NEW YORK – Apollomics said on Thursday that its c-MET inhibitor vebreltinib was approved by the National Medical Products Administration (NMPA) of China as a treatment for patients with MET exon 14 skipping non-small cell lung cancer.
The firm's partner, Avistone Biotechnology, holds exclusive rights to vebreltinib in China, Hong Kong, and Macau. Apollomics holds rights to the drug in the rest of world. Avistone conducted a Phase II trial of vebreltinib in Chinese patients with advanced MET exon 14 skipping NSCLC and published data earlier this year showing that 75 percent of patients responded to the treatment. Median progression-free survival was 14.1 months and median overall survival was 20.7 months.
Apollomics said it is in "active discussion" with the US Food and Drug Administration about submitting a new drug application (NDA) for vebreltinib in this same indication. The firm noted that the NDA submission to the FDA will include data from this Chinese study and from the global Phase II SPARTA trial. Last year, the FDA granted orphan drug designation to vebreltinib in this setting.
Apollomics, based in Foster City, California, went public earlier this year through a merger with a special purpose acquisition company, raising $23.65 million in private investment in public equity (PIPE) financing. The firm is also developing a pan-ErbB inhibitor APL-122 in ErbB1/2/4-positive solid tumors and several immuno-oncology therapies.