The Chinese National Medical Products Administration (NMPA) has approved darolutamide (Nubeqa), an oral androgen receptor inhibitor (ARi), in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). This approval marks a significant advancement in the treatment landscape for prostate cancer in China, where the incidence of the disease has been rising.
Clinical Trial Data
The approval is based on the Phase III ARASENS trial, a randomized, double-blind, multi-center study. The trial compared darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel to ADT plus docetaxel in 1,306 newly diagnosed mHSPC patients. The primary endpoint was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), and time to initiation of subsequent anticancer therapy.
The ARASENS trial demonstrated that darolutamide plus ADT in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel alone (p<0.0001). The darolutamide combination also showed consistent benefits across clinically relevant secondary endpoints. The overall incidence of treatment-emergent adverse events was similar between treatment arms.
Darolutamide: Mechanism and Prior Approvals
Darolutamide is an oral androgen receptor inhibitor (ARi) that binds to the receptor with high affinity, inhibiting receptor function and the growth of prostate cancer cells. It exhibits a low potential for blood-brain barrier penetration, which is supported by preclinical models and neuroimaging data in healthy humans.
Nubeqa is already approved in more than 80 countries for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It is also approved for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in several markets, including the U.S., Japan, EU, and now China.
Impact on Prostate Cancer Treatment in China
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide. In China, prostate cancer cases have increased significantly in recent years, with nearly a third of newly diagnosed patients presenting with metastatic disease.
"We are therefore delighted that patients in China will now have a new treatment option for metastatic hormone-sensitive prostate cancer that delays disease progression, extends survival and maintains quality of life," said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology SBU at Bayer.
Ongoing Research
Darolutamide is being investigated in a broad development program with additional ongoing or planned clinical studies to evaluate its potential across prostate cancer patients from early- to late-stage disease. This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.
