Capmatinib Approved by FDA for Metastatic MET Exon 14–Mutated NSCLC
Posted: Friday, May 8, 2020
On May 6, the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor capmatinib (Tabrecta) for the treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) and specific mutations that can lead to MET exon 14 skipping. In addition, the FDA also approved the use of a companion diagnostic for capmatinib: the FoundationOne CDx assay (F1CDx). This next-generation sequencing is designed to detect mutations that lead to MET exon 14 skipping.
The FDA approval is based on the results of the GEOMETRY mono-1 multicenter, nonrandomized, open-label, multicohort trial. The study enrolled 97 patients with metastatic NSCLC: 69 patients had received prior treatment and 28 had not. All patients were administered a 400-mg oral dose of capmatinib twice daily until disease progression or unacceptable toxicity.
Previously untreated patients had an overall response rate of 68%, with 4% achieving a complete response and 64%, a partial response. Previously treated patients had an overall response rate of 41%, and all showed a partial response to capmatinib. In addition, the duration of response lasting at least 12 months was longer in patients who had never undergone NSCLC treatment compared with previously treated patients (47% vs. 32%).
Common side effects associated with capmatinib included peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. Serious side effects reported with the use of capmatinib were interstitial lung disease or pneumonitis.