IMPACT THERAP-B (07630): Senaparib receives positive CHMP opinion, expected to be used for first-line maintenance treatment of advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer

IMPACT THERAP-B (07630) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorisation (MA) for Sepalna (senaparib), intended for the maintenance treatment of advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. Following the CHMP's recommendation for approval, senaparib will be referred to the European Commission (EC) for a final decision. Once approved by the European Commission, senaparib will be authorised for marketing in all EU member states and European Economic Area countries. The positive opinion from the CHMP was primarily based on results from the pivotal Phase III FLAMES study. The FLAMES study is a multicentre, randomised, double-blind, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of senaparib versus placebo as maintenance treatment in patients with advanced (FIGO Stage III-IV) high-grade epithelial ovarian cancer (OC), fallopian tube cancer, and primary peritoneal cancer who achieved response (complete response or partial response) following first-line (1L) platinum-based chemotherapy. In the FLAMES study, senaparib as 1L maintenance monotherapy reduced the risk of disease progression or death compared with placebo in a broad population of patients with advanced ovarian cancer, regardless of BRCA mutation status, with consistent benefit observed across homologous recombination subgroups. Notably, in the prespecified interim analysis, median progression-free survival had not yet been reached in the senaparib group versus 13.6 months in the placebo group (hazard ratio = 0.43, 95% confidence interval 0.32-0.58; p<0.0001). Compared with placebo, senaparib reduced the risk of disease progression or death by 57%. The above FLAMES study results were published in *Nature Medicine* in May 2024. Dr. Cai Suixiong, Chief Executive Officer of the Company, stated: "The positive opinion from the EMA CHMP is a key step towards marketing authorisation by the European Commission. This is an exciting and important milestone for senaparib as a drug, for Impact Therapeutics itself, and for the internationalisation of China's independently developed innovative drugs. We very much look forward to the EC's final approval decision and will continue to work closely and efficiently with our partner Pharmanovia to fully advance the accessibility of senaparib in the licensed territories of Europe, the Middle East, North Africa, and Australia and New Zealand, accelerating this China-originated innovative drug's journey to the global stage to benefit more patients worldwide." Dr. Stephan Eder, Chief Executive Officer of Pharmanovia, added: "This collaboration combines Impact Therapeutics' scientific expertise with our commercial launch and market operations experience. The CHMP's positive opinion marks an important next step in the regulatory process for this drug. Our current focus is to leverage our market access, medical affairs, and commercial launch capabilities to provide patients in the licensed territories with senaparib as a new treatment option."