改写ALK阳性非小细胞肺癌辅助治疗声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。编辑：lagertha 审核：松月、南星

临床3期临床结果信使RNA

2025-03-07

·肿瘤界

Nature Medicine | 吴一龙教授团队揭示脑脊液ctDNA于CNS转移瘤的重要临床价值

点击蓝字关注我们近年来，脑脊液（CSF）的液体活检已成为非小细胞肺癌（NSCLC）脑转移诊断的重要手段之一1。中枢神经系统（CNS）肿瘤受血脑屏障影响，患者血浆中循环肿瘤DNA（ctDNA）水平往往非常低，此时CSF具有独特优势。此外，CSF中固有的核酸酶活性比全血、血浆样本更低，游离核酸稳定性更好，能反映患者长期肿瘤负荷，同时也可随着肿瘤进展呈现出波动。在CNS限制性疾病的患者中，ctDNA的突变等位基因频率显着高于血浆，体细胞突变的检测敏感性也更高，凸显出脑脊液ctDNA在CNS肿瘤中得天独厚的价值 2。 2025年2月27日，广东省人民医院吴一龙教授在nature medicine（IF=58.7）发表了题为“Cerebrospinal fluid circulating tumor DNA profiling for risk stratification and matched treatment of central nervous system metastases”的研究3。该研究证实了CSF ctDNA在反映CNS转移瘤负荷及作为独立预后生物标志物中的临床价值。近年来，NSCLC伴CNS转移[包括脑转移（BMs）和软脑膜转移（LMs）]的发病率不断上升。此外，由于CNS转移患者的临床结局高度异质，许多患者会出现CNS进展和早期死亡，因此对其的治疗管理仍然充满挑战。脑肿瘤采样的困难和风险限制了对其独特分子特征和生物标志物的了解。液体活检作为一种非侵入性检测方法，其出现为肿瘤的早期诊断和预后提供了新思路。其中，CSF ctDNA在LMs的辅助诊断以及CNS肿瘤的分子特征分析方面优于血浆ctDNA。然而，关于CSF ctDNA在临床应用方面仍有许多问题尚待解答：血浆ctDNA可反映颅外肿瘤负荷和生物学特征这一认知促使了超灵敏ctDNA检测的发展。但CNS转移中CSF ctDNA检测的决定因素仍不明确。当前BMs和LMs的风险模型需在前瞻性研究中验证。有必要采用新的方法对CNS转移进行风险分层，如CSF ctDNA。此外，CSF ctDNA匹配的治疗方案是否可行，以及能否带来生存获益仍有待探索。在少量样本中观察到脑肿瘤组织与CSF之间分子特征一致性，但CSF基因组特征与定义CNS疾病所需的临床病理特征之间的关系尚未被报道。本研究旨在全面分析584例NSCLC伴CNS转移患者的CSF及其临床病理、影像学数据和长期随访记录，以：(1) 确定CSF ctDNA与CNS转移瘤负荷的关系；(2) 明确CSF ctDNA的独立预后价值，并建立临床和CSF ctDNA特征模型以改善患者风险分层；(3) 分析患者从CSF匹配治疗策略和连续CSF监测中的获益。研究设计 CSF ctDNA预后模型研究结果显示，与CSF ctDNA阴性相比，CSF ctDNA阳性与更短的生存时间独立相关（HR=1.9，95%CI 1.56–2.39；P<0.0001）。肿瘤-CSF匹配分析确定了与不良预后相关的CSF特有分子特征（HR=1.64，95%CI 1.15–2.32，P=0.006）。研究开发了一个整合CSF ctDNA特征和临床因素的多维度CSF ctDNA预后模型，用于CNS转移的风险分层，并在独立队列中验证。在治疗史可获得的患者中，CSF ctDNA检测到驱动基因阳性的患者从CSF匹配治疗中显示出生存获益（HR=0.78，95%CI 0.65–0.92，P=0.003）。通过CSF纵向监测发现了CNS特异性耐药机制，且二次匹配的靶向治疗显示出生存期改善（HR=0.56，95%CI 0.35–0.91，P=0.018）。研究证实了CSF ctDNA在反映CNS转移瘤负荷及作为独立预后生物标志物中的临床价值。联合临床特征和CSF ctDNA指标可改善患者风险分层。此外，患者通过纵向采样从CSF匹配治疗和疾病监测中获益。因此，研究强调需将CSF ctDNA检测纳入临床实践和未来临床试验。推荐阅读 ● JCO丨吴一龙团队发表Vebreltinib治疗c-MET外显子14跳跃突变型非小细胞肺癌研究结果 ● 吴一龙团队新成果荣登《JAMA Oncology》首创晚期肺癌药物假期模式 ● NEJM | 吴一龙领衔全球研究，有望改写ALK阳性非小细胞肺癌辅助治疗声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。参考文献： 1. 中国医药教育协会肺癌医学教育专业委员会, 北京医学奖励基金会肺癌医学青年专家委员会脑转移协作组. 中国驱动基因阳性非小细胞肺癌脑转移临床诊疗指南（2025版）[J]. 中国肺癌杂志, 2025, 28(1):1-21. 2. 董柳, 关明. 脑脊液ctDNA检测在中枢神经系统肿瘤的临床应用[J] . 中华检验医学杂志, 2020, 43(11): 1128-1133. 3. Zheng MM, Zhou Q, Chen HJ, et al. Cerebrospinal fluid circulating tumor DNA profiling for risk stratification and matched treatment of central nervous system metastases. Nat Med. 2025 Feb 27. 编辑：lagertha 审核：松月

