RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Fast Track (Japan), Special Review Project (China)

Structure/Sequence

Molecular FormulaC29H31ClN6O3

InChIKeyKZVOMLRKFJUTLK-UHFFFAOYSA-N

CAS Registry1946826-82-9

Clinical Trials associated with Tepotinib Hydrochloride Hydrate

JPRN-jRCT1031260225

/ RecruitingPhase 3IIT

JCOG2506: A randomized phase III trial comparing MET inhibitors versus immune checkpoint inhibitor with or without chemotherapy as first-line treatment for patients with advanced non-small cell lung cancer harboring MET exon.14 skipping mutation. (DECIDE-MET)

Start Date15 Jun 2026

Sponsor / Collaborator-

NCT07619339

/ RecruitingPhase 1IIT

A Pilot Study of Tepotinib + Ivonescimab in Patients With Advanced METex14 Skipping Positive NSCLC

The researchers are doing this study to find out whether the combination of tepotinib and ivonescimab is a safe and effective treatment for people with non-small cell lung cancer (NSCLC) that is positive for METex14 skipping. The researchers will test up to two different doses of tepotinib in combination with ivonescimab to find the best dose of tepotinib that causes few or mild side effects in participants.

Start Date27 May 2026

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

CTR20255027

/ CompletedNot Applicable

评估受试制剂盐酸特泊替尼片与参比制剂盐酸特泊替尼片（拓得康®）在餐后状态下作用于健康成年受试者的单中心、开放、随机、单剂量、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, crossover bioequivalence study evaluating the effects of the investigational formulation terpoltinib hydrochloride tablets and the reference formulation terpoltinib hydrochloride tablets (Tordecan®) on healthy adult subjects in a postprandial state.

主要研究目的研究餐后状态下单次口服受试制剂盐酸特泊替尼片与参比制剂盐酸特泊替尼片（拓得康®）在健康成年受试者体内的药代动力学，评价餐后状态下口服两种制剂的生物等效性。次要研究目的研究受试制剂盐酸特泊替尼片和参比制剂“拓得康®”在健康受试者中的安全性。

[Translation]

Primary Study Objective: To investigate the pharmacokinetics of a single oral dose of the test formulation terpoxtinib hydrochloride tablets and the reference formulation terpoxtinib hydrochloride tablets (Tordecan®) in healthy adult subjects after a meal, and to evaluate the bioequivalence of the two formulations after an oral dose. Secondary Study Objective: To investigate the safety of the test formulation terpoxtinib hydrochloride tablets and the reference formulation "Tordecan®" in healthy subjects.

Start Date15 Jan 2026

Sponsor / Collaborator

Qilu Pharmaceutica Hainanco Ltd.

100 Clinical Results associated with Tepotinib Hydrochloride Hydrate

100 Translational Medicine associated with Tepotinib Hydrochloride Hydrate

100 Patents (Medical) associated with Tepotinib Hydrochloride Hydrate

286

Literatures (Medical) associated with Tepotinib Hydrochloride Hydrate

31 Dec 2026·Lung Cancer Management

Cost-effectiveness analysis of tepotinib vs capmatinib as subsequent therapy in MET exon 14-mutated non-small-cell lung cancer

Review

Author: Zhong, Lu ; Liu, Tong ; Liu, Mengmeng

BACKGROUND:

This study evaluated the cost-effectiveness of Tepotinib versus Capmatinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with MET Exon 14 Skipping Mutations in China.

METHODS:

An economic evaluation using a 3-state partitioned survival model assessed the cost-effectiveness of Tepotinib versus Capmatinib. The Kaplan-Meier (KM) curves for overall survival (OS) and progression-free survival (PFS) from two clinical trials were digitally extracted. The Exponential model with matching-adjusted indirect comparison (MAIC) was employed at the end of the trials to extrapolate the long-term survivals.

RESULTS:

The estimated cost and utility of Tepotinib treatment were higher than those of Capmatinib treatment, respectively (95,392.54 USD vs. 51,003.63 USD; 2.11 QALYs vs 1.38 QALYs). The incremental cost-effectiveness ratio (ICER) of Capmatinib treatment vs. Tepotinib treatment was calculated at 60,977.28 USD/QALY.

CONCLUSIONS:

Tepotinib was not cost-effective compared to Capmatinib as the second-line treatment for advanced or metastatic NSCLC patients with MET exon 14 skipping mutations in China.

