CHMP Backs Senaparib as First-Line Maintenance Therapy in Advanced Ovarian Cancer
核心洞察
The EMA's CHMP has adopted a positive opinion recommending marketing authorisation for Sepalna (senaparib) as maintenance treatment of advanced epithelial ovarian, fallopian tube and primary peritoneal cancer (搜索).
The opinion rests on the pivotal Phase III FLAMES trial, where senaparib cut the risk of progression or death by 57% versus placebo, with a hazard ratio of 0.43.
Median progression-free survival was not reached with senaparib versus 13.6 months with placebo at the prespecified interim analysis, with benefit seen irrespective of BRCA mutation status.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (搜索) has adopted a positive opinion recommending a Marketing Authorisation for Sepalna (senaparib) as maintenance treatment of advanced epithelial ovarian, fallopian tube and primary peritoneal cancer (搜索), IMPACT Therapeutics (搜索) and Pharmanovia announced on 18 September 2026.
The recommendation now goes to the European Commission for a final decision. If approved, senaparib would be authorised for marketing in all European Union member states and European Economic Area countries.
FLAMES Data Underpin the Opinion
The CHMP opinion is primarily based on the pivotal Phase III FLAMES study, a randomised, double-blind, placebo-controlled, multicentre trial. FLAMES evaluated senaparib against placebo as maintenance treatment in patients with advanced (FIGO Stage III-IV) ovarian cancer (搜索) who were in complete or partial response following first-line platinum-based chemotherapy.
At the prespecified interim analysis, median progression-free survival was not reached with senaparib versus 13.6 months with placebo (HR = 0.43, 95% CI 0.32-0.58; p<0.0001). Senaparib was associated with a 57% reduction in the risk of progression or death compared with placebo.
The benefit was observed in a broad patient population with advanced ovarian cancer (搜索) irrespective of BRCA mutation status, with consistent effects reported between homologous recombination subgroups.
Licensing and Commercial Footprint
IMPACT and Pharmanovia entered an exclusive partnership in July 2026. Under the licensing agreement, IMPACT granted Pharmanovia exclusive manufacturing, development and commercialisation rights for senaparib as maintenance monotherapy in advanced epithelial high-grade ovarian, fallopian tube and primary peritoneal cancer (搜索) across 66 countries. The territory covers all 27 EU member states plus the United Kingdom, Norway, Iceland, Switzerland, Liechtenstein, Australia, New Zealand and countries in the Middle East and North Africa.
"The positive opinion from EMA CHMP is a critical step towards market authorization by the EC, marking a significant milestone not only for senaparib and IMPACT Therapeutics (搜索), but also for the global footprint of innovative Chinese-originator biotech companies," said Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT. He added that the companies will work to advance access to senaparib across the licensed territories in Europe, the Middle East, North Africa, Australia and New Zealand.
Dr. Stephan Eder, Chief Executive Officer of Pharmanovia, said the partnership combines IMPACT's scientific expertise with Pharmanovia's launch and market expertise. "Our focus is now on using our market access, medical and launch capabilities to bring senaparib as a novel treatment option to patients in our territories," he said.
Mechanism and Prior Approvals
Senaparib (IMP4297) is a novel inhibitor of poly (ADP-ribose) polymerase (PARP (搜索)), classified under ATC code L01XK07. It blocks the repair of damaged DNA in cancer cells, causing the cancer cells to die. The product will be supplied as 20 mg hard capsules.
Senaparib capsules received approval from China's National Medical Products Administration in January 2025 as first-line maintenance therapy for adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (搜索) who achieve complete or partial response to platinum-based chemotherapy. The drug was subsequently included in China's National Reimbursement Drug List in December 2025, and has been reimbursable for ovarian cancer (搜索) first-line "all-comers" since 1 January 2026.
Disease Context
Ovarian cancer (搜索) is one of the most lethal malignancies affecting women, with a mortality rate among the highest for female cancers, and is the seventh most common cancer in women worldwide according to ESMO. Patients typically receive first-line systemic therapy at diagnosis, and those achieving complete or partial response generally enter the first-line maintenance phase as part of the standard treatment paradigm. First-line maintenance therefore represents the largest and most broadly applicable treated population within the overall ovarian cancer patient pool.
Epithelial ovarian cancer (搜索), the most frequent type, arises from a thin layer of cells on the ovarian surface or from the fallopian tube epithelium.
Pipeline Position
IMPACT Therapeutics (搜索), founded in 2009, describes itself as one of only three companies worldwide with both commercial-stage PARP1/2 inhibitors and clinical-stage next-generation PARP1-selective inhibitors. Beyond senaparib, its pipeline includes the PARP1-selective inhibitors IMP1734 and IMP1707, co-developed with Eikon Therapeutics (搜索), the ATR inhibitor IMP9064 and the WEE1 inhibitor IMP7068, alongside other synthetic lethality target inhibitors. The company also works across small molecules and emerging modalities including antibody-drug conjugates and degraders.