临床研究申请上市

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 项与伯瑞替尼相关的药物交易

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
IDH突变星形细胞瘤	中国	北京浦润奥生物科技有限责任公司	2024-04-17
胶质母细胞瘤	中国	北京浦润奥生物科技有限责任公司	2024-04-17
MET外显子14跳变的非小细胞肺癌	中国	北京浦润奥生物科技有限责任公司	2023-11-14

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适应症	最高研发状态	国家/地区	公司	日期
MET基因扩增非小细胞肺癌	申请上市	中国	北京浦润奥生物科技有限责任公司	2024-12-26
非鳞状非小细胞肺癌	临床3期	中国	北京浦润奥生物科技有限责任公司	2025-03-25
局部晚期非小细胞肺癌	临床2期	中国	北京鞍石生物科技股份有限公司	2024-08-07
EGFR突变的非小细胞肺癌	临床2期	美国	Apollomics, Inc. (United States)	2022-01-18
转移性非小细胞肺癌	临床2期	美国	Apollomics, Inc. (United States)	2022-01-18
晚期非小细胞肺癌	临床2期	中国	北京浦润奥生物科技有限责任公司	2020-01-17
c-Met阳性非小细胞肺癌	临床2期	中国	北京浦润奥生物科技有限责任公司	2020-01-06
肝细胞癌	临床2期	澳大利亚	Apollomics (Australia) Pty Ltd.	2018-09-05
肝细胞癌	临床2期	新西兰	Apollomics (Australia) Pty Ltd.	2018-09-05
肾细胞癌	临床2期	澳大利亚	Apollomics (Australia) Pty Ltd.	2018-09-05

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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