31 Dec 2026·RENAL FAILURE

A tri-scale in silico framework integrating pharmacovigilance and mechanistic modeling suggests tepotinib-associated acute kidney injury risk

Article

Author: Bai, Zhixun ; Wang, Qin ; Zheng, Rubin ; Han, Jinfen ; Lyu, Jiayi ; Lu, Jing ; Deng, Miao ; Chen, Jiaxi

Proactive safety evaluation of molecularly targeted therapies requires generalizable frameworks that integrate real-world evidence with mechanistic insights. As a case in point, tepotinib, a mesenchymal-epithelial transition (MET) inhibitor for non-small cell lung cancer, has a known pulmonary toxicity profile, but its link to acute kidney injury (AKI) and underlying mechanism remain unclear. We devised a tri-scale in silico strategy encompassing population-scale pharmacovigilance signal extraction from the FDA Adverse Event Reporting System (FAERS) (2020-2025) via disproportionality analysis (Reporting Odds Ratio, ROR, and Proportional Reporting Ratio, PRR), network toxicology-based multi-target exploration for shared target and hub gene identification, and mechanistic docking-based molecular plausibility assessment using the Cavity-detection guided Blind Docking (CB-Dock2) platform. Pharmacovigilance analysis identified a significant renal impairment signal (ROR = 20.60). Network toxicology suggested potential nephrotoxicity and revealed 173 shared targets and prioritizing six hub genes (HSP90AA1, AKT1, EGFR, CASP3, TNF, SRC). These genes were shown to be critically involved in PI3K-Akt and MAPK pathways. Molecular docking revealed high-affinity binding between tepotiniband all six hub targets (Vina scores: -8.0 to -10.6 kcal/mol), providing a structural basis for the postulated mechanistic link to AKI. These findings not only highlight the necessity for enhanced renal monitoring in tepotinib-treated patients but, more broadly, establish the FAERS-NetDock Pipeline as a reusable, generalizable and hypothesis-generating framework for evaluating tyrosine kinase inhibitors (TKIs)-induced nephrotoxicity; this framework is immediately applicable to profiling the safety of other TKIs (e.g. crizotinib, capmatinib, savolitinib, afatinib and osimertinib) and is readily adaptable for de-risking a wider spectrum of targeted therapies.

01 Oct 2026·Journal of Stomatology Oral and Maxillofacial Surgery

The HGF/c-Met signaling axis: A master regulator of invasion and metastasis in oral squamous cell carcinoma

Review

Author: Akhrorova, Malika ; Adil, Mohaned ; Sameer, Hayder Naji ; Bethanney Janney, J ; Hussein, Wael Sheet ; Al-Hussainy, Ali Fawzi ; Renuka Jyothi, S ; Sinha, Aashna ; Singh, Gurjant ; Mustafa, Wael Waleed ; Salih, Rasim M ; Nayak, Priya Priyadarshini

BACKGROUND:

Oral squamous cell carcinoma (OSCC) is a major global health concern because local invasion and regional lymph node metastasis drive poor outcomes. The hepatocyte growth factor (HGF)/c-Met signaling axis is a key regulator of this aggressive phenotype.

OBJECTIVE:

This narrative review evaluates evidence linking HGF/c-Met signaling to OSCC progression, tumor microenvironment interactions, treatment resistance, prognostic assessment, and therapeutic targeting.

FINDINGS:

HGF/c-Met activation promotes EMT, MMP expression, cell motility, CAF-mediated crosstalk, lymphangiogenesis, perineural invasion, and EGFR inhibitor resistance through PI3K/AKT, RAS/MAPK, and STAT3 signaling. Although c-Met overexpression often correlates with poor prognosis, clinical findings are not fully consistent. Small-molecule inhibitors (crizotinib, cabozantinib, and tepotinib) and monoclonal antibodies (onartuzumab and rilotumumab) may be most useful within biomarker-guided combination regimens.

CONCLUSIONS:

HGF/c-Met signaling represents a clinically relevant driver and therapeutic vulnerability in OSCC. Standardized biomarkers and rational combination strategies are required to overcome resistance and improve patient survival.

