Capmatinib previously received accelerated approval, which was contingent upon further study results, for this indication in May 2020. The FDA’s decision to grant regular approval was based on new data from the GEOMETRY mono-1 trial, which included an additional 63 patients and 22 months of follow-up.
In the open-label, multicenter, non-randomized, phase 2 study, investigators demonstrated efficacy in 160 patients. During the trial, patients received 400 mg of capmatinib orally twice daily until disease progression or unacceptable toxicity.
Among 60 patients who hadn’t been treated, the overall response rate was 68% (95% CI, 55%-80%) with a duration of response of 16.6 months (95% CI, 8.4-22.1 months). Among 100 patients who received capmatinib as a second- or later-line therapy, the overall response rate was 44% (95% CI, 34%-54%) with a duration of response of 9.7 months (95% CI, 5.6-13 months).
The most common adverse reactions, occurring in at least 20% of patients, were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough and decreased appetite. Capmatinib also may cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. During the trial that led to the drug’s approval, ILD/pneumonitis occurred in 4.5% of patients treated with capmatinib.
For more details, see the full prescribing information for capmatinib.
MET exon 14 skipping mutations occur in approximately 3% to 4% of people with non-small cell lung cancer (N Engl J Med 2020;383[10]:944-957). Capmatinib offers a new treatment option for patients with this form of lung cancer, which is typically advanced, often associated with a poor prognosis and shows a limited response to standard therapies, Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne, Germany, and lead investigator of the GEOMETRY mono-1 trial, noted in a Novartis press release announcing the European Commission’s decision to approve the medication earlier this summer.
—Clinical Oncology News Staff
Based on press materials from the FDA and Novartis.