Tepotinib Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Tepotinib comprises 23 peer-reviewed publications across 15 journals, 0 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Carcinoma, Non-Small-Cell Lung, Neoplasms, Carcinoma, Hepatocellular, and Stomach Neoplasms. Most recent publication: Prospective evaluation of genomics-guided off-label treatment., Nature, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Tepotinib plus gefitinib in patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study): an open-label, phase 1b/2, multicentre, randomised trial.
    Wu YL, Cheng Y, Zhou J, et al. · Lancet Respir Med · 2020
    PubMed: PMID 32479794 · NCT01982955 · Carcinoma, Non-Small-Cell Lung
  2. Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression.
    Ryoo BY, Cheng AL, Ren Z, et al. · Br J Cancer · 2021
    PubMed: PMID 33972742 · NCT01988493 · Carcinoma, Hepatocellular
  3. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations.
    Paik PK, Felip E, Veillon R, et al. · N Engl J Med · 2020
    PubMed: PMID 32469185 · NCT02864992 · Carcinoma, Non-Small-Cell Lung
  4. Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial.
    Wu YL, Guarneri V, Voon PJ, et al. · Lancet Oncol · 2024
    PubMed: PMID 39089305 · NCT03940703 · Carcinoma, Non-Small-Cell Lung
  5. Prospective evaluation of genomics-guided off-label treatment.
    Verkerk K, Spiekman AC, Haj Mohammad SF, et al. · Nature · 2026
  6. Tepotinib Treatment in Patients With MET Exon 14-Skipping Non-Small Cell Lung Cancer: Long-term Follow-up of the VISION Phase 2 Nonrandomized Clinical Trial.
    Mazieres J, Paik PK, Garassino MC, et al. · JAMA Oncol · 2023
    PubMed: PMID 37270698 · NCT02864992 · Carcinoma, Non-Small-Cell Lung
  7. The role of the molecular tumor board: learnings from the ROME trial.
    Marchetti P, Curigliano G, Westphalen CB, et al. · NPJ Precis Oncol · 2026
    PubMed: PMID 41963505 · NCT04591431 (ROME) · Carcinoma, Non-Small-Cell Lung
  8. Genomically matched therapy in advanced solid tumors: the randomized phase 2 ROME trial.
    Marchetti P, Curigliano G, Biffoni M, et al. · Nat Med · 2025
    PubMed: PMID 41023484 · NCT04591431 (ROME) · Carcinoma, Non-Small-Cell Lung

Publications by year

20202026: 23 publications.

2020
2
2021
2
2022
6
2023
6
2024
3
2025
2
2026
2

Publications by indication

Carcinoma, Non-Small-Cell Lung (13)

  • The role of the molecular tumor board: learnings from the ROME trial.
    NPJ Precis Oncol · 2026 · PMID 41963505 · NCT04591431
  • Genomically matched therapy in advanced solid tumors: the randomized phase 2 ROME trial.
    Nat Med · 2025 · PMID 41023484 · NCT04591431
  • Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial.
    Lancet Oncol · 2024 · PMID 39089305 · NCT03940703
  • Efficacy and safety of tepotinib in Asian patients with advanced NSCLC with MET exon 14 skipping enrolled in VISION.
    Br J Cancer · 2024 · PMID 38575731 · NCT02864992
  • Assessment of the potential of the MET inhibitor tepotinib to affect the pharmacokinetics of CYP3A4 and P-gp substrates.
    Invest New Drugs · 2023 · PMID 37415001 · NCT03492437

Neoplasms (6)

  • Prospective evaluation of genomics-guided off-label treatment.
    Nature · 2026 · PMID 41986720 · NCT02925234
  • Efficacy of Pembrolizumab and Biomarker Analysis in Patients with WGS-Based Intermediate to High Tumor Mutational Load: Results from the Drug Rediscovery Protocol.
    Clin Cancer Res · 2024 · PMID 38630551 · NCT02925234
  • Limited clinical activity of palbociclib and ribociclib monotherapy in advanced cancers with cyclin D-CDK4/6 pathway alterations in the Dutch DRUP and Australian MoST trials.
    Int J Cancer · 2023 · PMID 37424386 · NCT02925234
  • Efficacy, safety and biomarker analysis of durvalumab in patients with mismatch-repair deficient or microsatellite instability-high solid tumours.
    BMC Cancer · 2023 · PMID 36870947 · NCT02925234
  • Efficacy and toxicity of vemurafenib and cobimetinib in relation to plasma concentrations, after administration via feeding tube in patients with BRAF-mutated thyroid cancer: a case series and review of literature.
    Cancer Chemother Pharmacol · 2022 · PMID 35598186 · NCT02925234