News (Medical) associated with Tepotinib Hydrochloride Hydrate

02 Jun 2026

·www.biospace.com

U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for Itovebi™ (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation

Foundation Medicine’s tissue test can now be used in addition to its blood-based test, FoundationOne ® Liquid CDx, to identify more patients for whom Itovebi™ may be appropriate With this approval, Foundation Medicine has eight companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company 1 BOSTON--(BUSINESS WIRE)-- Foundation Medicine, Inc ., a global, patient-focused precision medicine company , today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne ® CDx to be used as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib (Ibrance ® ) and fulvestrant. Itovebi is a therapy developed by Genentech, a member of the Roche group, which is approved for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. This decision from the FDA follows the approval of FoundationOne ® Liquid CDx, Foundation Medicine’s blood-based comprehensive genomic profiling (CGP) test, for the same therapy combination and indication in October 2024. Of all breast cancer cases, approximately 70% are HR-positive, HER2-negative. 2 Within this patient population, PIK3CA is mutated in approximately 40% of patients. 3 An analysis of the agreement of identified PIK3CA mutation status between the FoundationOne CDx and FoundationOne Liquid CDx tests for patients in the INAV0120 trial demonstrated high concordance between the two assays. “The prevalence of PIK3CA mutations found in HR-positive, HER2-negative breast cancer makes it extremely important to have high quality, FDA-approved tests to match patients to the most effective therapy options in a timely manner,” said Todd Druley, M.D., Ph.D., chief medical officer at Foundation Medicine. “While actionable genomic alterations like PIK3CA may be identified by blood-based biopsy, some patients’ tumors may not be shedding adequate levels of tumor DNA into the blood for these alterations to be detected. In these cases, confirmatory tissue testing may help match more breast cancer patients to this therapy.” Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. With this most recent approval, Foundation Medicine has eight FDA-approved companion diagnostic indications for breast cancer, and over 100 approved CDx indications in total, three times more than any other comprehensive genomic profiling company. 1,4 “When someone is diagnosed with metastatic breast cancer or experiences a recurrence of their disease, making decisions about treatment can feel extremely overwhelming,” said Jean A. Sachs, MSS, MLSP, chief executive officer at Living Beyond Breast Cancer. “Having two high quality FDA-approved biomarker tests to detect PIK3CA mutations using different sample types opens more doors to help match patients to this targeted treatment regimen in the first line setting.” About Foundation Medicine Foundation Medicine is a global, patient-focused precision medicine company delivering high-quality, transformative diagnostic solutions in cancer and other diseases. We provide tests and solutions to transform care throughout a patient’s experience, from defining a diagnosis to determining the appropriate treatment to ongoing monitoring. We help accelerate the development of new personalized therapies by leveraging our vast knowledge of precision medicine, real world data and AI-powered tools, expanding the information our diagnostic solutions provide to enable improved outcomes for patients. Every day, we are inspired to think differently to transform the lives of people living with cancer and other diseases. For more information, visit us at and follow us on LinkedIn , X , YouTube , Facebook and Instagram . About FoundationOne ® CDx FoundationOne ® CDx is for prescription use only and is an FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy which may pose a risk. For the complete label, including companion diagnostic indications and important risk information, please visit . About FoundationOne ® Liquid CDx FoundationOne ® Liquid CDx is for prescription use only and is an FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes, rearrangements in 8 genes and copy number alterations in 3 genes, and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. When considering eligibility for ROZLYTREK ® based on the detection of NTRK1/2/3 and ROS1 fusions, or for TEPMETKO ® based on the detection of MET SNVs and indels that lead to MET exon 14 skipping, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit . Foundation Medicine ® and FoundationOne ® are registered trademarks of Foundation Medicine, Inc. 1 Data on File, Foundation Medicine, Inc., 2025 2 Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst . 2014;106(5). 3 Bhave, M.A., Quintanilha, J.C.F., Tukachinsky, H. et al. Comprehensive genomic profiling of ESR1 , PIK3CA , AKT1 , and PTEN in HR(+)HER2(−) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice. Breast Cancer Res Treat . 2024;207:599–609. 4 Data on File, Foundation Medicine, Inc., 2026 Contacts Holly Campbell, 480-213-8368 newsroom@foundationmedicine.com

Drug ApprovalClinical Study

01 Jun 2026

·www.biospace.com

US FDA Approves FoundationOne®CDx and FoundationOne®Liquid CDx as Companion Diagnostics for TALZENNA® (talazoparib) in Combination with XTANDI® (enzalutamide) to Identify Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

