Efficacy and safety of tepotinib in Asian patients with advanced NSCLC with MET exon 14 skipping enrolled in VISION
Copyright policy )Efficacy and safety of tepotinib in Asian patients with advanced NSCLC with MET exon 14 skipping enrolled in VISION
Abstract Background Tepotinib, a MET inhibitor approved for the treatment of MET exon 14 (METex14) skipping NSCLC, demonstrated durable clinical activity in VISION (Cohort A + C; N = 313): objective response rate (ORR) 51.4% (95% CI: 45.8, 57.1); median duration of response (mDOR) 18.0 months (95% CI: 12.4, 46.4). We report outcomes in Asian patients from VISION (Cohort A + C) (cut-off: November 20, 2022). Methods Patients with advanced METex14 skipping NSCLC, detected by liquid or tissue biopsy, received tepotinib 500 mg (450 mg active moiety) once daily. Primary endpoint: objective response (RECIST 1.1) by independent review. Secondary endpoints included: DOR, progression-free survival (PFS), overall survival (OS), safety, and health-related quality of life (HRQoL). Results Across treatment lines in 106 Asian patients (39.6% female, 43.4% smoking history, 79.2% adenocarcinoma, 47.2% treatment-naive), ORR was 56.6% (95% CI: 46.6, 66.2), mDOR 18.5 months (10.4, ne), mPFS 13.8 months (10.8, 22.0), and mOS 25.5 months (19.3, 36.4). Consistent efficacy observed, regardless of baseline characteristics. HRQoL remained stable during treatment. Treatment-related adverse events (TRAEs) occurred in 95.3% of patients (39.6% Grade ≥3). Most common TRAEs: peripheral edema (62.3%), creatinine increase (38.7%). Conclusions Tepotinib demonstrated robust and durable efficacy, with a manageable safety profile, in Asian patients with METex14 skipping NSCLC. Clinical trial registration NCT02864992
- National Taiwan University of Arts Taiwan
- National Cancer Center Korea (Republic of)
- Memorial Sloan Kettering Cancer Center United States
- National Cancer Center United States
- Texas Medical Center United States
Male, Adult, Pulmonary and Respiratory Medicine, Lung Neoplasms, Pancreatic Cancer Research and Treatment, Advancements in Lung Cancer Research, Diagnosis and Treatment of Lung Cancer, 610, Nursing, FOS: Health sciences, Aged, 80 and over [MeSH] ; Asian People/genetics [MeSH] ; Carcinoma, Non-Small-Cell Lung/genetics [MeSH] ; Aged [MeSH] ; Lung Neoplasms/genetics [MeSH] ; Progression-Free Survival [MeSH] ; Proto-Oncogene Proteins c-met/genetics [MeSH] ; Piperidines [MeSH] ; Pyridazines [MeSH] ; /692/4028/67/1612/1350 ; Male [MeSH] ; Quality of Life [MeSH] ; /692/699/67/1612/1350 ; Exons [MeSH] ; Carcinoma, Non-Small-Cell Lung/pathology [MeSH] ; Female [MeSH] ; Adult [MeSH] ; Humans [MeSH] ; Middle Aged [MeSH] ; Article ; Pyrimidines/therapeutic use [MeSH] ; Pyrimidines/adverse effects [MeSH] ; Lung Neoplasms/pathology [MeSH] ; Carcinoma, Non-Small-Cell Lung/drug therapy [MeSH] ; Lung Neoplasms/drug therapy [MeSH] ; article, Adverse effect, Article, Asian People, Piperidines, Carcinoma, Non-Small-Cell Lung, Health Sciences, 80 and over, Medical Specialties, Medicine and Health Sciences, Humans, Clinical endpoint, Non-Small-Cell Lung, Internal medicine, Aged, Aged, 80 and over, Treatment Guidelines, Quality of life (healthcare), Carcinoma, Cohort, Exons, Middle Aged, Proto-Oncogene Proteins c-met, Progression-Free Survival, Pyridazines, Clinical trial, Pyrimidines, Oncology, Quality of Life, Medicine, Female, Surgery, Public Health
Male, Adult, Pulmonary and Respiratory Medicine, Lung Neoplasms, Pancreatic Cancer Research and Treatment, Advancements in Lung Cancer Research, Diagnosis and Treatment of Lung Cancer, 610, Nursing, FOS: Health sciences, Aged, 80 and over [MeSH] ; Asian People/genetics [MeSH] ; Carcinoma, Non-Small-Cell Lung/genetics [MeSH] ; Aged [MeSH] ; Lung Neoplasms/genetics [MeSH] ; Progression-Free Survival [MeSH] ; Proto-Oncogene Proteins c-met/genetics [MeSH] ; Piperidines [MeSH] ; Pyridazines [MeSH] ; /692/4028/67/1612/1350 ; Male [MeSH] ; Quality of Life [MeSH] ; /692/699/67/1612/1350 ; Exons [MeSH] ; Carcinoma, Non-Small-Cell Lung/pathology [MeSH] ; Female [MeSH] ; Adult [MeSH] ; Humans [MeSH] ; Middle Aged [MeSH] ; Article ; Pyrimidines/therapeutic use [MeSH] ; Pyrimidines/adverse effects [MeSH] ; Lung Neoplasms/pathology [MeSH] ; Carcinoma, Non-Small-Cell Lung/drug therapy [MeSH] ; Lung Neoplasms/drug therapy [MeSH] ; article, Adverse effect, Article, Asian People, Piperidines, Carcinoma, Non-Small-Cell Lung, Health Sciences, 80 and over, Medical Specialties, Medicine and Health Sciences, Humans, Clinical endpoint, Non-Small-Cell Lung, Internal medicine, Aged, Aged, 80 and over, Treatment Guidelines, Quality of life (healthcare), Carcinoma, Cohort, Exons, Middle Aged, Proto-Oncogene Proteins c-met, Progression-Free Survival, Pyridazines, Clinical trial, Pyrimidines, Oncology, Quality of Life, Medicine, Female, Surgery, Public Health
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