RegulationOrphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC20H15F3N8

InChIKeyQHXLXUIZUCJRKV-UHFFFAOYSA-N

CAS Registry1440964-89-5

Clinical Trials associated with Vebreltinib

NCT06930794

/ RecruitingPhase 3

An Open-label, Randomized, Controlled, Multicenter Phase IIIb Clinical Study to Evaluate the Efficacy and Safety of Vebreltinib Enteric Capsule Combined With Platinum-based Doublet Chemotherapy Compared With Platinum-based Doublet Chemotherapy in Subjects With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Not Received Previous Systemic Treatment and Carry MET Amplification.

This study is an open-label, randomized, controlled, multicenter Phase IIIb clinical study, aiming to evaluate the efficacy, safety, and tolerability of Vebreltinib Enteric Capsule combined with platinum-based doublet chemotherapy compared with platinum-based doublet chemotherapy in treating subjects with locally advanced or metastatic non-squamous NSCLC who have not received previous systemic treatment and carry MET amplification.
The target population of this study is subjects with histologically confirmed locally advanced or metastatic non-squamous NSCLC who have not received previous systemic anti-tumor treatment and carry MET amplification.
This study adopts an enrichment design. The enriched population is those with MET GCN ≥ 6, and the overall population is those with MET GCN ≥ 4.
This study consists of two parts: the lead-in period (Part 1) and the randomized controlled period (Part 2). Both the lead-in period (Part 1) and the randomized controlled period (Part 2) will include a screening period (from Day -28 to Day -1), a treatment period (until the termination of treatment), and a follow-up period (including safety follow-up and survival follow-up).

Start Date30 Jun 2025

Sponsor / Collaborator

Beijing Purunao Biotechnology Co Ltd

NCT06970782

/ Not yet recruitingPhase 3

A Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure

Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure

Start Date15 May 2025

Sponsor / Collaborator

Avistone Biotechnology Co., Ltd.

NCT06780592

/ Not yet recruitingPhase 2IIT

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.

Start Date13 Jan 2025

Sponsor / Collaborator

Shanghai Huashan Hospital

[+2]

100 Clinical Results associated with Vebreltinib

100 Translational Medicine associated with Vebreltinib

100 Patents (Medical) associated with Vebreltinib

Literatures (Medical) associated with Vebreltinib

01 Jun 2025·Thoracic Cancer

Enhancing the Precision and Efficiency of Pulmonary Tumor Detection With Robotic‐Assisted ¹⁸F‐FDG PET/CT‐Guided Lung Biopsy: A Case Report

Article

Author: Liu, Jian ; Xu, Chuan ; Lu, Xia ; Li, Haiyan ; Niu, Bing ; Xu, Kai

ABSTRACT:

Sarcomatoid carcinoma, a rare and aggressive form of non‐small cell lung cancer, presents diagnostic challenges due to its heterogeneity and atypical features. This case report evaluates robotic‐assisted 18F‐FDG PET/CT‐guided percutaneous lung biopsy for improving diagnostic accuracy and efficiency in such complex lung lesions. We present the case of an 86‐year‐old male with a right upper lung lesion, chronic cough, intermittent hemoptysis, chills, and fever. Initial fiberoptic bronchoscopy and CT‐guided lung biopsy (16 min, three needle adjustments) were inconclusive. Subsequently, a robotic‐assisted PET/CT‐guided percutaneous lung biopsy was performed, targeting metabolically active regions. This procedure was completed in 6 min without any needle adjustments. This efficiency stemmed from the system's clear, precise navigation, eliminating extensive manual lesion localization and collision risk with critical structures. Unlike some navigated procedures, it avoids time‐consuming marker placement and registration. Its high accuracy guidance facilitated single needle insertion, preventing repeated adjustments, confirmatory CTs, and step‐by‐step needle advancement. Imaging confirmed a hypermetabolic lesion and mediastinal lymphadenopathy suggestive of malignancy, and histopathology revealed sarcomatoid carcinoma with pleomorphic atypical cell infiltration, high mitotic activity, and necrosis. Genetic testing identified a MET mutation, leading to targeted therapy with Bozitinib. Follow‐up imaging at 1 month showed a significant reduction in the lesion size, indicating a positive treatment response. This case underscores the potential advantages of robotic‐assisted 18F‐FDG PET/CT‐guided lung biopsy in enhancing diagnostic sensitivity and procedural efficiency by precisely targeting metabolically active areas, minimizing needle adjustments, and potentially reducing false‐negative results. Broader application in interventional radiology and oncology warrants further investigation.