With these approvals, Foundation Medicine now has nine companion diagnostic indications for prostate cancer, the most of any company 1 BOSTON--(BUSINESS WIRE)-- Foundation Medicine, Inc. , a global, patient-focused precision medicine company, today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx and FoundationOne®Liquid CDx to be used as companion diagnostics for Pfizer’s TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide) to identify patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). TALZENNA is first and only PARP inhibitor approved for use with an existing standard of care (XTANDI) for adult patients with both BRCA mutated and non-BRCA HRR gene-mutated mCRPC. Prostate cancer is the second most common cancer in men, with approximately 1 in 8 diagnosed during their lifetime. 2 mCRPC occurs when prostate cancer grows and spreads to other parts of the body despite hormone therapy that lowers testosterone. HRR gene mutations are present in approximately 20-30% of patients with mCRPC. 3 While treatment options have expanded in recent years, patients with mCRPC often continue to face poor prognosis and limited treatment options. 4 “Every patient deserves clear, personalized answers when it comes to their treatment plan, but one-size-fits all approaches do not work for everyone. As more targeted therapies become available to treat mCRPC, it is incredibly important to have high-quality tissue- and blood-based companion diagnostics available to best inform personalized treatment plans for each unique patient,” said Todd Druley, M.D., Ph.D., Chief Medical Officer at Foundation Medicine. “These two approvals further strengthen Foundation Medicine’s leadership in companion diagnostics and underscore the critical role of comprehensive genomic profiling in connecting patients with targeted treatment options.” Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. 5 With this most recent approval, Foundation Medicine has nine FDA-approved companion diagnostic indications for prostate cancer, and over 100 approved CDx indications in total, three times more than any other comprehensive genomic profiling company. 1,6 “Too many prostate cancer patients still can’t access the biomarker tests that should guide their treatment, not because the tests don’t exist, but because access isn’t consistent or equitable,” said Courtney Bugler, President and CEO of ZERO Prostate Cancer. “Biomarker testing gives patients and their families the clarity they need to understand their diagnosis and make informed decisions about care. Every person deserves access to personalized treatment information, regardless of their doctor, their diagnosis, or their ZIP code.” About Foundation Medicine Foundation Medicine is a global, patient-focused precision medicine company delivering high-quality, transformative diagnostic solutions in cancer and other diseases. We provide tests and solutions to transform care throughout a patient’s experience, from defining a diagnosis to determining the appropriate treatment to ongoing monitoring. We help accelerate the development of new personalized therapies by leveraging our vast knowledge of precision medicine, real world data and AI-powered tools, expanding the information our diagnostic solutions provide to enable improved outcomes for patients. Every day, we are inspired to think differently to transform the lives of people living with cancer and other diseases. For more information, visit us at and follow us on LinkedIn , X , YouTube , Facebook , Instagram and BlueSky . About FoundationOne®CDx FoundationOne®CDx is for prescription use only and is an FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy which may pose a risk. For the complete label, including companion diagnostic indications and important risk information, please visit . About FoundationOne®Liquid CDx FoundationOne®Liquid CDx is for prescription use only and is an FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes, rearrangements in 8 genes and copy number alterations in 3 genes, and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. When considering eligibility for ROZLYTREK® based on the detection of NTRK1/2/3 and ROS1 fusions, or for TEPMETKO® based on the detection of MET SNVs and indels that lead to MET exon 14 skipping, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit . Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc. 1 Data on File, Foundation Medicine, Inc. 2025 2 Cancer.org. “American Cancer Society Key Statistics for Prostate Cancer.” January 2026. 3 de Bono J, et al. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 May 28;382(22):2091-2102. doi: 10.1056/NEJMoa1911440. Epub 2020 Apr 28. PMID: 32343890. 4 Freedland SJ, Davis M, Epstein AJ, Arondekar B, Ivanova JI. Real-world treatment patterns and overall survival among men with metastatic castration-resistant prostate cancer (mCRPC) in the US Medicare population. Prostate Cancer Prostatic Dis 2024;27(2):327-33. 5 Data on File, Foundation Medicine, Inc., 2025 6 Data on File, Foundation Medicine, Inc., 2026 Contacts Holly Campbell, 480-213-8368 newsroom@foundationmedicine.com

Drug Approval

31 May 2026

·www.globenewswire.com

Precede Biosciences Presents New ASCO 2026 Data Demonstrating Ability of Precede Bio Insight™ to Decode MET-Driven Biology and Resistance in Advanced NSCLC

