marked.bio

MET TKI · small molecule

tepotinib

5 active trials across 3 of our biomarkers, targeting MET. 2 active approvals for a biomarker on marked.bio.

Also known as MSC2156119J, Tepmetko.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
tepotinib
FDA, 2021
metastatic, MET exon 14 skipping Accelerated approval 03/02/2021; traditional approval 15/02/2024. Source
EU (EMA), 2022
advanced, METex14 skipping, needing systemic therapy after immunotherapy and/or platinum chemotherapy EU marketing authorisation 16/02/2022. Source
Tepmetko 		MET exon 14 skipping NSCLC Approved 2021 Approved 2022

In the FDA approval summary

VISION single-arm, 164 untreated; 149 previously treated
Response 57% (untreated); 45% (previously treated) (49-65; 37-53)Lasting 40% and 36% of responses lasted 12 months or more

Trial details and side effects
Patients
MET exon 14 skipping metastatic NSCLC (NCT02864992)
Most common side effects
oedema, nausea, fatigue, musculoskeletal pain, diarrhoea, dyspnoea, decreased appetite, rash
Notes
FDA approval summary (2024); side effects are those in 20% or more of patients.
Source
FDA approval summary

In the EU summary (EPAR)

VISION single-arm, 138 previously treated
Response 44%Lasting more than 11 months on average

Trial details and side effects
Patients
MET exon 14 skipping metastatic NSCLC (NCT02864992)
Most common side effects
oedema, nausea, fatigue, musculoskeletal pain, diarrhoea, dyspnoea, decreased appetite, rash
Notes
EU figures from the EPAR summary; trial details and side effects from the US approval.
Source
EU summary (EPAR)

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
MET exon 14 skipping 4 8 Phase 1/2
EGFR exon 19 deletion / L858R 1 4 Phase 2
ALK fusion 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of tepotinib.

  1. Merck KGaA 1

Trials

5 of 11 trials shown

  1. Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment

    Recruiting Phase 2 Sehhoon Park Started 2024Primary completion 2029-09 NCT06106802

    lazertinib FDA EUtepotinib

    Confirmed EGFR mutations (exon 19 deletion, L858R) with acquired resistance after first-line lazertinib treatment (either partial re…

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer Metastatic

  2. PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer

    Active, not recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2024Primary completion 2027-12 NCT06083857

    amivantamabtepotinib FDA EU

    NSCLC which harbors MET Exon 14 skipping alterations detected in the tissue or ctDNA (safety cohort and cohort A \[MET ex…

    MET exon 14 skippingNon-small Cell Lung Cancer

  3. Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)

    Recruiting Phase 2 SWOG Cancer Research Network Started 2024Primary completion 2028-05 NCT06031688

    ramucirumabtepotinib FDA EU

    Participants must have documentation of stage IV or recurrent NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA \[ctDN…

    MET exon 14 skippingRecurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

  4. Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

    Active, not recruiting Phase 2 Merck KGaA Started 2016Primary completion 2022-05 NCT02864992

    tepotinib FDA EU

    Participants with MET alterations, namely METex14 skipping alterations in plasma and/or tissue as determined by the central laboratory or b…

    MET exon 14 skippingAdvanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification, Lung Adenocarcinoma Stage IIIB/IV

  5. A Study of Tepotinib and Ivonescimab in People With Non-Small Cell Lung Cancer

    Recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2026Primary completion 2029-05 NCT07619339

    tepotinib FDA EUivonescimab

    Patients must have documentation of MET exon 14 skipping present in their cancer using an FDA-approved assay done within a laboratory wit…

    MET exon 14 skippingNon-Small Cell Lung Cancer