03 Mar 2025·CLINICAL CANCER RESEARCH

Mucin 5AC Promotes Breast Cancer Brain Metastasis through cMET/CD44v6

Article

Author: Pothuraju, Ramesh ; Lakshmanan, Imayavaramban ; Fatima, Mahek ; Mohiuddin, Sameer ; Santamaria-Barria, Juan A. ; Ganti, Apar Kishor ; Chirravuri Venkata, Ramakanth ; Jaramillo-Gómez, Jenny A. ; Perumal, NaveenKumar ; Siddiqui, Jawed Akhtar ; Batra, Surinder Kumar ; Kanchan, Ranjana K. ; Bhatia, Rakesh ; Vengoji, Raghupathy ; Maurya, Shailendra Kumar ; Gautam, Shailendra Kumar ; Smith, Lynette M. ; Talmon, Geoffrey A. ; Zaidi, Mohd Ali Abbas ; Mahapatra, Sidharth ; Natarajan, Gopalakrishnan ; Cittelly, Diana M. ; Nasser, Mohd Wasim ; Atri, Pranita ; Khan, Md Arafat ; Chaudhary, Sanjib ; Khan, Parvez ; Cox, Jesse L. ; Rehman, Asad Ur ; Anwar, Laiba ; Alsafwani, Zahraa Wajih

Abstract:

Purpose::

Breast cancer brain metastasis remains a significant clinical problem. Mucins have been implicated in metastasis; however, whether they are also involved in breast cancer brain metastasis remains unknown. We queried databases of patients with brain metastasis and found mucin 5AC (MUC5AC) to be upregulated and therefore sought to define the role of MUC5AC in breast cancer brain metastasis.

Experimental Design::

In silico dataset analysis, RNA-sequence profiling of patient samples and cell lines, analysis of patient serum samples, and in vitro/in vivo knockdown experiments were performed to determine the function of MUC5AC in breast cancer brain metastasis. Coimmunoprecipitation was used to unravel the interactions that can be therapeutically targeted.

Results::

Global in silico transcriptomic analysis showed that MUC5AC is significantly higher in patients with breast cancer brain metastasis. Analysis of archived breast cancer brain metastasis tissue further revealed significantly higher expression of MUC5AC in all breast cancer subtypes, and high MUC5AC expression predicted poor survival in HER2+ breast cancer brain metastasis. We validated these observations in breast cancer brain metastatic cell lines and tissue samples. Interestingly, elevated levels of MUC5AC were detected in the sera of patients with breast cancer brain metastasis. MUC5AC silencing in breast cancer brain metastatic cells reduced their migration and adhesion in vitro and in brain metastasis in the intracardiac injection mouse model. We found high expression of cMET and CD44v6 in breast cancer brain metastasis, which increased MUC5AC expression via hepatocyte growth factor signaling. In addition, MUC5AC interacts with cMET and CD44v6, suggesting that MUC5AC promotes breast cancer brain metastasis via the cMET/CD44v6 axis. Inhibition of the MUC5AC/cMET/CD44v6 axis with the blood–brain barrier–permeable cMET inhibitor bozitinib (PLB1001) effectively inhibits breast cancer brain metastasis.

Conclusions::

Our study establishes that the MUC5AC/cMET/CD44v6 axis is critical for breast cancer brain metastasis, and blocking this axis will be a novel therapeutic approach for breast cancer brain metastasis.