Data include assessment of MET expression, tumor and immune pathway activity, and lineage plasticity from just 1 mL of plasma in advanced NSCLCPlasma MET test showed high concordance with tissue IHC/FISH in EGFR-mutated NSCLC following progression on first-line targeted therapy (AUC=0.97)Baseline and longitudinal profiling in METex14 skipping NSCLC identified biology associated with therapeutic sensitivity and resistance, including MET pathway activity, neuroendocrine lineage plasticity, and expression of ADC target GD2 synthase (B4GALNT1) BOSTON, May 31, 2026 (GLOBE NEWSWIRE) -- Precede Biosciences, a company powering next-generation precision medicine through its functional liquid biopsy platform, today announced two new data presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29 to June 2 in Chicago, Illinois. The data highlight how functional information beyond genomics in patients with advanced non-small cell lung cancer (NSCLC), including target expression, pathway activity, and cell-state changes associated with response and resistance to targeted therapies, can be revealed from only 1 mL of plasma using Precede Bio Insight™. “Patients with advanced NSCLC in whom MET is an important disease driver often require multiple lines of therapy, underscoring the need to better understand the biology driving response and resistance,” said J. Carl Barrett, PhD, Chief Scientific Officer of Precede Biosciences. “For drug developers working to advance MET-targeted therapies, these data demonstrate the ability of our platform to provide a broad functional view of tumor biology from plasma that can help guide patient selection and rational therapeutic development strategies.” ASCO 2026 Presentations Comprehensive Epigenomic Profiling of Plasma for Non-invasive Detection of MET Activation Uncovers MET-associated Biology in Patients with EGFR-mutated Advanced NSCLC and Progression on Osimertinib (Abstract 8642)Plasma Epigenomic Profiling Identifies Mechanisms of Sensitivity and Resistance to Tepotinib in METex14 Skipping Metastatic NSCLC (Abstract 8637) Data presentations are available in the presentations section of the company website at www.precede.bio. About Precede Biosciences Precede Biosciences is a precision diagnostics and data company redefining what can be learned from a simple blood draw. By unlocking genome-wide transcriptional biology through a novel, comprehensive epigenomics approach, the company enables researchers and clinicians to better understand disease biology in real time. By partnering with developers of new medicines and advancing its own diagnostic tests, Precede Bio is working toward a future in which drug development is more efficient and patients receive minimally invasive diagnostics and treatments aligned to the biology of their disease. To learn more, visit www.precede.bio or follow us on LinkedIn. About Precede Bio Insight™ Precede Bio Insight is a first-of-its-kind product that enables genome-wide liquid biopsy of gene expression from just 1 mL of plasma. Powered by comprehensive epigenomic profiling of cell-free DNA and advanced machine learning, Insight generates quantitative measures of tumor and immune transcriptional biology, including target expression, pathway activity, and cell states. This approach provides a unified, functional view of tumor biology to inform critical R&D decisions, including patient selection and the design of more precise treatment combinations and sequencing strategies. Precede Bio Insight is available for research and development collaborations. To learn more or to start a partnership discussion, visit insight.precede.bio. Media Contact:Donelle M. Gregorymedia@precede.bio

ASCO

100 Deals associated with Tepotinib Hydrochloride Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D11717	-	L01XE	DB15133

