SUZHOU, China , and ROCKVILLE, Md. , June 11, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that the Center for Drug Evaluation (CDE) of China's National Medical Product Administration (NMPA) has approved a global registrational Phase III study of the company's novel drug candidate olverembatinib (HQP1351), in patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had failed prior systemic treatment.
This approval marks a major milestone in Ascentage Pharma's clinical development in solid tumors. This global, multicenter, single-arm, open-label, pivotal registrational Phase III study is designed to evaluate the efficacy and safety of olverembatinib in patients with SDH-deficient GIST. The CDE has agreed that results from the study can be used to support a future New Drug Application (NDA) for olverembatinib in SDH-GIST.
GIST is the most common type of soft tissue sarcoma that arises in the gastrointestinal track, with a global incidence of 1-1.5/100,000 per year. 1 KIT and PDGFRA are key genetic drivers of GIST, and 85% - 90% of all patients with GIST harbor KIT or PDGFRA mutations.
The introduction of tyrosine kinase inhibitors (TKIs) has improved the prognosis of patients with this subset of GIST. However, 85% of pediatric patients and 10%-15% of adult patients with GIST do not h.