China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has declared that the Phase III FLAMES study for senaparib (JS109/IMP4297), a PARP inhibitor co-developed with Impact Therapeutics Inc., has achieved the pre-set optimal efficiency threshold, marking the trial’s primary endpoint. The study targets the first-line maintenance treatment for stage III/IV ovarian cancer, and preparations for a New Drug Application (IND) filing are currently underway.
Landmark Phase III Study for Homegrown PARP Inhibitor
The randomized, double-blind, placebo-controlled, multi-center Phase III study is the first of its kind for a domestically developed PARP inhibitor as a first-line maintenance treatment for ovarian cancer to report positive outcomes. The study aims to evaluate the safety and efficacy of senaparib as a maintenance treatment for patients with Stage III/IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete response (CR) or partial response (PR) after first-line platinum-containing chemotherapy. Interim analysis results from the FLAMES study indicated that senaparib significantly extended the progression-free survival (PFS) of patients with advanced ovarian cancer, with benefits observed across all breast cancer susceptibility gene (BRCA) status groups.
Joint Venture and Orphan Drug Designation
In August 2020, Junshi and Impact established an equally shared joint venture (JV) focused on the research, development, and commercialization of small molecule anti-tumor drugs, including senaparib. Impact contributed the rights for the drug in mainland China, Hong Kong, and Macau, which are part of the joint venture area. In August 2022, senaparib received orphan drug designation status in the US for use in combination with temozolomide for the treatment of small cell lung cancer.-Fineline Info & Tech