Carcinoma, Hepatocellular (3)

  • Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations.
    Cancer Chemother Pharmacol · 2022 · PMID 35771259 · NCT01988493
  • Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression.
    Br J Cancer · 2021 · PMID 33972742 · NCT01988493
  • Phase 1b/2 trial of tepotinib in sorafenib pretreated advanced hepatocellular carcinoma with MET overexpression.
    Br J Cancer · 2021 · PMID 33824476 · NCT02115373

Stomach Neoplasms (1)

  • Adding Docetaxel to Tepotinib to Overcome Oligoprogression in MET Exon 14 Skipping-Mutated NSCLC When Local Therapy Is Unfeasible: A Case Report.
    Case Rep Oncol Med · 2025 · PMID 40880848 · NCT05439993

Publications by journal

All Tepotinib publications (23)

2026 (2 papers)

  1. Prospective evaluation of genomics-guided off-label treatment.
    Verkerk K, Spiekman AC, Haj Mohammad SF, et al. · Nature · 2026 · Derived
  2. The role of the molecular tumor board: learnings from the ROME trial.
    Marchetti P, Curigliano G, Westphalen CB, et al. · NPJ Precis Oncol · 2026 · Derived
    PubMed: PMID 41963505 · NCT04591431 (ROME) · Carcinoma, Non-Small-Cell Lung

2025 (2 papers)

  1. Adding Docetaxel to Tepotinib to Overcome Oligoprogression in MET Exon 14 Skipping-Mutated NSCLC When Local Therapy Is Unfeasible: A Case Report.
    Sánchez García D, Grau Mirete B, Rodríguez Payá P, et al. · Case Rep Oncol Med · 2025 · Derived
    PubMed: PMID 40880848 · NCT05439993 · Stomach Neoplasms
  2. Genomically matched therapy in advanced solid tumors: the randomized phase 2 ROME trial.
    Marchetti P, Curigliano G, Biffoni M, et al. · Nat Med · 2025 · Derived
    PubMed: PMID 41023484 · NCT04591431 (ROME) · Carcinoma, Non-Small-Cell Lung

2024 (3 papers)

  1. Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial.
    Wu YL, Guarneri V, Voon PJ, et al. · Lancet Oncol · 2024 · Derived
    PubMed: PMID 39089305 · NCT03940703 · Carcinoma, Non-Small-Cell Lung
  2. Efficacy and safety of tepotinib in Asian patients with advanced NSCLC with MET exon 14 skipping enrolled in VISION.
    Kato T, Yang JC, Ahn MJ, et al. · Br J Cancer · 2024 · Derived
    PubMed: PMID 38575731 · NCT02864992 · Carcinoma, Non-Small-Cell Lung
  3. Efficacy of Pembrolizumab and Biomarker Analysis in Patients with WGS-Based Intermediate to High Tumor Mutational Load: Results from the Drug Rediscovery Protocol.
    Geurts BS, Zeverijn LJ, Leek LVM, et al. · Clin Cancer Res · 2024 · Derived

2023 (6 papers)

