Approximately 85% of newly diagnosed advanced ovarian cancer may experience a relapse after the first line (1L) platinum-based chemotherapy. Over time, PARP inhibitors have brought about a significant transformation in the management of ovarian cancer. Notably, the use of PARP inhibitor maintenance therapy has the potential to prolong the duration of response after initial platinum-based chemotherapy and delay cancer relapse. 

Impact Therapeutics’ Senaparib is a novel, highly potency PARP inhibitor that has demonstrated significantly improved PFS over placebo, irrespective of BRCA mutation status in a Phase III FLAMES trial evaluating the efficacy and safety of the drug 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). Senaparib led to 57% risk reduction in progression or death with senaparib (p <0.0001). At 12 months, the PFS rate in the senaparib arm was 72.2% vs 53.7%, and at 24 months it was 63.0% vs 31.3%. All secondary endpoints showed the superiority of senaparib.

 

The rates of severe adverse events (AEs) were 66.3% compared to 20.3%, AEs leading to a reduction in dose were 63.3% vs 6.0%, and discontinuation due to AEs was 4.4% vs 0% in the Senaparib and placebo arms, respectively. These results mark a significant step forward in offering improved prospects for patients facing this challenging condition, with the potential for broader treatment applicability.

KOL insights

“The results support senaparib as a maintenance treatment for patients with advanced ovarian cancer after a response to first-line chemotherapy. Senaparib demonstrated a tolerable safety profile with a very low incidence of permanent discontinuation and no significant safety concerns observed. ” –Associate Professor, Japan

Conclusion 

Results from the Phase III FLAMES study unveil Senaparib maintenance therapy as a major advancement in the treatment of advanced ovarian cancer. It delivered an exceptional reduction in the risk of disease progression when compared to a placebo among a diverse group of patients with newly diagnosed advanced ovarian cancer, irrespective of their BRCA mutation status. This PFS benefit was consistently observed in all predefined subgroups, indicating the broad efficacy of senaparib. This breakthrough not only offers hope to a broader spectrum of individuals but also underlines senaparib's excellent safety and tolerability profile with very few instances of treatment discontinuation and no significant safety concerns. The drug demonstrated a favorable non-hematological safety profile, making it a promising option for improving outcomes in the battle against this challenging disease. 

In September 2023, Impact Therapeutics announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Senaparib in China, as a first-line maintenance treatment of adult patients with ovarian epithelial carcinoma, fallopian tube cancer or primary peritoneal cancer following a response to platinum-based chemotherapy. In addition, 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 US Food and Drug Administration (FDA). There is a growing competition in maintenance settings in Ovarian Cancer. In the China market, there are numerous PARPi that have been approved by the NMPA for the maintenance of ovarian cancer. These include GSK's ZEJULA (niraparib) and AstraZeneca's LYNPARZA (olaparib), Hengrui's AiRuiYi (fuzuloparib) and BeiGene's PARTRUVIX (pamiparib). Senaparib is expected to face stiff competition from established players in the ovarian cancer market. On 22 September 2022, AstraZeneca and MSD’s LYNPARZA (olaparib) was approved in China. On December 27, 2019, Zai Lab Limited announced the China NMPA approved the NDA for ZEJULA (niraparib), as maintenance therapy. 

DelveInsight estimates that the total incident population of ovarian cancer in the 7MM will reach ~46,000 in 2032. Estimates show that the highest incident population of ovarian cancer is in the United States followed by Japan, Germany, and the UK.

For more insight into the patient's burden/epidemiology, treatment, and changing market landscape-related advancements, refer to the Ovarian Cancer Market Forecast Report