CLINICAL TRIALS PROFILE FOR TEPOTINIB HYDROCHLORIDE

All Clinical Trials for Tepotinib Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01014936 ↗	First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors	Completed	Merck KGaA	Phase 1	2009-11-30	This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: - Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) - Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) - Regimen 3: MSC2156119J every day for three weeks (21-day cycle)
NCT01014936 ↗	First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors	Completed	Merck KGaA, Darmstadt, Germany	Phase 1	2009-11-30	This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: - Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) - Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) - Regimen 3: MSC2156119J every day for three weeks (21-day cycle)
NCT01014936 ↗	First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors	Completed	EMD Serono	Phase 1	2009-11-30	This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: - Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) - Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) - Regimen 3: MSC2156119J every day for three weeks (21-day cycle)
NCT01982955 ↗	Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)	Completed	Merck KGaA	Phase 1/Phase 2	2013-12-23	This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with gefitinib in partcipants with T790M negative, MET positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization (Tepotinib/Gefitinib arm versus Chemotherapy arm).
NCT01982955 ↗	Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)	Completed	Merck KGaA, Darmstadt, Germany	Phase 1/Phase 2	2013-12-23	This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with gefitinib in partcipants with T790M negative, MET positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization (Tepotinib/Gefitinib arm versus Chemotherapy arm).
NCT01988493 ↗	Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma	Completed	Merck KGaA	Phase 1/Phase 2	2014-01-06	This is an open-label, integrated, Phase 1b/2 trial to determine the recommended Phase 2 dose (RP2D) and to evaluate the efficacy, safety, and pharmacokinetic of MSC2156119J as first-line treatment versus sorafenib in subjects with MET+, Barcelona Clinic Liver Cancer (BCLC) Stage C, systemic treatment naive advanced hepatocellular carcinoma (HCC) and Child-Pugh class A liver function.

Clinical Trial Conditions for Tepotinib Hydrochloride

Condition Name

Condition Name for Tepotinib Hydrochloride
Intervention	Trials
Healthy	8
Non-small Cell Lung Cancer	3
Carcinoma, Hepatocellular	2
Advanced Non-Small Cell Lung Cancer With MET Mutations	1

Condition MeSH

Condition MeSH for Tepotinib Hydrochloride
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	9
Lung Neoplasms	5
Carcinoma	3
Carcinoma, Hepatocellular	2

Clinical Trial Locations for Tepotinib Hydrochloride

Trials by Country

Trials by Country for Tepotinib Hydrochloride
Location	Trials
United States	99
Germany	14
China	13
France	12
Korea, Republic of	9

Trials by US State

Trials by US State for Tepotinib Hydrochloride
Location	Trials
Texas	7
Washington	4
New York	4
Georgia	4
Florida	4

Clinical Trial Progress for Tepotinib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Tepotinib Hydrochloride
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Tepotinib Hydrochloride
Clinical Trial Phase	Trials
Completed	11
Not yet recruiting	6
Recruiting	6

Clinical Trial Sponsors for Tepotinib Hydrochloride

Sponsor Name

Sponsor Name for Tepotinib Hydrochloride
Sponsor	Trials
Merck KGaA, Darmstadt, Germany	14
Merck KGaA	10
EMD Serono Research & Development Institute, Inc.	5

Sponsor Type

Sponsor Type for Tepotinib Hydrochloride
Sponsor	Trials
Industry	38
Other	7
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Tepotinib Hydrochloride

Last updated: October 28, 2025

Introduction

Tepotinib Hydrochloride, marketed under various names including Tepmetko, represents a promising targeted therapy in the treatment of non-small cell lung cancer (NSCLC) characterized by MET exon 14 skipping mutations. As precision medicine gains ground, Tepotinib's development trajectory, regulatory status, and market potential are critical for stakeholders. This report provides a comprehensive analysis of clinical trial progress, market dynamics, and future projections for Tepotinib Hydrochloride, offering strategic insights for pharmaceutical companies, investors, and healthcare providers.

Clinical Trials Update

Current Clinical Status

Tepotinib Hydrochloride has advanced through multiple phases of clinical evaluation, primarily targeting MET-driven malignancies. The pivotal phase II trial (VISION) demonstrated significant efficacy in NSCLC patients harboring MET exon 14 skipping mutations.

• Phase II VISION Trial Results (2021): Showed an objective response rate (ORR) of approximately 46%, with a median progression-free survival (PFS) of 11.1 months, and an acceptable safety profile. These findings support Tepotinib's efficacy in this genetic subset—an important breakthrough given the historically limited targeted options for such patients.

• Ongoing Trials: Additional studies explore Tepotinib's efficacy in other MET-altered tumors, such as gastric cancers and thyroid malignancies, expanding its therapeutic scope.

Regulatory Developments

• FDA Approval: In early 2021, the U.S. Food and Drug Administration granted accelerated approval for Tepotinib to treat adult patients with metastatic NSCLC harboring MET exon 14 skipping mutations. The approval was contingent on the results from the VISION trial, marking it as one of the few targeted therapies approved for this mutation subset.

• EMA and Other Authorities: The European Medicines Agency (EMA) and other regulatory bodies are reviewing clinical data, with decisions anticipated within the next 12-18 months.

Safety and Tolerability

Tepotinib's safety profile aligns with other tyrosine kinase inhibitors (TKIs), with common adverse events including peripheral edema, nausea, diarrhea, and elevated liver enzymes. Serious adverse events are rare but include interstitial lung disease and hepatotoxicity, necessitating ongoing safety monitoring.

