Phase III clinical FLAMES Study of JS 109 completes interim analysis in ovarian cancer and meets efficacy target.- Shanghai Junshi Biosciences
Shanghai Junshi Biosciences announced that a randomized, double-blind, placebo-controlled, multi-center phase III clinical FLAMES Study (NCT04169997) investigating the poly (ADP-ribose) polymerase PARP inhibitor JS 109 (senaparib) had finished its pre-specified interim analysis
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 stage III/IV ovarian carcinoma, fallopian tube cancer or primary peritoneal cancer who achieved a complete response or partial response.
The Independent Data Monitoring Committee concluded that the primary endpoint had met the pre-defined efficacy boundary. Junshi Biosciences and IMPACT Therapeutics will communicate with regulatory authorities regarding a new drug application for the drug in the near future.
The FLAMES Study is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of senaparib as monotherapy maintenance treatment following first-line platinum-based chemotherapy in patients with FIGO stage III/IV ovarian cancer who have achieved complete response (CR) or partial response (PR).
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