October 12, 2021 (Shanghai, China) – Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the first patient in the U.S. had been dosed in a global Phase III study to evaluate fuzuloparib in combination with abiraterone acetate and prednisone (AA-P) as first-line treatment in patients with metastatic castration-resistant prostate cancer (mCRPC).

About the Study

SHR3162-III-305 (NCT04691804) is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate fuzuloparib in combination with AA-P in patients with mCRPC compared with placebo in combination with AA-P. The study is to enroll approximately 804 mCRPC patients from approximately 150 sites in 13 countries/regions (including the US, UK, France, Australia, South Korea, Spain, Belgium, etc.).

The primary endpoint is radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR). The secondary endpoints include overall survival (OS), objective response rate (ORR), time to prostate-specific antigen (PSA) progression, etc.

About Prostate Cancer

Prostate cancer is the second most common type of cancer in men and is the fifth leading cause of cancer mortality worldwide. According to the GLOBOCAN 2020 report, there were approximately 1.41 million new prostate cancer cases (comprising 14.1% of male cancer new diagnoses, after lung cancer which accounts for 14.3%) and approximately 380,000 prostate cancer deaths (comprising 6.8% of male cancer deaths) worldwide in 2020.

Data suggests that 10-20% of patients with prostate cancer metastasis develop CRPC within 5 years of follow-up, and that the median survival since development of castration resistance is approximately 14 months. Additionally, 15-33% of non-metastatic CRPC patients develop metastasis within 2 years, increasing the mortality burden in this population.¹

About Fuzuloparib

Fuzuloparib is a novel, potent, and orally active PARP inhibitor developed by Hengrui, which has been marketed in China for the treatment of ovarian cancer. Fuzuloparib received its first marketing authorization in Dec 2020 in China for the treatment of platinum-sensitive recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer in patients with germline BRCA mutation who have undergone second-line or above chemotherapy, and then received its second marketing authorization in Jun 2021 for the ≥2-line maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Consistent with high bioavailability observed in non-clinical studies, clinical data demonstrated a steady serum concentration, few gastrointestinal AEs in the severity of ≥Grade 3, and a low discontinuation rate due to AEs in patients receiving fuzuloparib. In addition, fuzuloparib is being evaluated for the treatment of other tumors, such as breast cancer, pancreatic cancer, triple-negative breast cancer (TNBC), and small cell lung cancer (SCLC).

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 21st among the top 1,000 global pharma companies in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.

1. Mansinho A., Macedo D., Fernandes I., Costa L. (2018) Castration-Resistant Prostate Cancer: Mechanisms, Targets and Treatment. In: Schatten H. (eds) Molecular & Diagnostic Imaging in Prostate Cancer. Advances in Experimental Medicine and Biology, vol 1126. Springer, Cham. https://doi.org/10.1007/978-3-319-99286-0_7

BD Contact

Email: bd@hengrui.com

Phone: +86-21-61053532