On September 7, 2021 Jiangsu Hengrui Pharmaceuticals Co., Ltd. reported that the China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for SHR3680 in the treatment of metastatic hormone‑sensitive prostate cancer (mHSPC) with high tumor burden (Press release, Hengrui Pharmaceuticals, SEP 7, 2021, View Source [SID1234633499]). The BTD will expedite the development and the following new drug application (NDA) review of this next-generation androgen receptor (AR) antagonist.
The BTD is supported by the latest positive interim data from the Phase III SHR‑3680‑III-HSPC study, a multicenter, randomized, and active-controlled clinical trial evaluating the efficacy and safety of SHR3680 in combination with androgen deprivation therapy (ADT) in mHSPC patients with high tumor burden. The primary endpoint, radiographic progression‑free survival (rPFS) evaluated by Independent Data Monitoring Committee (IDMC), was met. The interim analysis demonstrated that SHR3680 significantly reduced the risk of disease progression or death in mHSPC patients with high tumor burden.

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About the Study

The Phase III SHR-3680-III-HSPC study enrolled 654 patients who were randomized 1:1 to receive either SHR3680 plus ADT or standard of care (SoC) plus ADT from 50 sites in China and 22 sites in East Europe (Portland, Czech Republic, and Bulgaria). This study was initiated in June 2018, and Professor Dingwei Ye from Fudan University Shanghai Cancer Center is the Leading Principal Investigator. The primary endpoints include rPFS based on IDMC evaluation and overall survival (OS). The secondary endpoints include rPFS based on investigator evaluation, time to prostate specific antigen (PSA) progression, safety‑related endpoints and 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. The incidence of prostate cancer in China is lower than that in Western countries, but it has significantly increased in recent years. In 2015, there were approximately 60,000 new prostate cancer cases and approximately 27,000 prostate cancer deaths in China. However, in 2020, there were approximately 115,000 new prostate cancer cases and approximately 51,000 prostate cancer deaths in China, according to World Health Organization.

About SHR3680

SHR3680 is a proprietary next-generation AR antagonist developed by Hengrui, which is currently in the late stage of clinical development. SHR3680 demonstrated significantly lower extent of brain penetration in pre-clinical studies, which potentially reduces the risks for seizure. Clinical data to date supports this potential advantage over the 2nd‑generation AR antagonists. In addition to the SHR-3680-III-HSPC study which showed positive interim rPFS analysis results, there are multiple SHR3680 clinical studies ongoing to investigate single agent or combination with other drugs (such as docetaxel) in metastatic castration‑resistant prostate cancer.