IMPACT Therapeutics' Senaparib capsules have received marketing authorization from China's National Medical Products Administration (NMPA) for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube, or primary peritoneal cancer. This approval marks a significant advancement in the treatment landscape for ovarian cancer in China, offering a new option for patients who have achieved a complete or partial response following first-line platinum-based chemotherapy.
Senaparib, a novel and potent PARP 1/2 inhibitor discovered and developed by IMPACT Therapeutics, distinguishes itself with a unique molecular structure that provides high in vitro and in vivo activity, exceptional target selectivity, and a wide safety window. The approval is primarily based on the results of the Phase III FLAMES study, a randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of Senaparib as a monotherapy for maintenance treatment.
The FLAMES study demonstrated a statistically significant improvement in median progression-free survival (PFS) with Senaparib compared to placebo (PFS not reached vs. 13.6 months, HR 0.43, P < 0.0001), irrespective of BRCA status. This indicates a 57% reduction in the risk of progression or death. The study also highlighted a tolerable safety profile for Senaparib, with no new or unexpected safety concerns identified.
Efficacy Across HRD Status
An important aspect of the FLAMES study was the observation that both HRD-positive and HRD-negative patient populations derived benefit from Senaparib maintenance therapy. Among patients harboring BRCA mutations, the median PFS was not reached with senaparib vs 15.6 months with placebo (HR, 0.43; 95% CI, 0.24-0.76; P = .0026). For those with BRCA-negative disease, these respective figures were NR vs 12.9 months (HR, 0.43; 95% CI, 0.30-0.61; P < .0001). This broad applicability suggests that Senaparib has the potential to become a standard of care for first-line maintenance therapy in a wide range of patients with newly diagnosed ovarian cancer.
Ovarian Cancer Burden and Unmet Needs
Ovarian cancer remains a significant global health challenge. GLOBOCAN 2020 data indicates approximately 310,000 new cases and 210,000 deaths worldwide. In China, national cancer statistics from 2022 reported 61,100 new cases and 32,600 deaths, underscoring its status as a highly lethal gynecological malignancy. The insidious nature of ovarian cancer often leads to late-stage diagnosis in approximately 80% of patients, resulting in a 5-year survival rate of only 41.8%. While initial platinum-based chemotherapy can be effective, recurrence is common, highlighting the critical need for effective maintenance therapies.
Commercialization Strategy
In December 2023, IMPACT Therapeutics entered into a collaboration agreement with Zhongmei Huadong Pharmaceutical Co., Ltd, a subsidiary of Huadong Medicine Co., Ltd, for the commercialization of Senaparib in mainland China. Huadong Medicine will have exclusive promotion rights for Senaparib, leveraging its expertise in gynecological oncology. This partnership aims to provide comprehensive solutions for ovarian cancer patients at different stages of the disease, combining Senaparib with Huadong Medicine's existing portfolio, including mirvetuximab soravtansine-gynx (ELAHERE®).
Executive Perspective
Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT Therapeutics, expressed his enthusiasm for the approval, stating, "It is our great pleasure to share with you the successful approval of Senaparib for the Chinese market, which is another strong proof of the excellence of IMPACT's in-house synthetic lethality R&D platform and the R&D execution team. Leveraging Huadong Medicine's extensive commercial experiences in promoting novel therapeutics, we hope that Senaparib will reach more ovarian cancer patients soon and bring new treatment options for first-line maintenance therapy in advanced ovarian cancer."
