Poster Presentation 2025 Joint Meeting of the COSA ASM and IPOS Congress

Tepotinib in patients with MET exon 14 (METex14) skipping non-small cell lung cancer (NSCLC) from the VISION study: ≥3-year follow-up outcomes (125723)

Stephanie Gasking 1 , Julien Mazières 2 , Remi Veillon 3 , Alexis B. Cortot 4 , Roberto Ferrara 5 , Enriqueta Felip 6 , Marina Chiara Garassino 7 , Xiuning Le 8 , Michael Thomas 9 , Hiroshi Sakai 10 , Egbert F. Smit 11 , Jo Raskin 12 , Santiago Viteri 13 , James Chih-Hsin Yang 14 , Myung-Ju Ahn 15 , Yi-Long Wu 16 , Jun Zhao 17 , Vishal Ghori 18 , Rolf Bruns 19 , Andreas Johne 20 , Paul K. Paik 21
  1. Merck Healthcare Pty. Ltd., Macquarie Park, Australia, an affiliate of Merck KGaA
  2. CHU de Toulouse, Université Paul Sabatier, Toulouse, France
  3. CHU Bordeaux, Service des Maladies Respiratoires, Bordeaux, France
  4. Univ. Lille, CHU Lille, CNRS, Inserm, Institut Pasteur de Lille, UMR9020 – UMR-S 1277 - Canther, F-59000 Lille, France
  5. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano Università Vita-Salute San Raffaele Milano, Milan, Italy
  6. Department of Oncology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
  7. Department of Medicine, Section of Hematology/Oncology, Knapp Center for Biomedical Discovery, The University of Chicago, IL, USA
  8. Department of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
  9. Department of Thoracic Oncology, Thoraxklinik and National Center for Tumor Diseases at Heidelberg University Hospital, Heidelberg, Germany; Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL)
  10. Department of Thoracic Oncology, Ageo Central General Hospital, Saitama, Japan
  11. Department of Pulmonary Diseases, Leiden University Medical Centre, Leiden, The Netherlands
  12. Department of Pulmonology and Thoracic Oncology, Antwerp University Hospital (UZA), Edegem, Belgium
  13. Instituto Oncológico Dr Rosell, Hospital Universitario Dexeus, Grupo Quiron Salud, Barcelona, Spain
  14. Department of Medical Oncology, National Taiwan University Cancer Center, Taipei, Taiwan
  15. Section of Hematology-Oncology, Department of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, South Korea
  16. Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China
  17. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology, Peking University Cancer Hospital and Institute, Beijing, China
  18. Ares Trading SA, Eysins, Switzerland, an affiliate of Merck KGaA
  19. Department of Biostatistics, Merck Healthcare KGaA, Darmstadt, Germany
  20. Global Clinical Development, Merck Healthcare KGaA, Darmstadt, Germany
  21. Thoracic Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

Background: Tepotinib, a highly selective MET inhibitor, has demonstrated robust and durable efficacy and safety in patients with METex14 skipping NSCLC in Cohorts A+C (data cut-off: Nov 20, 2022; follow-up: Cohort A >35 months, Cohort C >18 months) and in patients with high-level MET amplification (METamp) NSCLC in Cohort B of the Phase II VISION study (NCT02864992). We report long-term efficacy and safety outcomes from VISION in patients with ≥3-year follow-up (data cut-off: May 20, 2024).

Methods: Patients with advanced NSCLC and METex14 skipping or METamp received tepotinib 500 mg (450 mg active moiety) QD. Primary endpoint was objective response (Independent review using RECIST v1.1). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.

Results: Of 313 patients enrolled in Cohorts A+C (male: 49.2%; median age: 72 years; ECOG PS 1: 73.8%; smoking history: 47.6%), the median duration of treatment was 7.5 months, and treatment was ongoing in 18 patients (first-line [1L]: 12/164; second-or-later line [2L+]: 6/149). Overall, objective response rate (ORR) was 51.8% (95% CI: 46.1, 57.4), mDOR was 18.0 months (12.6, 31.8), mPFS was 11.2 months, and mOS was 19.7 months.

In 1L patients, ORR was 57.9%, mDOR was 31.7 months, mPFS was 12.6 months, and mOS was 21.1 months, while in 2L+ patients, ORR was 45.0%, mDOR was 12.6 months, mPFS was 11.0 months, and mOS was 19.3 months. No new safety concerns were observed. Grade ≥3 TRAEs occurred in 36.1% patients, while 15.7% patients discontinued treatment due to TRAEs.

Long-term outcomes from Cohort B will also be presented.

Conclusions: Tepotinib continued to demonstrate robust and durable activity across treatment lines. Importantly, outcomes in patients with METex14 skipping were consistent with previous results, reinforcing tepotinib as a meaningful treatment option in this setting.