By Fineline Cube Beijing Avistone Pharmaceuticals Biotechnology Co., Ltd. announced that its subsidiary Pearl Bio’s c-MET inhibitor vebreltinib has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with MET amplification. This marks the third approved indication for the drug in China and represents the world’s first approved monotherapy indication for MET-amplified NSCLC patients.
Clinical Trial Results
The approval is based on results from the Phase II KUNPENG study, which demonstrated an overall objective response rate (ORR) of 48.8% and a disease control rate (DCR) of 77.9% among 86 patients. The median progression-free survival (PFS) was 7.4 months. Treatment-naive patients showed slightly better efficacy. Notably, for patients with brain metastases, the ORR reached 47.6%, indicating favorable central nervous system activity.
Previous Approvals
Vebreltinib was previously approved in China for the treatment of locally advanced or metastatic NSCLC with MET exon 14 skipping mutations. Additionally, it has been approved for adult patients with IDH-mutant astrocytoma (WHO Grade 4) with PTPRZ1-MET fusion genes who had failed prior treatment, or for glioblastoma with a history of lower-grade tumors.-Fineline Info & Tech