Tepotinib Granted Breakthrough Therapy Designation in Subtype of Metastatic NSCLC
Posted: Monday, September 23, 2019
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation to the investigational targeted therapy tepotinib in patients with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations whose disease progressed after platinum-based therapy.
Tepotinib is an investigational oral MET kinase inhibitor that is designed to be selective and to inhibit the oncogenic signaling caused by MET gene alterations, including both MET exon 14 skipping alterations and MET amplifications, or MET protein overexpression.
The Breakthrough Therapy designation is based on data from the ongoing VISION study (ClinialTrials.gov identifier NCT02864992), which showed preliminary clinical evidence that tepotinib may offer an improvement over available therapy in patients with metastatic NSCLC harboring these genetic alterations detected by liquid biopsy or tissue biopsy across different lines of treatment. Results from the VISTION study were presented at the 2019 ASCO Annual Meeting (Abstract 9005).
Tepotinib is also being investigated in the INSIGHT 2 study (NCT03940703) in combination with the tyrosine kinase inhibitor osimertinib in EGFR-mutated, MET-amplified, locally advanced or metastatic NSCLC having acquired resistance to a prior EGFR tyrosine kinase inhibitor.