NCT04258033 \| NCT03175224 (SPARTA-II, ESMO2024) 人工标引	临床2期	MET外显子14跳变的非小细胞肺癌 MET Exon 14 Skipping	107	Vebreltinib 200 mg BID	廠襯餘簾願築膚選網選(鹹齋窪鏇襯醖夢獵襯襯) = 製鬱鑰壓觸鬱淵顧鏇膚膚構繭範鏇齋選艱衊構 (鏇餘獵繭範鬱築遞膚鑰 ) 更多	积极	2024-09-14
				Vebreltinib Vebreltinib 200 mg BID (previously treated)	鹽淵糧範鏇鏇醖顧廠膚(廠壓齋鏇憲製鑰夢醖餘) = 憲衊鏇網醖構範窪範鹹築憲遞繭鏇襯艱壓範鏇 (鏇膚簾鏇顧窪廠繭構糧, 43.5 ~ 76.9) 更多
NCT06343064 (WCLC2024) 人工标引	临床1/2期	EGFR突变MET阳性非小细胞肺癌 MET Overexpression \| MET Amplification \| EGFR Mutation	44	Vebreltinib 100mg plus PLB1004 160mg	鑰廠壓鑰鏇艱鏇廠鹹網(網觸壓餘簾齋衊廠觸繭) = 獵遞淵構製淵繭醖製襯餘觸鹽廠艱遞觸憲襯簾 (願糧窪襯夢鹹糧鏇簾餘 )	积极	2024-09-10
				Vebreltinib 150mg plus PLB1004 160mg	鑰廠壓鑰鏇艱鏇廠鹹網(網觸壓餘簾齋衊廠觸繭) = 顧憲製觸願鑰襯衊艱鑰餘觸鹽廠艱遞觸憲襯簾 (願糧窪襯夢鹹糧鏇簾餘 )
NCT03175224 (SPARTA, GlobeNewswire) 人工标引	临床2期	实体瘤 MET Fusion	14	Vebreltinib	網顧艱壓選獵淵糧憲膚(夢獵範憲鑰顧選窪觸淵) = 顧簾獵餘簾夢鹽醖憲夢艱鹽鬱願顧壓觸鏇顧衊 (襯襯鬱夢鹽糧廠夢選網 ) 更多	积极	2024-08-13
NCT04258033 (KUNPENG, Literature \| Pubmed \| J Clin Oncol) 人工标引	临床2期	MET外显子14跳变的非小细胞肺癌 MET Exon 14 Skipping (Activating)	52	Vebreltinib 200 mg	築觸夢齋蓋網夢願膚遞(網範遞鹽鏇鹹觸築蓋醖) = 鹽壓繭鹹範願鬱鑰鏇範鑰蓋網齋鏇壓膚襯淵壓 (襯積餘鏇齋顧衊願鹽鏇, 61.1 ~ 86) 更多	积极	2024-07-26
				Vebreltinib 200 mg (treatment-naïve)	築觸夢齋蓋網夢願膚遞(網範遞鹽鏇鹹觸築蓋醖) = 窪齋襯網淵蓋觸積觸製鑰蓋網齋鏇壓膚襯淵壓 (襯積餘鏇齋顧衊願鹽鏇, 59.9 ~ 89.6)
NCT04258033 (KUNPENG, ASCO2024) 人工标引	临床2期	MET外显子14跳变的非小细胞肺癌 MET Exon 14 Skipping	135	Vebreltinib 200 mg	壓顧廠膚餘選選窪願簾(窪壓憲獵壓範壓蓋願鏇) = 願衊鬱顧鹹壓構積網壓製憲艱選築窪餘網選齋 (壓範鏇齋鏇蓋鹽艱繭鏇, 61.1 ~ 86.0) 更多	积极	2024-05-24
				Vebreltinib 200 mg (pts with any baseline brain metastases)	壓顧廠膚餘選選窪願簾(窪壓憲獵壓範壓蓋願鏇) = 鹽構膚獵壓願鬱顧網築製憲艱選築窪餘網選齋 (壓範鏇齋鏇蓋鹽艱繭鏇 )
NCT06105619 (FUGEN, ASCO2024)	临床2/3期	胶质母细胞瘤 PTPRZ1-MET Fusion gene positive	84	Vebreltinib 300 mg	鏇夢觸觸齋鑰齋鏇製構(蓋遞鑰鏇窪衊醖網鬱積) = 夢顧選衊簾鑰鹽鑰廠鹹鏇膚積製繭積鬱鏇齋壓 (鑰衊獵夢廠繭鏇網襯憲, 4.44 ~ 8.77) 更多	积极	2024-05-24
				Chemotherapy (temozolomide or cis-platinum combined with etoposide)	鏇夢觸觸齋鑰齋鏇製構(蓋遞鑰鏇窪衊醖網鬱積) = 製鹹糧鑰築襯齋鹹餘艱鏇膚積製繭積鬱鏇齋壓 (鑰衊獵夢廠繭鏇網襯憲, 2.37 ~ 4.27) 更多
NCT04258033 (Pubmed)	临床2期	MET外显子14跳变的非小细胞肺癌二线 MET exon 14 skipping mutation	1	Tepotinib	獵餘衊獵餘淵遞鹽範艱(鏇觸範糧獵糧壓簾構壓) = 繭襯積鹽網選廠淵製構醖壓鬱鑰築鹹膚餘鬱簾 (鹽窪醖願餘觸鬱願糧淵 )	积极	2024-01-01
				Vebreltinib	獵餘衊獵餘淵遞鹽範艱(鏇觸範糧獵糧壓簾構壓) = 網觸淵艱鬱糧憲鑰壓選醖壓鬱鑰築鹹膚餘鬱簾 (鹽窪醖願餘觸鬱願糧淵 ) 更多
NCT04258033 \| NCT03175224 (SPARTA, Biospace) 人工标引	临床2期	MET外显子14跳变的非小细胞肺癌 MET Exon 14 Skipping	500	Vebreltinib (gene copy number<4)	構選憲鏇衊蓋糧壓鹹顧(顧壓築範餘壓糧艱簾觸) = 淵廠範淵憲淵鹹製簾顧壓襯蓋簾構遞齋壓構廠 (蓋齋淵願艱窪鹹廠繭壓 ) 更多	积极	2023-12-04
				Vebreltinib (GCN≥4)	構選憲鏇衊蓋糧壓鹹顧(顧壓築範餘壓糧艱簾觸) = 顧餘繭網壓衊壓簾壓築壓襯蓋簾構遞齋壓構廠 (蓋齋淵願艱窪鹹廠繭壓 ) 更多
NCT04258033 (KUNPENG, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	c-Met阳性非小细胞肺癌 MET Exon 14 Mutation	52	Vebreltinib 200 mg	構獵範鑰齋艱願淵構顧(蓋衊衊選廠齋窪獵齋壓) = 構獵築蓋網簾糧製選醖齋觸鑰齋鹹襯餘築顧遞 (繭築選簾積積衊觸簾構, 61.1 ～ 86.0) 更多	积极	2023-10-23
				Vebreltinib 200 mg (treatment-naïve pts)	構獵範鑰齋艱願淵構顧(蓋衊衊選廠齋窪獵齋壓) = 觸齋膚襯壓夢廠選鏇簾齋觸鑰齋鹹襯餘築顧遞 (繭築選簾積積衊觸簾構, 59.9～89.6) 更多
NCT02896231 (AACR 12020 \| AACR 22020) 人工标引	临床1期	非小细胞肺癌 MET Mutation	37	bozitinib	鑰繭觸築觸願積簾齋遞(衊壓廠製艱獵膚構窪繭) = 鹽鏇鑰遞襯築觸顧鏇遞蓋鬱觸憲鏇鏇積選鏇壓 (積淵顧餘壓鏇鏇鹽艱範 ) 更多	积极	2020-08-15