Your Health, We Care
Release date: 2024-11-25 15:19:11 Recommended: 117
MET dysregulation occurs in up to 26% of patients with non-small cell lung cancer (NSCLC) after treatment with epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs). Capmatinib (INC280), a highly potent and selective MET inhibitor, has demonstrated significant preclinical activity in an acquired EGFR-TKI resistance model with EGFR mutation, MET amplification/overexpression when used in combination with gefitinib. This study aims to investigate the safety and efficacy of capmatinib in combination with gefitinib in patients with EGFR-mutated, MET dysregulated (including amplified/overexpressed) NSCLC who have progressed on prior EGFR-TKI therapy.
In the Phase Ib phase, patients are treated with Capmatinib capmatinib at doses ranging from 100 to 800 mg capsules once daily or 200 to 600 mg capsules or tablets twice daily supplemented with 250 mg gefitinib once daily. Upon entry to stage II, patients receive the recommended phase II dose. The primary endpoint of the study was overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
A total of 61 patients with stage Ib and 100 patients with stage II were included in this study. After evaluation, the recommended phase II dose is Capmatinib 400 mg twice daily in combination with 250 mg gefitinib once daily. Preliminary clinical observations showed an overall response rate (ORR) of 27% for Phase Ib/II. The efficacy is even more pronounced in patients with tumors with highly amplified MET, especially when the MET gene copy number is ≥6, and the ORR of stage II is as high as 47%.
In terms of safety, the most common drug-related adverse events in patients with stage Ib and II included nausea (28%), peripheral edema (22%), decreased appetite (21%), and rash (20%). The most common drug-related grade 3/4 adverse events were elevated levels of amylase and lipase, both in 6%. Notably, no significant drug interactions were observed between Capmatinib and gefitinib.
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