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FDA Regular Approval of Capmatinib for MET Exon 14 Skipping NSCLC
August 2022: For adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation resulting in mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test, the Food and Drug Administration gave capmatinib (Tabrecta, Novartis Pharmaceuticals Corp.) regular approval.
Capmatinib was given fast approval for the same use on May 6, 2020, based on the overall response rate and length of response in the GEOMETRY mono-1 trial (NCT02414139), a multicenter, non-randomized, open-label, multi-cohort research study. Based on data from an additional 63 patients and an additional 22 months of follow-up to evaluate response durability and confirm therapeutic benefit, the conversion to regular approval was made.
GEOMETRY mono-1 Trial Efficacy and Patient Demographics
160 patients with advanced NSCLC with a mutation skipping exon 14 of MET showed efficacy. Patients received capmatinib 400 mg twice a day until their disease progressed or the side effects became intolerable.
A Blinded Independent Review Committee (BIRC) determined the ORR and duration of response (DOR) as the major efficacy measures (BIRC). 60 individuals who had never received treatment had an ORR of 68% (95% CI: 55, 80) and a DOR of 16.6 months (95% CI: 8.4, 22.1). The ORR was 44% (95% CI: 34, 54) among 100 patients who had previously received treatment, and the DOR was 9.7 months (95% CI: 5.6, 13).
The patients’ average age was 71 years (48 to 90). The following specific demographics were reported: 61% female, 77% were white, 61% never smoked, 83% had adenocarcinoma, and 16% had metastases to the central nervous system. 81% of patients who had previously had treatment had only gotten one line of systemic therapy; 16% had received two; and 3% had received three. 86% of patients who had previously had treatment had platinum-based chemotherapy.
Common Adverse Reactions and Recommended Dosage
Patients experienced edoema, nausea, musculoskeletal pain, weariness, vomiting, dyspnea, coughing, and decreased appetite the most frequently (20%).
Capmatinib should be taken orally twice daily at a dose of 400 mg, with or without meals.
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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