Shanghai Junshi Biosciences announced that Phase 3 FLAMES study of Senaparib had finished its pre-specified interim analysis

The Independent Data Monitoring Committee concluded that the primary endpoint of progression-free survival (PFS) had met the pre-defined efficacy boundary

Senaparib was jointly developed by Junshi Biosciences and IMPACT Therapeutics as a maintenance treatment following first-line platinum-based chemotherapy in patients with International Federation of Gynecology and Obstetrics (“FIGO”) stage III/IV ovarian carcinoma, fallopian tube cancer or primary peritoneal cancer who achieved a complete response or partial response

Companies will communicate with regulatory authorities regarding the NDA for the drug in the near future

“As the first phase III clinical study of a domestically developed PARP inhibitor that has achieved positive results for advanced ovarian cancer maintenance treatment following first-line therapy, the FLAMES study’s interim analysis results show that senaparib can significantly extend the progression free survival (PFS) of patients with advanced ovarian cancer, regardless of the patient’s breast cancer susceptibility gene (BRCA) mutation status.” Said Dr. Jianjun ZOU, President of Global R&D, Junshi Biosciences