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

Safety and patient-reported outcomes with tepotinib in patients with METex14 skipping NSCLC: ≥3-year follow-up of VISION (125764)

Stephanie Gasking 1 , Enriqueta Felip 2 , Roberto Ferrara 3 , Remi Veillon 4 , Xiuning Le 5 , Egbert F. Smit 6 , Julien Mazières 7 , Alexis B. Cortot 8 , Jo Raskin 9 , Michael Thomas 10 , Niels Reinmuth 11 , James Chih-Hsin Yang 12 , Myung-Ju Ahn 13 , Jun Zhao 14 , Frank Griesinger 15 , Santiago Viteri 16 , Erica Velthuis 17 , Chris Pescott 18 , Andreas Johne 19 , Rolf Bruns 20 , Paul K Paik 21
  1. Merck Healthcare Pty. Ltd., Macquarie Park, Australia, an affiliate of Merck KGaA
  2. Department of Oncology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
  3. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano Università Vita-Salute San Raffaele Milano, Milan, Italy
  4. CHU Bordeaux, Service des Maladies Respiratoires, Bordeaux, France
  5. Department of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
  6. Department of Pulmonary Diseases, Leiden University Medical Centre, Leiden, The Netherlands
  7. CHU de Toulouse, Université Paul Sabatier, Toulouse, France
  8. Univ. Lille, CHU Lille, CNRS, Inserm, Institut Pasteur de Lille, UMR9020 – UMR-S 1277 - Canther, F-59000 Lille, France
  9. Department of Pulmonology and Thoracic Oncology, Antwerp University Hospital (UZA), Edegem, Belgium
  10. Department of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital and National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany; Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany
  11. Asklepios Clinics Munich-Gauting, Department of Thoracic Oncology, Gauting, Germany
  12. Department of Medical Oncology, National Taiwan University Cancer Center, Taipei, Taiwan
  13. Section of Hematology-Oncology, Department of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, South Korea
  14. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Thoracic Oncology, Peking University Cancer Hospital and Institute, Beijing , China
  15. Pius-Hospital, University Medicine Oldenburg, Department of Hematology and Oncology, University Department Internal Medicine-Oncology, Oldenburg , Germany
  16. Instituto Oncológico Dr Rosell, Hospital Universitario Dexeus, Grupo Quiron Salud, Barcelona, Spain
  17. Global Program Safety Lead, Merck B.V., Schiphol-Rijk, Netherlands , an affiliate of Merck KGaA
  18. Global Value Demonstration, Merck Healthcare KGaA, Darmstadt, Germany
  19. Global Clinical Development, Merck Healthcare KGaA, Darmstadt, Germany
  20. Department of Biostatistics, Merck Healthcare KGaA, Darmstadt, Germany
  21. Thoracic Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

Background: Patients with NSCLC harboring METex14 skipping are typically elderly with a poor prognosis, therefore treatments with a manageable safety profile are especially relevant. Tepotinib is an oral, highly selective MET TKI, approved in multiple countries for the treatment of advanced/metastatic NSCLC with METex14 skipping based on the outcomes from VISION study. Though safety outcomes and HRQoL PROs of tepotinib from VISION have previously been reported, here we report long-term safety outcomes and HRQoL PROs in patients with ≥3-year follow-up (data cut-off: May 20, 2024).

Methods: Patients with advanced EGFR/ALK wild-type NSCLC and METex14 skipping received tepotinib 500 mg (450 mg active moiety) QD until disease progression, intolerable toxicity, or withdrawal of consent. Secondary endpoints included safety and HRQoL, assessed using EORTC QLQ-C30 global health score (GHS), EQ-5D-5L visual analog scale (VAS), and EORTC QLQ-LC13 cough, dyspnea, and chest pain scores.

Results: 313 patients (median age: 72 years; ECOG 1, 73.8%) were evaluated for safety.

Safety outcomes included all-cause any grade AEs, 99.0% patients (Grade ≥3: 68.4%); any grade TRAEs, 91.7% patients (Grade ≥3: 36.1%); any grade serious TRAEs, 16.0% patients. The most common TRAE was peripheral edema, 67.7% (Grade ≥3: 11.8%).

In patients analyzed for HRQoL, mean change (±SD) from baseline for EORTC QLQ-C30 GHS was −7.1 (26.66) (n=174) and for EQ-5D-5L VAS was −10 (23.7) (n=172), with positive values indicating improvement. Similarly, EORTC QLQ-LC13 symptom scores for cough, dyspnea, and chest pain were −6.1 (28.16) (n=175), 7.1 (21.05) (n=175), and −2.3 (28.13) (n=174), respectively (negative values indicating improvement). Overall, HRQoL PROs remained stable during treatment with tepotinib.

Conclusions: Tepotinib demonstrated a continued manageable safety profile with no new safety signals, as well as stability in HRQoL PROs, consistent with earlier findings. These considerations support maximizing clinical benefits for this elderly patient population while maintaining their quality of life.