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Tepmetko

(Tepotinib)

ApprovedSmall molecule

Tepotinib is used to treat a specific type of lung cancer (non-small cell lung cancer) in patients whose cancer cells have a particular genetic mutation called METex14 skipping.[2] Tepmetko is currently approved and in use across 9 indications[4].[1]

Tepmetko is one of 297 small molecule programs targeting Colorectal Neoplasm. It is currently in Approved.

9

Indications

25

Total Trials

9

Active Trials

296

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

8

Patents

Pipeline

Status by Indication[4][1]

Indication

Colorectal NeoplasmApproved

Lung AdenocarcinomaApproved

Brain NeoplasmApproved

Liver DiseaseApproved

Non-Small Cell Lung CancerRecruiting

CancerRecruiting

PembrolizumabRecruiting

TrialRecruiting

Non-Small Cell Lung CarcinomaActive, not recruiting

Colorectal NeoplasmApproved

Approved

Lung AdenocarcinomaApproved

Approved

Brain NeoplasmApproved

Approved

Liver DiseaseApproved

Approved

Non-Small Cell Lung CancerPhase 3

Recruiting

CancerPhase 2

Recruiting

PembrolizumabPhase 1

Recruiting

TrialPhase 2

Recruiting

Non-Small Cell Lung CarcinomaApproved

Active, not recruiting

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Taxol

Tepmetko

Taxotere

Cytoxan

BBaxter Healthcare Corporation

Remeron

OOrganon and Co

Treatment

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

PD-1 Inhibitors

BBioNTech US Inc.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Cancer

NCT05159245

Q4 2027

Phase 2Recruiting

Trial

NCT02925234

PreclinicalActive, not recruiting

Non-Small Cell Lung Cancer

NCT06083857

Q2 2028

Phase 2Recruiting

Recurrent Lung Non-Small Cell Carcinoma

NCT06031688

Q3 2028

Phase 3Recruiting

Non-Small Cell Lung Cancer

NCT06908993

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated

Recruiting·IIntergroupe Francophone de Cancerologie Thoracique·Phase 3·NCT06908993·133 enrolled

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

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT07619339·16 enrolled

An Open-Label Phase I/II Study to Evaluate the Safety and prelimiBasnary Efficacy of Amivantamab and Tepotinib Combination in MET-altered Non-small Cell Lung Cancer (NSCLC)

Active, not recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06083857·3 enrolled

Show 1 more trial

A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT03940703·140 enrolled

Hepatocellular Carcinoma2 trials

c-Met Second-Line Hepatocellular Carcinoma

Completed· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT02115373·66 enrolled

Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma

Completed· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT01988493·117 enrolled

Interaction2 trials

Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05213481·18 enrolled

Tepotinib Drug-Drug Interaction Study With Itraconazole in Healthy Participants

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05203822·18 enrolled

Metastatic Colorectal Cancer1 trial

Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE)

Terminated· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT04515394·3 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

13 more indications

Pembrolizumab1 trial

POTENT - Tepotinib in Combination With Pembrolizumab in NSCLC

Recruiting·IInstitute of Cancer Research, United Kingdom·Phase 1·NCT05782361·19 enrolled

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Locally Advanced or Metastatic NSCLC1 trial

Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)

Completed· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT01982955·88 enrolled

Brain Tumors1 trial

A Phase 1a/1b Study to Determine the Recommended Phase 2 Dose, of Tepotinib in Participants With MET Alterations and Brain Tumors

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT05120960

NSCLC1 trial

CNS Dose Escalation/Expansion of Tepotinib in MET-driven NSCLC

Terminated·CCriterium, Inc.·Phase 1/2·NCT04739358·2 enrolled

Midazolam1 trial

Effect of Tepotinib on PK of CYP3A Substrate Midazolam

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03628339·12 enrolled

Solid Tumors1 trial

Tepotinib in Solid Tumors Harboring MET Alterations

Unknown status·—·Phase 2·NCT04647838·100 enrolled

Hepatic Impairment1 trial

Tepotinib Hepatic Impairment Trial

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 1·NCT03546608·18 enrolled

Cancer1 trial

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

Recurrent Lung Non-Small Cell Carcinoma1 trial

A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT06031688·56 enrolled

Non Small Cell Lung Cancer Metastatic1 trial

Lazertinib and Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment: A Phase II Multi-center Trial

Recruiting·SSamsung Medical Center·Phase 2·NCT06106802·47 enrolled

Non-small Cell Lung Cancer (NSCLC)1 trial

A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)

Active, not recruiting· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT02864992·337 enrolled

Unspecified3 trials

Effect of Tepotinib on the PK of the P-gp Substrate Dabigatran Etexilate

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03492437·20 enrolled

Effect of a Proton Pump Inhibitor on the PK of Tepotinib

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03531762·12 enrolled

Bioequivalence of 5 Tablets of 100 mg Versus 2 Tablets of 250 mg TF3 of Tepotinib

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT04204902·18 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 3, 2021

TEPMETKO

NDA NDA214096

Mar 23, 2023

TEPMETKO

NDA NDA214096

Mar 23, 2023

TEPMETKO

NDA NDA214096

Feb 15, 2024

TEPMETKO

NDA NDA214096

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Tepotinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tepmetko drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tepotinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tepotinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214096). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tepmetko. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Tepotinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — EMD Serono company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: MET Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: EMD Serono

Patent Landscape[6]

Patent Cliff

Apr 29, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9284300Apr 29, 2028

8921357May 30, 2028

8658643Jul 4, 2028

9403799Jul 4, 2028

9062029Jul 4, 2028

3 more patents

8927540Jul 21, 2028

8329692Oct 30, 2029

8580781Mar 19, 2030

Key Publications[7]

Tepotinib in MET Exon 14 Skipping NSCLC: VISION Extended

N Engl J MedSep 8, 2022DOI: 10.1056/NEJMoa2205855

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