NEW YORK – Avistone Biotechnology on Thursday said the National Medical Products Administration in China has approved the c-Met inhibitor vebreltinib for patients with IDH-mutant astrocytoma or low-grade glioblastoma characterized by a PTPRZ1-MET fusion gene after failure on prior treatments.
The NMPA had previously conditionally approved the treatment for patients with metastatic, MET exon 14 skipping non-small cell lung cancer. The regulatory agency approved the latest indication after reviewing results from the Phase I/II FUGEN clinical trial, in which patients with PTPRZ1-MET-altered brain cancers on vebreltinib had a median overall survival of 6.31 months compared to 3.38 months on the chemotherapy temozolomide or a combination of etoposide and cisplatin. Vebreltinib reduced the risk of death by 48 percent versus the comparator arm.
PTPRZ1-MET gene fusions occur in about 14 percent of glioblastoma patients in China who have a history of lower-grade disease, and the alteration often co-occurs with MET exon 14 skipping mutations. These alterations are associated with a poor prognosis. The prevalence of PTPRZ1-MET and MET exon 14 skipping alterations is less clear in US and European glioblastoma patients.
Avistone partnered with Apollomics to develop vebreltinib. Under the terms of their agreement, Avistone has rights to develop the drug in China, Hong Kong, and Macau, while Apollomics retains exclusive rights in the rest of the world, including the US. The companies are also sharing data with each other.
Apollomics is conducting its own clinical trial of vebreltinib. In the global Phase I/II SPARTA trial, which includes patients in Europe and the US, among 25 patients with relapsing, recurrent c-MET altered brain tumors, median overall survival was 6.5 months on vebreltinib. In eight patients with PTPRZ1-MET fusion-altered glioma, median overall survival was also 6.5 months. Based on those early results, Apollomics believes patients outside of China will respond similarly.
"The NMPA's approval of vebreltinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib's [central nervous system] penetration ability and c-Met inhibitor activity in the tumors there," Apollomics CEO and Chairman Guo-Liang Yu said in a statement.