On June 30, Avistone’s independently developed MET inhibitor Vebreltinib received conditional approval from the National Medical Products Administration (NMPA) of China for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET amplification. This marks the third approved indication for Vebreltinib in China and the world’s first single-agent therapy approved specifically for MET-amplified NSCLC patients.
The approval of Vebreltinib in China for this new indication—treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET amplification—was based on the positive results from Cohort 2 and Cohort 3 of the KUNPENG study (NCT04258033).
Cohort 2 primarily enrolled previously treated patients with MET-amplified NSCLC who had failed standard therapy (including platinum-based chemotherapy), while Cohort 3 mainly included treatment-naïve patients with MET-amplified NSCLC who refused chemotherapy.
A total of 86 patients with locally advanced or metastatic NSCLC were enrolled across both cohorts (33 in Cohort 2 and 53 in Cohort 3). The study results showed an overall objective response rate (ORR) of 48.8%, disease control rate (DCR) of 77.9%, median duration of response (DoR) of 12.1 months, median progression-free survival (PFS) of 7.4 months, and median overall survival (OS) of 13.9 months.
In Cohort 2 (33 previously treated patients), the ORR was 48.5%, DCR was 78.8%, median DoR was 11.0 months, median PFS was 6.2 months, and median OS was 11.7 months.
In Cohort 3 (53 treatment-naïve patients), the ORR was 49.1%, DCR was 77.4%, median DoR was 12.1 months, median PFS was 8.3 months, and median OS was 15.5 months.
In the KUNPENG study, 21 patients with baseline brain metastases were assessed by Independent Review Committee (IRC). Among these, 10 achieved confirmed partial responses (PR), resulting in an ORR of 47.6%, DCR of 85.7%, and median DoR of 11.0 months. Additionally, the median PFS and OS were 8.3 months and 14.7 months, respectively.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
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Post time: Jul-08-2025