Multicenter phase 2 study of vebreltinib for advanced non-small cell lung cancer harboring c-Met exon 14 skipping mutation

Vebreltinib (also known as bozitinib, APL-101, PLB-1001, and CBT-101) is a potent and highly selective inhibitor of c-mesenchymal-epithelial transition (MET). Cohort 1 of the phase 2 KUNPENG study, at 17 centers in China, evaluated vebreltinib in patients with advanced non-small cell lung cancer (aNSCLC) harboring c-Met exon 14 skipping mutations. The cohort included 52 patients, of whom 35 (67%) were treatment-naïve. The objective response rate (primary endpoint) was 75% (95% CI 61.1-86.0) among all patients, 77.1% (59.9-89.6) among treatment-naïve patients, and 70.6% (44.0-89.7) among previously treated patients. The disease control rate was 96.2%, with a median duration of response of 15.9 months, a median progression-free survival of 14.1 months, and a median overall survival of 20.7 months. The most common treatment-related adverse events were peripheral edema (82.7% of patients), QT prolongation (30.8%), and elevated serum creatinine (28.8%). The authors conclude that vebreltinib has shown promising efficacy and a favorable safety profile in patients with METex14-mutant NSCLC.