Junshi Biosciences' Phase III clinical study of PARP inhibitor senaparib for first-line maintenance treatment of advanced ovarian cancer in the entire population has reached its primary endpoint

Beijing time on April 11, 2023, Junshi Biosciences announced that the polyadenosine diphosphate ribose polymerase (PARP) inhibitor senaparib (product code: JS109/IMP4297) developed by the company in cooperation with Inpace Pharmaceuticals is used for International Federation of Gynecology and Obstetrics (FIGO) stage III-IV epithelial cancer. A randomized, double-blind, placebo-controlled, multicenter Phase III clinical study (FLAMES study, NCT04169997) of maintenance therapy for patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who achieved complete or partial response to first-line platinum-containing chemotherapy has completed a prespecified interim analysis. The Independent Data Monitoring Committee (IDMC) determined that the primary endpoint of the study reached the preset superiority margin of the protocol. The company and its partner Yingpai Pharmaceutical will communicate with regulatory authorities in the near future to submit a new drug marketing application for this drug.

Dr. Jianjun Zou, President of Global R&D at Junshi Biosciences said: “As the first phase III clinical study of a domestic PARP inhibitor to obtain positive results for post-first-line maintenance treatment of advanced ovarian cancer, the interim analysis results of the FLAMES study showed that senaparib can significantly prolong the progression-free survival (PFS) of patients with advanced ovarian cancer, regardless of the patient’s Regardless of the breast cancer susceptibility gene (BRCA) mutation status, we will work with our partner Yingpai Pharmaceuticals to communicate with regulatory agencies, and we look forward to expanding our commercial oncology drug portfolio to bring better and more cost-effective treatment options to patients with advanced ovarian cancer."

Ovarian cancer is one of the most common fatal malignancies of the female reproductive tract. According to statistics, the number of new cases of ovarian cancer worldwide is approximately 310,000 annually, and the number of annual deaths from ovarian cancer is approximately 210,000 1 . Because the early symptoms of ovarian cancer are insidious and non-specific, about 80% of patients are diagnosed at an advanced stage, and the 5-year survival rate is only 40% 2 . Although ovarian cancer can go into remission after initial platinum-based chemotherapy, most patients inevitably face recurrence 3 . In recent years, PARP inhibitors are changing the treatment landscape of ovarian cancer, and their maintenance therapy can prolong the remission time after first-line platinum-containing chemotherapy and delay recurrence 4 .

【Reference】

1. Sung H, et al. CA Cancer J Clin. 2021; 71(3):209-49

2. Morgan RJ Jr, et al. J Natl Compr Canc Netw. 2016; 14:1134-63.

3. Jayson GC, et al. Lancet. 2014;384(9951):1376–88.

4. Khalique S, et al. Curr Opin Oncol. 2014;26(5):521–8.

5. This material is intended to convey cutting-edge information. It is not intended to promote any products to you and is not intended to serve as clinical medication guidance.

6. If you want to know more about the diagnosis and treatment of specific diseases, please follow the advice and guidance of medical and health professionals.

About the FLAMES study

The FLAMES study (NCT04169997) is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study designed to evaluate the efficacy and safety of senaparib single-agent maintenance therapy in patients with FIGO stage III-IV ovarian cancer after first-line platinum-containing chemotherapy achieves complete response (CR) or partial response (PR).

About Senaparib

Senaparib is a poly(ADP-ribose) polymerase (PARP) inhibitor. The clinical research of senaparib, a new type of targeted anti-cancer drug, received project support from the “Thirteenth Five-Year Plan” national major new drug creation project and successfully completed acceptance. In August 2022, the fixed-dose combination capsule of senaparib and temozolomide received orphan drug designation from the U.S. Food and Drug Administration for the treatment of adult patients with small cell lung cancer.

In August 2020, Junshi Biosciences and Yingpai Pharmaceuticals entered into a joint venture agreement to establish a joint venture. The joint venture will be mainly engaged in the research and development and commercialization of small molecule anti-tumor drugs including senaparib. Yingpai Pharmaceutical will inject the equity of senaparib in the joint venture area (Mainland China and Hong Kong and Macau Special Administrative Regions). Junshi Biosciences and Yingpai Pharmaceutical will each own 50% of the equity of the joint venture company.