Apollomics Announces the First Approval of Vebreltinib for MET Exon 14 Skip Non-Small Cell Lung Cancer
Apollomics’ partner, Avistone Biotechnology, received approval from Chinese National Medical Products Administration (NMPA) to commercialize vebreltinib (APL-101) in China
Compelling clinical data serving as basis of this approval supports continued development of vebreltinib for the rest of world
FOSTER CITY, Calif., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that its partner in China, Avistone Biotechnology Co. Ltd., received conditional approval from the National Medical Products Administration (NMPA) of China for the commercialization of vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC).
"The NMPA approval of vebreltinib is an important milestone toward providing a new treatment option for patients with MET exon 14 skipping NSCLC in China. Apollomics extends its full support and congratulations to Avistone on this significant achievement," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. "Our collaboration with Avistone and our ongoing global SPARTA trial with vebreltinib underscores our dedication to developing novel therapies for difficult to treat cancers and drug resistant patients worldwide."
Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-Met inhibitor. It 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. By targeting c-Met dysregulation, vebreltinib offers a potential breakthrough for patients with MET exon 14 skipping NSCLC and other cancers driven by c-Met alterations, i.e. exon 14 skipping, MET amplification, MET fusions.
In pursuit of the MET exon 14 skipping NSCLC indication, Apollomics is in active discussion with the U.S. Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for vebreltinib based on totality of clinical data from the global SPARTA trial and Avistone’s KUNPENG trial in China.
Under the partnership agreement, Avistone holds the exclusive rights to vebreltinib in China, Hong Kong and Macau, while Apollomics retains the exclusive rights in the rest of the world, including the U.S, and partners have access to each other’s data. This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.
Apollomics is conducting a multi-cohort Phase 2 study of vebreltinib, SPARTA, at over 90 centers in 13 countries investigating the efficacy and safety of vebreltinib in MET exon 14 skipping non-small cell lung cancer (NSCLC). Cohorts A-1 is recruiting in first line Met exon 14 skipping NSCLC subjects and Cohort A-2 is recruiting in pretreated (> 2L) MET exon 14 skipping NSCLC subjects. In addition, Cohort C includes histology agnostic cMet amplified cancers (excluding primary CNS tumors) and Cohort C-1 includes NSCLC harboring MET amplification and wild-type epidermal growth factor receptor (EGFR).
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