  1. Limited clinical activity of palbociclib and ribociclib monotherapy in advanced cancers with cyclin D-CDK4/6 pathway alterations in the Dutch DRUP and Australian MoST trials.
    Zeverijn LJ, Looze EJ, Thavaneswaran S, et al. · Int J Cancer · 2023 · Derived
  2. Assessment of the potential of the MET inhibitor tepotinib to affect the pharmacokinetics of CYP3A4 and P-gp substrates.
    Yalkinoglu Ö, Becker A, Krebs-Brown A, et al. · Invest New Drugs · 2023 · Derived
    PubMed: PMID 37415001 · NCT03492437 · Carcinoma, Non-Small-Cell Lung
  3. Tepotinib Treatment in Patients With MET Exon 14-Skipping Non-Small Cell Lung Cancer: Long-term Follow-up of the VISION Phase 2 Nonrandomized Clinical Trial.
    Mazieres J, Paik PK, Garassino MC, et al. · JAMA Oncol · 2023 · Derived
    PubMed: PMID 37270698 · NCT02864992 · Carcinoma, Non-Small-Cell Lung
  4. Tepotinib in patients with non-small cell lung cancer with high-level MET amplification detected by liquid biopsy: VISION Cohort B.
    Le X, Paz-Ares LG, Van Meerbeeck J, et al. · Cell Rep Med · 2023 · Derived
    PubMed: PMID 37944528 · NCT02864992 · Carcinoma, Non-Small-Cell Lung
  5. Plain language summary of the development of tepotinib: a treatment for a subtype of non-small cell lung cancer called MET exon 14 skipping.
    Hallick J, Baird AM, Falchook G, et al. · Future Oncol · 2023 · Derived
    PubMed: PMID 36999526 · NCT02864992 · Carcinoma, Non-Small-Cell Lung
  6. Efficacy, safety and biomarker analysis of durvalumab in patients with mismatch-repair deficient or microsatellite instability-high solid tumours.
    Geurts BS, Battaglia TW, van Berge Henegouwen JM, et al. · BMC Cancer · 2023 · Derived

2022 (6 papers)

  1. Population pharmacokinetic analysis of tepotinib, an oral MET kinase inhibitor, including data from the VISION study.
    Xiong W, Papasouliotis O, Jonsson EN, et al. · Cancer Chemother Pharmacol · 2022 · Derived
    PubMed: PMID 35385993 · NCT02864992 · Carcinoma, Non-Small-Cell Lung
  2. Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations.
    Xiong W, Hietala SF, Nyberg J, et al. · Cancer Chemother Pharmacol · 2022 · Derived
    PubMed: PMID 35771259 · NCT01988493 · Carcinoma, Hepatocellular
  3. Efficacy and toxicity of vemurafenib and cobimetinib in relation to plasma concentrations, after administration via feeding tube in patients with BRAF-mutated thyroid cancer: a case series and review of literature.
    van Berge Henegouwen JM, van der Wijngaart H, Zeverijn LJ, et al. · Cancer Chemother Pharmacol · 2022 · Derived
  4. MET gene amplification is a mechanism of resistance to entrectinib in ROS1+ NSCLC.
    Tyler LC, Le AT, Chen N, et al. · Thorac Cancer · 2022 · Derived
    PubMed: PMID 36101520 · NCT04739358 · Carcinoma, Non-Small-Cell Lung
  5. Comprehensive Molecular Characterization Reveals Genomic and Transcriptomic Subtypes of Metastatic Urothelial Carcinoma.
    Nakauma-González JA, Rijnders M, van Riet J, et al. · Eur Urol · 2022 · Derived
  6. INSIGHT 2: a phase II study of tepotinib plus osimertinib in MET-amplified NSCLC and first-line osimertinib resistance.
    F Smit E, Dooms C, Raskin J, et al. · Future Oncol · 2022 · Background
    PubMed: PMID 34918545 · NCT03940703 · Carcinoma, Non-Small-Cell Lung

2021 (2 papers)

  1. Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression.
    Ryoo BY, Cheng AL, Ren Z, et al. · Br J Cancer · 2021 · Trial result
    PubMed: PMID 33972742 · NCT01988493 · Carcinoma, Hepatocellular
  2. Phase 1b/2 trial of tepotinib in sorafenib pretreated advanced hepatocellular carcinoma with MET overexpression.
    Decaens T, Barone C, Assenat E, et al. · Br J Cancer · 2021 · Derived
    PubMed: PMID 33824476 · NCT02115373 · Carcinoma, Hepatocellular

2020 (2 papers)

  1. Tepotinib plus gefitinib in patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study): an open-label, phase 1b/2, multicentre, randomised trial.
    Wu YL, Cheng Y, Zhou J, et al. · Lancet Respir Med · 2020 · Trial result
    PubMed: PMID 32479794 · NCT01982955 · Carcinoma, Non-Small-Cell Lung
  2. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations.
    Paik PK, Felip E, Veillon R, et al. · N Engl J Med · 2020 · Trial result
    PubMed: PMID 32469185 · NCT02864992 · Carcinoma, Non-Small-Cell Lung

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).