Capmatinib for metastatic NSCLCJune 10, 2020
Novartis announced that the US FDA approved capmatinib (Tabrecta), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test.
This indication is approved under accelerated approval based on overall response rate and duration of response.
The FDA also approved FoundationOne CDx as the companion diagnostic for capmatinib, to aid in detecting mutations that lead to MET exon 14 skipping in tumour tissue.
The approval is based on results from the pivotal GEOMETRY mono-1 phase II multi-centre, non-randomised, open-label, multi-cohort study. In the METex14 population (n=97), the confirmed overall response rate was 68% (95% CI, 48-84) and 41% (95% CI, 29-53) among treatment-naive (n=28) and previously treated patients (n=69), respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.11.
The trial evaluated 97 adult patients with metastatic NSCLC harbouring mutations that lead to METex14 (centrally confirmed) who were assigned to Cohorts 4 (n=69, previously treated patients) or 5b (n=28, treatment-naive), and received capmatinib tablets 400 mg orally twice daily.