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer	South Korea	Merck & Co., Inc.	23 Nov 2021
Non-Small Cell Lung Cancer	United States	EMD Serono, Inc.	03 Feb 2021
c-Met positive non-small cell lung cancer	Japan	Merck KGaA	25 Mar 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	United States	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Belgium	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Czechia	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	France	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Italy	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Russia	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	Spain	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
RAS/BRAF Wild Type Colorectal Cancer	Phase 2	United Kingdom	EMD Serono Research & Development Institute, Inc.	28 Jan 2021
Advanced Malignant Solid Neoplasm	Phase 2	South Korea	Merck KGaA	16 Jan 2020
Breast Cancer	Phase 2	South Korea	Merck KGaA	16 Jan 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02864992 (VISION, ASCO2026)	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET exon 14 skipping	26	Tepotinib 500 mg (MET exon 14 skipping NSCLC + Duration of Response >36 months)	izncofqzoq(dhtjiikybq) = In 12 patients who discontinued treatment, reasons for discontinuation were: adverse events (5 patients [peripheral edema in 2 patients]), disease progression per investigator (3 patients), non-compliance (1 patient), consent withdrawal (1 patient), and other reasons (2 patients). xzknxckaah (byilvzsxqw ) View more	Positive	29 May 2026
ESMO_ASIA2025	Not Applicable	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET exon 14 skipping mutations	55	Tepotinib	fkumxcukje(dkarxjyjei) = odmpynsfpn wqxjvfphqi (ylszpgbqvw ) View more	Positive	05 Dec 2025
				Tepotinib (1L)	fkumxcukje(dkarxjyjei) = gqikxwewnn wqxjvfphqi (ylszpgbqvw ) View more
ESMO_ASIA2025	Not Applicable	MET gene amplification Non-small Cell Lung Cancer MET gene copy number	16	Tepotinib	hfqkpabaft(cgaqdpvofc) = qplovvqdel wrhrajmfsm (fzysczmmfi, 2 - 26) View more	Positive	05 Dec 2025
				Tepotinib	hfqkpabaft(cgaqdpvofc) = lrqaaywfgf wrhrajmfsm (fzysczmmfi, 3 - 24) View more
REAL-MET (ESMO2025)	Not Applicable	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET exon 14 skipping	62	Tepotinib (Brain Metastases)	jbhvnualqa(qzksfgnrbv) = wudflscsjn ipztbpqser (oeljizgebz ) View more	Positive	17 Oct 2025
				Tepotinib (No Brain Metastases)	kkimosyxax(hsniarngga) = ndbdlvdgpb gmawrqvnht (bucvqdazgr, 1.7 - 12.1) View more
VISION study (ASCO2025)	Not Applicable	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer First line PD-L1	98	Tepotinib	mxzbcipbft(yjcfrmxqct) = Grade 3 or higher edema occurring in 12.9% of the patients imdbupslws (txakulkqgl )	Positive	30 May 2025
				Immune Checkpoint Inhibitors
NCT02864992 (VISION study, ESMO_ELCC2025)	Phase 2	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer First line METex14 skipping \| METamp	313	Tepotinib 500 mg	iloczdgbii(dmlrvzgsej) = 15.7% of pts discontinued treatment due to TRAEs xvswqxkswn (hrudztdpnf ) View more	Positive	26 Mar 2025
NCT03940703 (INSIGHT 2, Pubmed \| Lancet Oncol) Manual	Phase 2	Non-Small Cell Lung Cancer Second line EGFR Mutation \| MET Amplification	128	Tepotinib plus osimertinib (progression on first-line osimertinib)	ckvijdujcy(tbxiwkvrta) = ddclmsatiq gupxlcnvei (lfdohfaazu, 39.7 - 60.3) View more	Positive	25 Aug 2024
NCT03546608 (CTgov)	Phase 1	Hepatic Insufficiency	18	Tepotinib (Healthy Participants (Control))	hedyygjdbf(fgfkhehtde) = tppgszojmz wuevdhdhfq (hhrpszjqxu, 13.4) View more	-	12 Aug 2024
				Tepotinib (Mild Hepatic Impairment (Child-Pugh Class A))	hedyygjdbf(fgfkhehtde) = zibhvfoqrk wuevdhdhfq (hhrpszjqxu, 63.9) View more
NCT03940703 (INSIGHT 2, CTgov)	Phase 2	Recurrent Non-Small Cell Lung Cancer	140	Tepotinib (Tepotinib Mono-therapy)	bopyrfecst(czytekkouy) = kzshjqddzp twpgbiqcbd (pbppijshwb, kjfgobbihy - elydpcfezr) View more	-	04 Jun 2024
				Tepotinib+Osimertinib (Tepotinib and Osimertinib)	bopyrfecst(czytekkouy) = ldijbbgltp twpgbiqcbd (pbppijshwb, wdaaaamhdq - yjmzsotajt) View more
NCT02864992 (VISION, ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer \| MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET Exon 14 Skipping	248	tepotinib (Brain metastases)	vaxucsrlxk(eyvnuimqlo) = pxaqctxhlw fbbgakinei (yuytasscdx, 2.41) View more	Positive	24 May 2024
				tepotinib (Liver metastases)	vaxucsrlxk(eyvnuimqlo) = ayextypftj fbbgakinei (yuytasscdx, 2.27) View more

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

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Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis