China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced that the New Drug Application (NDA) for senaparib (JS109/IMP4297), a PARP inhibitor co-developed with compatriot firm Impact Therapeutics Inc., has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for use as a maintenance treatment in patients with stage III-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission after first-line platinum chemotherapy.
FLAMES Study Supports NDA Filing
The filing is supported by the FLAMES study, a randomized, double-blind, placebo-controlled, multi-center Phase III study. The study assessed the efficacy and safety of senaparib as a maintenance treatment for FIGO stage III-IV ovarian cancer patients with complete remission or partial remission following first-line platinum chemotherapy. Interim analysis results from the FLAMES study demonstrated that senaparib could significantly prolong the progression-free survival (PFS) of patients with advanced ovarian cancer, with benefits observed regardless of the breast cancer susceptibility gene (BRCA) status.
Orphan Drug Designation and Broadening Patient Population
Senaparib was awarded orphan drug designation status for use in small cell lung cancer combined with temozolomide in the US in August 2022. In the ovarian cancer field, the population sensitive to PARP inhibitors has expanded from BRCA mutant populations to HRD positive populations. Studies have shown that HRD negative populations are also expected to benefit from PARP inhibitor treatment, further expanding the potential patient base for senaparib.-Fineline Info & Tech
