The Food and Drug Administration (FDA) has granted accelerated approval to Tabrecta™ (capmatinib; Novartis) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
The approval of capmatinib, a kinase inhibitor that targets MET, was based on data from the multicenter open-label, multi-cohort phase 2 GEOMETRY mono-1 study that assessed the antitumor activity of capmatinib in 97 adult patients with metastatic NSCLC with confirmed MET exon 14 skipping. Patients received capmatinib 400mg orally twice daily until disease progression or unacceptable toxicity. The major efficacy outcome measures were overall response rate (ORR) determined by a blinded independent review committee using RECIST 1.1 and response duration.
Findings from the study showed a confirmed ORR of 68% (95% CI, 48-84) among 28 treatment-naive patients and 41% (95% CI, 29-53) among 69 previously treated patients. A median duration of response of 12.6 months (95% CI, 5.5–25.3) was observed among treatment-naive patients (19 responders) and 9.7 months (95% CI, 5.5-13.0) among previously treated patients (28 responders).
With regard to safety, the most common treatment-related adverse events (≥20%) included peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
Tabrecta will be available in the coming days as 150mg and 200mg tablets in 56-count bottles.
In addition, the FDA approved the FoundationOne®CDx (Foundation Medicine) assay as the companion diagnostic for Tabrecta to aid in detecting mutations that lead to MET exon 14 skipping in tumor tissue. FoundationOne®CDx is currently approved as the companion diagnostic test for 21 unique therapies.