01 Nov 2024·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

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

News (Medical) associated with Vebreltinib

01 Jun 2025

·pipelinereview.com

Avistone Announces Encouraging Results for Vebreltinib plus Andamertinib (PLB1004) in EGFR-mutated NSCLC with MET Amplification or Overexpression at ASCO Annual Meeting 2025

BEIJING, China I May 31, 2025 I Beijing Avistone Biotechnology Co., Ltd (“Avistone”), an innovative biotechnology company focused on precision oncology therapeutics, today announced that the clinical data for Vebreltinib plus Andamertinib (PLB1004), its innovative combination of potent mesenchymal-epithelial transition factor (MET) inhibitor and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), has been presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. The details of the poster presentation are provided below: Poster title: Vebreltinib plus Andamertinib (PLB1004) in EGFR-mutated NSCLC with MET Amplification or Overexpression after failure on EGFR-TKIs treatment: phase Ib/II KYLIN-1 study Abstract Number For Publication: 8632 Session: Poster Session-Lung Cancer- Non-Small Cell Metastatic Location: Poster Board, 112 Session Date/Time: 5/31/2025 1:30pm-4:30pm CDT MET amplification or overexpression is the most common “off-target” mechanism that drives resistance to EGFR-TKIs in NSCLC patients. The results from Phase Ib/II KYLIN-1 study (NCT06343064) showed that Vebreltinib plus Andamertinib demonstrated notable efficacy and manageable safety in EGFR-mutated NSCLC patients with MET amplification or overexpression after EGFR-TKIs failure. Among the 56 patients enrolled at a dose of Vebreltinib 150mg BID plus Andamertinib 80mg QD (RP2D), the confirmed overall response rate (ORR) was 50.0%, and the median progression-free survival (mPFS) was 9.9 months. In 19 patients with brain metastases, ORR was 42.1% and mPFS was 9.5 months. Grade 3 or higher treatment related adverse events (TRAEs) occurred in 19.6% of the patients. None discontinued treatment or died due to TRAEs. No new safety signal was observed. A multicenter Phase III study, KYLIN-3 study (NCT06970782), is currently ongoing to further evaluate Vebreltinib plus Andamertinib versus platinum-based doublet chemotherapy in patients with EGFR mutations, MET amplification and/or overexpression, locally advanced or metastatic NSCLC following EGFR-TKI failure. To obtain a copy of the poster, please email Avistone. About Vebreltinib Vebreltinib is an orally, potent and selective c-Met inhibitor. Chinese National Medical Products Administration (NMPA) has formally approved the use of Vebreltinib in locally advanced or metastatic NSCLC patients with MET exon 14 skipping mutations, as well as adult patients with isocitrate dehydrogenase mutant astrocytoma with the PTPRZ1-MET fusion gene or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion gene and have failed previous treatments. Currently, Chinese Center for Drug Evaluation (CDE) has formally accepted its New Drug Application (NDA) and granted it priority review, intended for patients with locally advanced or metastatic NSCLC with MET amplification. About Andamertinib (PLB1004) Andamertinib (PLB1004) is an oral, potent, irreversible, and selective EGFR-TKI with potent blood-brain barrier penetration and broad tyrosine kinase activity. Preclinical studies have shown that it can effectively and irreversibly target exon 20 insertion. Additionally, it can also potently target classical EGFR mutations, such as Del19, L858R and T790M with a high degree of selectivity. About Avistone Biotechnology Beijing Avistone Biotechnology Co., Ltd. (“Avistone”) is an innovative biotechnology company dedicated to precision therapies with significant unmet medical needs for patients worldwide. Avistone maintains an extensive pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and other solid tumors. SOURCE: Avistone Biotechnology

