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Poster display - Cocktail

945 - Tepotinib in non-small cell lung cancer (NSCLC) with MET-exon 14 skipping mutations (METex14+) and MET amplification (METamp); a phase 2 trial in progress


24 Nov 2018


Poster display - Cocktail


Cytotoxic Therapy;  Translational Research

Tumour Site


Paul Paik


Annals of Oncology (2018) 29 (suppl_9): ix150-ix169. 10.1093/annonc/mdy425


P. Paik1, H. Sakai2, R. Bruns3, J. Scheele4, J. Straub5, E. Felip6

Author affiliations

  • 1 Thoracic Oncology Service, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
  • 2 Department Of Thoracic Oncology, Saitama Cancer Center, Saitama/JP
  • 3  biostatistics, Merck KGaA, Darmstadt/DE
  • 4  clinical Oncology, Merck KGaA, Darmstadt/DE
  • 5 Global Early Development, Merck KGaA, 64293 - Darmstadt/DE
  • 6 Oncology Department, Vall D'Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona/ES

Abstract 945


The Met pathway is frequently deregulated in human cancer, leading to dependency on Met signaling and hence this represents a potential therapeutic target in NSCLC. MET alterations include MET-exon 14 skipping mutations (METex14+) and MET amplification (METamp); these occur in ∼3% and 0.4–4% of NSCLCs, respectively. Tepotinib is a potent and highly selective, small molecule inhibitor of Met.

Trial design

This single-arm, open-label, multicenter phase 2 trial will assess the efficacy and safety of tepotinib, 500 mg once-daily as 1st–3rd line of treatment, in patients with histologically confirmed, Stage IIIB/IV NSCLC harboring either METex14 + (Cohort A, detected in tumor [TBx] and/or plasma [liquid biopsy; LBx] samples) or METamp (Cohort B). Patients with epidermal growth factor receptor (EGFR)-activating mutations or anaplastic lymphoma kinase (ALK) rearrangements are excluded. Enrollment into Cohort A began in September 2016 and recruitment into this cohort is ongoing. In Cohort B, patients will initially be enrolled based on METamp via LBx. The primary endpoint is objective response rate (ORR) assessed by an independent review committee (IRC)- via Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints include investigator-assessed ORR, and investigator/IRC-assessed duration of response, disease control, progression-free survival, and overall survival. The tolerability and safety of tepotinib will also be assessed as secondary objectives in this patient population.

Editorial acknowledgement

Dawn Batty.

Clinical trial identification


Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany.


Merck KGaA, Darmstadt, Germany.


H. Sakai: BMS, Ono, MSD, Chugai, Eli Lilly, AstraZeneca. R. Bruns: Employment: Merck KGaA, Darmstadt, Germany; Shares: Merck. J. Scheele, J. Straub: Employment: Merck KGaA, Darmstadt, Germany. E. Felip: Speaker’s bureau and Advisory board in relation to: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celegene, Eli Lilly, Guardant Health, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Abbvie, Merck. All other authors have declared no conflicts of interest.

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