De novo and acquired MET amplification in patients (pts) with non-small cell lung cancer (NSCLC) treated with tepotinib: Results from a real-world data analysis in Australia.

Abstract

Background: MET amplification (METamp) can develop as de novo or acquired resistance to tyrosine kinase inhibitor therapy in pts with NSCLC and actionable genomic alterations. Tepotinib is a highly selective oral MET kinase inhibitor that has shown promise in both settings. In Cohort B of the VISION study (data cutoff [DCO]: Aug 20, 2021), 24 pts with de novo METamp were treated with tepotinib; the overall response rate (ORR) was 41.7% (95% CI 22.1-63.4) and median progression-free survival (mPFS) was 4.2 mths (95% CI 1.4-15.6). In INSIGHT 2 (DCO: Mar 28, 2023), 98 pts with EGFR-mutant lung cancer and acquired METamp (in tissue by fluorescence in situ hybridization [FISH]) were treated with osimertinib and tepotinib; ORR was 50.0% (95% CI 39.7-60.3) and mPFS was 5.6 mths (95% CI 4.2-8.1). Here, preliminary data are presented from a real-world analysis of Australian pts with metastatic NSCLC and METamp in a cost-share program for tepotinib. Method(s): This is a retrospective analysis of adult pts with metastatic NSCLC with METamp detected by next-generation sequencing or FISH from the Australian costshare program for tepotinib from May 2023 to May 2025. Result(s): As of May 2025, 16 pts were enrolled in the cost-share program and received tepotinib. The table shows pt characteristics. In the de novo group (N=6), MET gene copy number (GCN) ranged from 3.9-20.0, ORR was 66.7%; median (range) duration of treatment (DoT) was 11 (2-26) mths; treatment (tx) is ongoing in 3 pts at DCO. In the acquired group (N=10), MET GCN was 3.9-14, ORR was 70.0%; median (range) DoT was 16 (3-24) mths; tx is ongoing in 5 pts. No new safety signals were seen in either group. Conclusion(s): Analysis of pts in the Australian cost-share program showed that tepotinib is an effective and tolerable tx in MET-amplified NSCLC. Editorial acknowledgement: Medical writing support was provided by Rebecca Yao, PhD, and Joyce Lee, PhD, of Nucleus Global, an Inizio company and was funded by Merck Healthcare Pty. Ltd., Macquarie Park, Australia, an affiliate of Merck KGaA.