Bayer, in collaboration with Orion Corporation, has submitted an application to China's National Medical Products Administration (NMPA) for approval of darolutamide (Nubeqa®) in combination with androgen deprivation therapy (ADT) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). This application marks a significant step toward expanding treatment options for prostate cancer patients in China.
The submission is based on data from the pivotal Phase III ARANOTE trial, a randomized, double-blind, placebo-controlled study involving 669 patients. The trial demonstrated that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR, 0.54; 95% CI, 0.41-0.71; P < .0001). At 24 months, the rate of rPFS was 70.3% in the darolutamide arm versus 52.1% in the placebo arm. The median rPFS was not reached in the darolutamide arm, compared with 25.0 months in the placebo arm.
Clinical Significance of ARANOTE Trial
The ARANOTE trial's results, presented at the 2024 European Society for Medical Oncology Congress and published in The Journal of Clinical Oncology, highlight the potential of darolutamide to improve outcomes for mHSPC patients. According to the authors, all subgroups derived benefit from treatment with darolutamide plus ADT. The hazard ratio (HR) for high-volume disease was 0.60 (95% CI, 0.44-0.80), and the HR for low-volume disease was 0.30 (0.15-0.60).
Darolutamide's Existing Approvals and Future Prospects
Darolutamide is already approved in over 80 markets, including China, for mHSPC in combination with ADT and docetaxel. It is also approved in more than 85 countries, including China, for non-metastatic castration-resistant prostate cancer (nmCRPC) patients at high risk of developing metastatic disease. Bayer is also seeking approval for darolutamide plus ADT without chemotherapy in mHSPC in the US and the EU. The FDA accepted the company’s supplemental new drug application for the indication in November 2024.
Safety and Tolerability
The ARANOTE trial indicated that darolutamide was well-tolerated. The incidence of treatment-emergent adverse events (TEAEs) was similar between the two groups, with TEAEs leading to permanent discontinuation of study drug occurring in 6.1% of patients in the darolutamide arm and 9.0% of patients in the placebo/ADT arm. No new safety signals emerged.
Prostate Cancer Landscape in China
Prostate cancer is a significant health concern in China, with prevalence projected to exceed 161,000 cases by 2026. Christine Roth, executive vice president at Bayer, emphasized the importance of diverse treatment options tailored to individual needs, stating, "Through this potential approval, we hope to be able to equip physicians in China with additional options to tailor treatment plans with or without chemotherapy."
