Hengrui's Class 1 new drug SHR3680 in the treatment of stage III prostate cancer reaches the primary research endpoint
July 17, 2021
Recently, Hengrui Medicine's Class 1 new drug SHR3680 combined with androgen deprivation therapy (ADT) compared to standard therapy combined with ADT for the treatment of high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC) is a multicenter, randomized, controlled phase III clinical study (study number) : SHR-3680-III-HSPC), the independent data monitoring committee (IDMC) determined that the intermediate analysis results of the primary endpoint of the radiological progression-free survival (rPFS) reached the pre-set superiority standard. Research results show that SHR3680 can significantly reduce the risk of disease progression or death in mHSPC patients with high tumor burden. The company will submit a pre-market communication application to the Drug Evaluation Center of the State Drug Administration in the near future.
About the SHR-3680-III-HSPC study
The SHR-3680-III-HSPC study is a multicenter, randomized, controlled phase III clinical study evaluating SHR3680 combined with ADT versus standard therapy combined with ADT for the treatment of mHSPC with high tumor burden. Professor Ye Dingwei from Fudan University Cancer Hospital serves as the main investigator , 50 centers in China and 22 centers in Eastern Europe (Poland, Czech Republic and Bulgaria) participated in the research. The study was launched in June 2018, and was randomly enrolled according to 1:1, enrolling a total of 654 subjects. The primary endpoints of the study include rPFS (based on the assessment of the independent review board) and overall survival (OS), and secondary endpoints include rPFS (based on the investigator's assessment), time to prostate specific antigen progression, and safety.
About prostate cancer
Prostate cancer is currently the world's second most common malignant tumor in male incidence and fifth in mortality. According to the GLOBOCAN 2020 report, there will be approximately 1.41 million new cases of prostate cancer worldwide in 2020 (accounting for 14.1% of all new malignant tumor cases in men, second only to 14.3% of lung cancer) and approximately 380,000 deaths (accounting for men) 6.8% of deaths from malignant tumors). The incidence of prostate cancer in China is significantly lower than that in Western countries, but it has shown a significant upward trend in recent years. In 2015, there were approximately 60 thousand new cases of prostate cancer in China and approximately 27,000 deaths. According to research data from the World Health Organization, in 2020, there were approximately 115,000 new cases of prostate cancer in China and approximately 51,000 deaths. The growth of prostate cancer cells is characterized by androgen dependence, so newly diagnosed metastatic prostate cancer is sensitive to ADT treatment (ie mHSPC). Recent studies have shown that a new type of androgen receptor (AR) antagonist combined with ADT in the treatment of mHSPC can effectively reduce the risk of disease progression or death and prolong OS. This study officially started in June 2018. At that time, there was no new AR antagonist approved for the treatment of mHSPC in China.
About SHR3680
SHR3680 is a new type of AR antagonist with independent intellectual property rights developed by Hengrui Medicine. Compared with the first generation of AR inhibitors, SHR3680 has a stronger AR inhibitory effect and no agonistic effect. In 2018, it was supported by the major new drug creation project of the Ministry of Science and Technology, and is currently in the late stage of clinical development. In addition to the SHR-3680-III-HSPC study that obtained a positive result of the rPFS interim analysis, there are also single drugs and combined docetaxel, etc. A number of phase II clinical studies for metastatic castration-resistant prostate cancer are ongoing.