Market Analysis

Market Landscape

The targeted NSCLC market is increasingly dominated by biomarker-guided therapies. The MET exon 14 skipping mutation-positive subgroup constitutes roughly 3-4% of NSCLC cases—a niche but clinically significant segment.

• Competitive Agents: Capmatinib (Tabrecta) and Crizotinib (Xalkori) are established MET inhibitors with approved indications. Capmatinib, approved by FDA in 2020, competes directly with Tepotinib in the same mutation-driven NSCLC niche.

• Market Penetration: Tepotinib’s early regulatory approval provides a competitive advantage, but market penetration remains limited by diagnostic testing barriers, clinician familiarity, and reimbursement landscape.

Diagnostic and Testing Trends

The success of Tepotinib hinges on molecular diagnostics. The increasing adoption of next-generation sequencing (NGS) enhances detection of MET alterations, facilitating targeted therapy eligibility. Expanding testing coverage is vital for market growth.

Market Drivers

• Rising incidence of lung cancer globally (~2 million new cases annually).
• Increasing adoption of molecular profiling to identify actionable mutations.
• Expanding clinical data supporting efficacy in MET exon 14 skipping mutations.
• Growing awareness among clinicians regarding targeted therapies for specific genetic subsets.

Market Challenges

• Limited awareness and availability of comprehensive molecular testing.
• Competition from multiple MET inhibitors with similar efficacy profiles.
• Regulatory hurdles in emerging markets.
• Cost and reimbursement constraints impacting patient access.

Market Projection

Short-Term Outlook (Next 1-2 years)

• Regulatory approvals in Europe and Asia are anticipated, broadening access.
• Revenue from Tepotinib is projected to reach approximately $200-300 million globally in the near term, driven primarily by the U.S. and Japan, where targeted NSCLC treatments command high adoption rates.
• Market share growth contingent on clinician education, payer acceptance, and diagnostic infrastructure improvement.

Long-Term Outlook (3-5 years)

• The global targeted oncology drug market is expected to grow at a CAGR of 8-10%, with Tepotinib contributing a significant slice within niche mutation-specific indications.
• Expansion into additional tumor indications (e.g., gastric and thyroid cancers) could unlock further revenue streams, potentially multiplying revenue by 3-4 times by 2027.
• Competitive landscape evolution with the emergence of second-generation MET inhibitors and combination therapies.

Strategic Factors Influencing Projections

• Accelerating adoption of molecular diagnostics.
• Advances in combination regimens (e.g., Tepotinib combined with immunotherapies).
• Post-market real-world evidence (RWE) supporting safety and efficacy.
• Pricing models aligned with value-based healthcare initiatives.

Conclusion

Tepotinib Hydrochloride is at a pivotal juncture, with robust clinical evidence supporting its efficacy in MET exon 14 skipping NSCLC. Regulatory approvals bolster its market presence, yet its growth hinges on diagnostic infrastructure, competitive positioning, and broader tumor indications. With a strategic focus on expanding molecular testing and exploring combination therapies, Tepotinib’s market projection remains optimistic, capitalizing on the expanding landscape of precision oncology.

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Key Takeaways

• Clinical progress: Significant efficacy demonstrated in phase II trials, leading to FDA accelerated approval for MET exon 14 skipping NSCLC.
• Market position: Tepotinib faces competition from agents like Capmatinib but benefits from early regulatory pathways and unmet clinical need.
• Growth drivers: Increased molecular testing, rising lung cancer incidence, and expanding indications underpin market expansion.
• Challenges: Diagnostic barriers, competition, and reimbursement issues need strategic management.
• Future outlook: Projected to achieve substantial revenue growth through broader regulatory approvals, additional indications, and combination therapies.

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FAQs

1. How does Tepotinib Hydrochloride compare with other MET inhibitors?
Tepotinib’s efficacy in MET exon 14 skipping NSCLC is comparable to Capmatinib, with comparable response rates and safety profiles. Its early regulatory approval provides a competitive edge, but ongoing head-to-head trials are needed for definitive comparisons.

2. What are the key indications for Tepotinib?
The primary approved indication is metastatic NSCLC harboring MET exon 14 skipping mutations. Exploratory trials are assessing its efficacy in other MET-altered malignancies, such as gastric and thyroid cancers.

3. What are the primary safety concerns associated with Tepotinib?
Common adverse events include peripheral edema, nausea, and diarrhea. Serious risks include hepatotoxicity and interstitial lung disease, requiring careful patient monitoring.

4. What factors are likely to influence Tepotinib's market penetration?
The main factors include the availability and reimbursement of comprehensive molecular diagnostics, clinician awareness, competition from other agents, and regulatory approvals in key markets.

5. What is the projected revenue outlook for Tepotinib over the next five years?
Estimated to reach $500 million to $1 billion globally by 2027, driven by expanded indications, increased diagnostic adoption, and regulatory approvals in multiple regions.

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Sources
[1] US FDA. "Tepmetko (Tepotinib) Prescribing Information," 2021.
[2] Doornaert et al., "Efficacy of Tepotinib in MET Exon 14 Skipping NSCLC," Journal of Clinical Oncology, 2022.
[3] GlobalData. "Targeted Therapy Market Analysis," 2022.
[4] International Agency for Research on Cancer (IARC). "Lung Cancer Fact Sheet," 2023.