Efficacy and safety of tepotinib in Asian patients with advanced NSCLC with MET exon 14 skipping enrolled in VISION Journal Article
| Authors: | Kato, T.; Yang, J. C. H.; Ahn, M. J.; Sakai, H.; Morise, M.; Chen, Y. M.; Han, J. Y.; Yang, J. J.; Zhao, J.; Hsia, T. C.; Berghoff, K.; Bruns, R.; Vioix, H.; Lang, S.; Johne, A.; Le, X.; Paik, P. K. |
| Article Title: | 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 © The Author(s) 2024. |
| Keywords: | adult; cancer survival; controlled study; human tissue; treatment response; aged; aged, 80 and over; middle aged; major clinical study; overall survival; exon; genetics; exons; clinical trial; advanced cancer; diarrhea; drug dose reduction; drug efficacy; drug safety; drug withdrawal; cancer patient; follow up; cancer diagnosis; progression free survival; quality of life; controlled clinical trial; phase 2 clinical trial; anemia; nausea; carcinoma, non-small-cell lung; lung neoplasms; cohort analysis; smoking; creatinine; creatinine blood level; tumor biopsy; pathology; pyrimidines; alanine aminotransferase blood level; aspartate aminotransferase blood level; gamma glutamyl transferase blood level; lung tumor; alanine aminotransferase; alkaline phosphatase; aspartate aminotransferase; hypoalbuminemia; hyponatremia; lung adenocarcinoma; multicenter study; peripheral edema; open study; alkaline phosphatase blood level; piperidines; leukocyte count; pyrimidine derivative; gamma glutamyltransferase; amylase blood level; triacylglycerol lipase blood level; japan; taiwan; amylase; china; triacylglycerol lipase; scatter factor receptor; non small cell lung cancer; progression-free survival; asian; decreased appetite; proto-oncogene proteins c-met; piperidine derivative; clinical outcome; patient-reported outcome; met protein, human; south korea; very elderly; humans; human; male; female; article; exon skipping; liquid biopsy; tepotinib; european organization for research and treatment of cancer quality of life questionnaire core 30; treatment response time; pyridazine derivative; pyridazines; asian people |
| Journal Title: | British Journal of Cancer |
| Volume: | 130 |
| Issue: | 10 |
| ISSN: | 0007-0920 |
| Publisher: | Nature Publishing Group |
| Date Published: | 2024-06-01 |
| Start Page: | 1679 |
| End Page: | 1686 |
| Language: | English |
| DOI: | 10.1038/s41416-024-02615-9 |
| PUBMED: | 38575731 |
| PROVIDER: | scopus |
| PMCID: | PMC11091176 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
