MET Inhibitor Capmatinib Granted FDA Priority Review in Advanced Lung Cancer
Posted: Wednesday, February 19, 2020
On February 11, Novartis announced that the U.S. Food and Drug Administration (FDA) granted a Priority Review designation for the MET inhibitor capmatinib for patients with MET exon 14 skipping (METex14)-mutated advanced non–small cell lung cancer (NSCLC). This mutation occurs in reportedly 3% to 4% of patients with newly diagnosed advanced NSCLC.
This designation is based on the GEOMETRY mono-1 phase II trial results. This study enrolled 334 treatment-naive and previously treated patients with NSCLC. In treatment-naive patients, the response rate was 67.9%, with a median duration of response of 11.1 months. In contrast, previously treated patients had a response rate of 40.6%, with a median duration of response of 9.7 months.
The most common treatment-related adverse events across all cohorts of patients included peripheral edema (42%), nausea (33%), creatine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%), and diarrhea (11%). Most adverse events were grade 1 or 2.
