Pharma Focus Asia
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Apollomics Receives Approval in China for Vebreltinib, a Novel Treatment Targeting Gliomas with MET Fusion Gene

Friday, April 26, 2024

Apollomics Inc. (Nasdaq: APLM) has announced a significant development regarding vebreltinib (APL-101) in China. The National Medical Products Administration (NMPA) has granted approval to Avistone Biotechnology Co. Ltd., Apollomics' partner, for the use of vebreltinib in treating adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma who have the PTPRZ1-MET fusion (ZM fusion) gene and have previously failed treatments.

This approval marks vebreltinib as the first c-Met inhibitor globally approved for treating Central Nervous System (CNS) tumors with c-Met alterations. Previously, the NMPA approved vebreltinib in November 2023 for treating patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).

Apollomics, emphasized the significance of this approval, highlighting vebreltinib's penetration into the CNS and its inhibitory activity against c-Met in tumors. He also stressed the collaboration with Avistone and the ongoing global SPARTA trial as evidence of their commitment to developing vebreltinib for patients globally with solid tumors harboring c-Met alterations.

Gliomas present significant treatment challenges, constituting a considerable portion of intracranial tumors. Current standard treatments offer limited success, with poor prognoses and low overall survival rates. Notably, about 12% of gliomas in Chinese patients exhibit MET fusion, with the ZM fusion being a common subtype associated with a poorer prognosis.

Vebreltinib, Apollomics' leading product candidate in the U.S., is a potent, orally bioavailable c-Met inhibitor. It works by disrupting the aberrant activation of the HGF/c-Met axis, a pivotal pathway in tumor growth and resistance to targeted therapies.

The approval in China was based on positive results from Avistone’s FUGEN study (NCT06105619), which demonstrated vebreltinib’s efficacy and safety in comparison to standard treatments. Notably, vebreltinib showed a significant improvement in overall survival for patients with recurrent relapsing ZM fusion glioma.

In addition to their partnership in China, Apollomics retains exclusive rights to vebreltinib in the rest of the world, including the U.S. The ongoing global SPARTA study further investigates vebreltinib’s efficacy and safety in various settings, providing promising preliminary data supporting its potential as a global treatment option for patients with c-Met alterations.



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