Phase 3Clinical ResultPriority ReviewASCOPhase 1

01 Apr 2025

·www.pharmaceutical-technology.com

Apollomics and LaunXP agree on NSCLC treatment in Asia

The therapy will be used for non-small cell lung cancer. Credit: mi_viri/Shutterstock. Apollomics and LaunXP have signed an agreement to develop and commercialise the former’s c-Met inhibitor vebreltinib combined with an epidermal growth factor receptor inhibitor (EGFRi) for treating non-small cell lung cancer (NSCLC) in Asian territories excluding Macau, mainland China and Hong Kong. LaunXP will pay Apollomics $10m upfront within 60 days of the agreement date. Apollomics is also qualified for potential regulatory and pre-commercial milestones that could total $50m, and royalties on net product sales. LaunXP will take the lead on developing the therapy and EGFRi combo for NSCLC treatment within its designated territories. Apollomics CEO Dr Guo-Liang Yu stated: “We are delighted to partner with LaunXP, who share our vision for the commercial opportunity for vebreltinib. EGFRi is currently the frontline treatment for many patients with NSCLC, and combining it with our c-Met inhibitor vebreltinib is expected to transform the standard of care. “We believe that LaunXP can advance this development programme rapidly in this patient population, bringing us closer to potentially improving outcomes for many patients with NSCLC.” The orally bioavailable selective inhibitor targets the hepatocyte growth factor/c-mesenchymal epithelial transition factor (MET) axis’ aberrant activation, which is involved in the tumour’s growth and resistance to specific therapies. It has shown promising tumour inhibitory effects in preclinical models. LaunXP president and chairman Dr Chiu-Heng Chen stated: “We are thrilled to announce this collaboration with Apollomics. We believe the preclinical and clinical data supporting the combination of a c-MET inhibitor with an EGFRi is compelling. “By delaying the emergence of mutations which cause EGFRi resistance, we hope to demonstrate clinically that better patient outcomes can be achieved.” Apollomics is exploring its use as a monotherapy across several types of tumours and evaluating the therapy in conjunction with other new treatments. In November 2023, Apollomics’ partner in China, Avistone Biotechnology, gained conditional approval from China’s National Medical Products Administration (NMPA) for the therapy to treat individuals with MET exon 14-skipping NSCLC. This therapy has not gained approval for use in any other global regions.

