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Therapeutic efficacy of Capmatinib

The approval of capmatinib is based on the results of the pivotal phase 2, multicenter, non-randomized, open-label, multi-cohort GEOMETRY mono-1 study. In the population with METex14 skipping mutations (n=97), according to the assessment by the blinded independent review committee based on the RECIST v1.1 criteria, the confirmed overall response rates were 68% (95% CI, 48–84) in treatment-naive patients (n=28) and 41% (95% CI, 29–53) in previously treated patients (n=69). The study also showed that the median duration of response was 12.6 months (95% CI, 5.5–25.3) among treatment-naive patients (19 responders) receiving capmatinib, and 9.7 months (95% CI, 5.5–13.0) among previously treated patients (28 responders). The most common treatment-related adverse events (incidence ≥20%) include peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

from FDA,2023.03

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