Capmatinib: 68% ORR secured regular FDA approval

On August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib (Tabrecta) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.

The regular approval comes following the accelerated approval that FDA granted on May 6, 2020, based on the GEOMETRY mono-1 trial. Moving to regular approval was supported by data from an additional 63 patients, as well as an additional 22 months of follow-up time to assess the durability of response and verify clinical benefit.

The median age of patients was 71 years (48 to 90). Selected demographics were reported as follows: 61% female, 77% White, 61% never smoked, 83% had adenocarcinoma, and 16% had CNS metastases. Among previously treated patients, 81% received one, 16% received two, and 3% received three prior lines of systemic therapy. Amongst previously treated patients, 86% received prior platinum-based chemotherapy.

Results among 60 treatment-naïve patients showed 68% (95% CI: 55, 80) ORR with a DOR of 16.6 months (95% CI: 8.4, 22.1). While, for the 100 previously treated patients, ORR was 44% (95% CI: 34, 54) with a DOR of 9.7 months (95% CI: 5.6, 13).

On a safety level, the most common adverse reactions (≥20%) in patients were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.