License out/inDrug ApprovalClinical Study

06 Mar 2025

·www.prnewswire.com

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

Drug ApprovalImmunotherapyPriority Review

100 Deals associated with Vebreltinib

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
MET gene amplification Non-small Cell Lung Cancer	China	Beijing Purunao Biotechnology Co Ltd	24 Jun 2025
Astrocytoma, IDH-Mutant	China	Beijing Purunao Biotechnology Co Ltd	17 Apr 2024
Glioblastoma	China	Beijing Purunao Biotechnology Co Ltd	17 Apr 2024
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer	China	Beijing Purunao Biotechnology Co Ltd	14 Nov 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	China	Beijing Purunao Biotechnology Co Ltd	30 Jun 2025
Non-Small Cell Lung Cancer	Phase 3	-	Avistone Biotechnology Co., Ltd.	15 May 2025
Prostatic Cancer	Phase 3	-	Avistone Biotechnology Co., Ltd.	15 May 2025
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 2	China	Avistone Biotechnology Co., Ltd.	07 Aug 2024
EGFR-mutated non-small Cell Lung Cancer	Phase 2	United States	Apollomics, Inc. (United States)	18 Jan 2022
metastatic non-small cell lung cancer	Phase 2	United States	Apollomics, Inc. (United States)	18 Jan 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 2	China	Beijing Purunao Biotechnology Co Ltd	17 Jan 2020
c-Met positive non-small cell lung cancer	Phase 2	China	Beijing Purunao Biotechnology Co Ltd	06 Jan 2020
Metastatic Clear Cell Renal Cell Carcinoma	Phase 2	Australia	Apollomics (Australia) Pty Ltd.	05 Sep 2018
Metastatic Clear Cell Renal Cell Carcinoma	Phase 2	New Zealand	Apollomics (Australia) Pty Ltd.	05 Sep 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06343064 (phase Ib/II study, ASCO2025)	Phase 1/2	METamp positive \| METov	56	Vebreltinib 150 mg BID + PLB1004 80 mg QD	mvfndvmpny(zzxvabuvlx) = 60.7% liifywtbrj (ecwysagjfh ) View more	Positive	30 May 2025
NCT04258033 \| NCT03175224 (SPARTA-II, ESMO2024) Manual	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET Exon 14 Skipping	107	Vebreltinib 200 mg BID	prbxtbtlox(daclnbmzlv) = ckgrmxtdya dtknlbfajh (lhwwaymrbe ) View more	Positive	14 Sep 2024
				Vebreltinib Vebreltinib 200 mg BID (previously treated)	eesnlmpqbo(fynowieqwi) = fjgfpubiie uegdkxekxt (qrmmuesvtg, 43.5 - 76.9) View more
NCT06343064 (WCLC2024) Manual	Phase 1/2	EGFR mutation MET positive Non-small Cell Lung Cancer MET Overexpression \| MET Amplification \| EGFR Mutation	44	Vebreltinib 100mg plus PLB1004 160mg	xzzwlrkyss(ztdgkenzzx) = nievqpmlsr ovytasgqfm (zmirpiwain )	Positive	10 Sep 2024
				Vebreltinib 150mg plus PLB1004 160mg	xzzwlrkyss(ztdgkenzzx) = mhbksxnyny ovytasgqfm (zmirpiwain )
NCT03175224 (SPARTA, GlobeNewswire) Manual	Phase 2	Solid tumor MET Fusion	14	Vebreltinib	rvemeudfdv(lhcfnjdhhm) = ngpczlpkwh qhhmotyuhm (ehyxlpcsbi ) View more	Positive	13 Aug 2024
NCT04258033 (KUNPENG, Literature \| Pubmed \| J Clin Oncol) Manual	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET Exon 14 Skipping (Activating)	52	Vebreltinib 200 mg	xjkjcrtwcx(qshkqsdqas) = lxbqcbyako atvymtgdsc (rxcpmlytdr, 61.1 - 86) View more	Positive	26 Jul 2024
				Vebreltinib 200 mg (treatment-naïve)	xjkjcrtwcx(qshkqsdqas) = thlkeqqpvo atvymtgdsc (rxcpmlytdr, 59.9 - 89.6)
NCT04258033 (KUNPENG, ASCO2024) Manual	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET Exon 14 Skipping	135	Vebreltinib 200 mg	hklupxefqa(dnzrgmtqmr) = zjevfopuhp qwjitmpyzd (vmlifgfctk, 61.1 - 86.0) View more	Positive	24 May 2024
				Vebreltinib 200 mg (pts with any baseline brain metastases)	hklupxefqa(dnzrgmtqmr) = qbbhyzkfry qwjitmpyzd (vmlifgfctk )
NCT06105619 (FUGEN, ASCO2024)	Phase 2/3	Glioblastoma PTPRZ1-MET Fusion gene positive	84	Vebreltinib 300 mg	gajdkszcfw(dsmnivefht) = zyxsbbtlqy hiidatxral (huopubziri, 4.44 - 8.77) View more	Positive	24 May 2024
				Chemotherapy (temozolomide or cis-platinum combined with etoposide)	gajdkszcfw(dsmnivefht) = lccutcjwvi hiidatxral (huopubziri, 2.37 - 4.27) View more
NCT04258033 (Pubmed)	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer Second line MET exon 14 skipping mutation	1	Tepotinib	ygnrllgmfv(vhhbgzwkaa) = proybzdroy kjmttmwvrr (pneelxbbwt )	Positive	01 Jan 2024
				Vebreltinib	ygnrllgmfv(vhhbgzwkaa) = jzxssdugkd kjmttmwvrr (pneelxbbwt ) View more
NCT04258033 \| NCT03175224 (SPARTA, Biospace) Manual	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET Exon 14 Skipping	500	Vebreltinib (gene copy number<4)	kaihlhqfir(cstidtzhmg) = npdowxwcmy wugiyfgows (rbvykqrkdc ) View more	Positive	04 Dec 2023
				Vebreltinib (GCN≥4)	kaihlhqfir(cstidtzhmg) = twpqvgpqua wugiyfgows (rbvykqrkdc ) View more
NCT04258033 (KUNPENG, ESMO 12023 \| ESMO 22023) Manual	Phase 2	c-Met positive non-small cell lung cancer MET Exon 14 Mutation	52	Vebreltinib 200 mg	tdfbtljndb(yfokhufiow) = bxyppekmpt gvglwtrxez (uzcbmlqhul, 61.1 ～ 86.0) View more	Positive	23 Oct 2023
				Vebreltinib 200 mg (treatment-naïve pts)	tdfbtljndb(yfokhufiow) = wwkwgxxaxz gvglwtrxez (uzcbmlqhul, 59.9～89.6) View more

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