FDA Approval Insights: Tepotinib in METex14-Altered Metastatic NSCLC

Welcome to OncLive On Air^TM! I’m your host today, Jessica Hergert.

OncLive On Air^TM is a podcast from OncLive, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

Today, we had the pleasure of speaking with Paul K. Paik, MD, clinical director of the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center, to discuss the FDA approval of tepotinib (Tepmetko) for patients with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations.

On February 3, 2021, the FDA granted an accelerated approval to tepotinib based on data from in the phase 2 VISION trial (NCT02864992), which showed that the MET inhibitor induced an objective response rate of 43% among 69 treatment-naïve patients per blinded independent review committee using RECIST v1.1 criteria. Moreover, the median duration of response with the agent was 10.8 months.

Regarding safety, the most frequently reported adverse effects with tepotinib included edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. The FDA notes that the agent can also lead to interstitial lung disease, hepatotoxicity, and embryo-fetal toxicity.

In our exclusive interview, Paik provided perspective on the FDA approval of tepotinib in MET exon 14-altered metastatic NSCLC.