Apollomics Inc. announced that its partner in China, Avistone Biotechnology Co. Ltd. (Avistone), received approval from the National Medical Products Administration (NMPA) of China for vebreltinib (APL-101) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments. This supplemental New Drug Application (sNDA) approval makes vebreltinib the world's first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration, and follows the NMPA's November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).

The NMPA's approval of vebrelinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib's CNS penetration ability and c-Met inhibitory activity in the tumors there, said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. Vebreltinib, Apollomics' most advanced product candidate in the U.S., is a potent, small molecule, orally bioavailable and highly selective c-Met inhibitor that works by inhibiting the aberrant activation of the HGF/c-Met axis, a key pathway involved in tumor growth, proliferation, and the development of resistance to certain targeted therapies. The approval of vebreltinIB for the ZM fusion-positive glioma indication in China is based on the positive results of Avistone's FUGEN study (NCT06105619), a randomized, two-arm, multicenter Phase 2/3 clinical study that was conducted in China.

This 84-patient study compared the efficacy and safety of vebreltinib with the dose-dense regimen of temozolomide or the combination of etoposide and cisplatin, with OS as the primary endpoint.