SHANGHAI, China, April 11, 2023 -- IMPACT Therapeutics, Inc. (“IMPACT Therapeutics”), announced that a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (“FLAMES Study”, NCT04169997) investigating the poly (ADP-ribose) polymerase (“PARP”) inhibitor, senaparib (product code: IMP4297), had finished its pre-specified interim analysis. Senaparib was independent research and developed by IMPACT Therapeutics, Inc. (“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. The Independent Data Monitoring Committee (the “IDMC”) concluded that the primary endpoint had met the pre-defined efficacy boundary. IMPACT Therapeutics will communicate with regulatory authorities in collaboration with our partner Junshi Biosciences regarding a new drug application for the drug in the near future.
Dr. Suixiong CAI, the Chief Executive Officer of IMPACT Therapeutics, commented on the positive results of the FLAMES study. "We are extremely proud of the results archieved by Senaparib in clinical research. This is the fruit of the persistent and continuous efforts of IMPACT therapeutics team over the years, which also validated our scientific research capabilities. We will communicate with regulatory agencies in collaboration with our partner Junshi Biosciences, and strive to provide this important treatment option to patients as soon as possible”.
Ovarian cancer is one of the most commonly fatal malignant tumors affecting the female genital tract. According to GLOBOCAN 2020 data, around 310,000 new cases of ovarian cancer are diagnosed across the world annually, resulting in roughly 210,000 deaths every year. As the early symptoms of ovarian cancer are hidden and non-specific, around 80% of the patients with ovarian cancer are diagnosed at an advanced stage, with a five-year survival rate of only 40%. Although primary platinum-based chemotherapy can help alleviate ovarian cancer, most patients inevitably experience cancer relapse. Over the years, PARP inhibitor has revolutionized the treatment of ovarian cancer. In particular, PARP inhibitor maintenance treatment can extend the response time following first-line platinum-based chemotherapy and delay cancer relapse.
About the FLAMES Study
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).
As a novel targeted anti-tumor drug, senaparib is a PARP inhibitor. The clinical study of senaparib was supported by the national special project for innovative manufacturing of major new drugs under the 13th Five-Year Plan, and the inspection and acceptance procedures were completed smoothly. In August 2022, the fixed dose combination capsules of senaparib and temozolomide for the treatment of adult patients with small cell lung cancer was granted orphan-drug designation by the U.S. Food and Drug Administration.
About IMPACT therapeutics
IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. Impact has assembled one of the most comprehensive DNA damage response (DDR) global pipeline of novel drug candidates generated by in-house discovery efforts and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT pipeline products include PARP inhibitor (senaparib/ IMP4297), Wee1 inhibitor (IMP7068), and other novel DDR pathway inhibitors.