China’s NMPA has approved Bayer’s Nubeqa (darolutamide) plus ADT for metastatic hormone-sensitive prostate cancer based on Phase III ARANOTE trial results showing a 46% reduction in radiological progression or death.
Written By: Pharmacally Medical News Desk
China’s National Medical Products Administration (NMPA) has approved Bayer’s oral androgen receptor inhibitor Nubeqa™ (darolutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The approval represents an important advance for personalized prostate cancer care in China, where the disease burden continues to rise rapidly.
The decision is supported by strong results from the pivotal Phase III ARANOTE trial (NCT04736199). In the study, darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared with placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001).
Christine Roth, Executive Vice President at Bayer, highlighted the increasing prostate cancer burden in China and the need for more flexible treatment approaches. She noted that ARANOTE reaffirmed darolutamide’s efficacy, safety, and tolerability, and that the new approval allows physicians to use the regimen with or without chemotherapy, helping tailor treatment plans to individual patient needs.
ARANOTE Trial
ARANOTE (NCT04736199) is a randomized, double-blind, placebo-controlled Phase III trial evaluating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer. The study enrolled 669 patients, randomized 2:1 to receive darolutamide (600 mg twice daily) or placebo, both in combination with ADT.
The trial met its primary endpoint of improved radiological progression-free survival (rPFS). Findings presented at ESMO 2024 and later published in The Journal of Clinical Oncology demonstrated consistent rPFS benefits across prespecified subgroups, including patients with high-volume disease (HR 0.60) and low-volume disease (HR 0.30).
Secondary endpoints, including overall survival, PSA progression, and time to castration resistance, also supported the darolutamide-based regimen. The combination was generally well tolerated, with adverse event rates comparable to placebo and fewer treatment discontinuations due to side effects.
Professor Xing Nianzeng of the Cancer Hospital, Chinese Academy of Medical Sciences, emphasized that mHSPC represents a crucial treatment window and noted that ARANOTE offers an effective darolutamide-based option for patients who cannot or prefer not to receive chemotherapy.
About Darolutamide
Darolutamide is an oral androgen receptor inhibitor that binds strongly to the androgen receptor and blocks receptor-driven prostate cancer cell growth. Its unique chemical structure is associated with limited penetration across the blood-brain barrier, contributing to its favorable tolerability profile.
Developed jointly by Bayer and Orion Corporation, darolutamide continues to be evaluated across multiple stages of prostate cancer. Ongoing studies include the Phase III ARASTEP trial in high-risk biochemical recurrence and the Phase III DASL-HiCaP trial investigating darolutamide in localized prostate cancer alongside radiotherapy.
Prostate Cancer
Prostate cancer is the second most commonly diagnosed cancer in men worldwide, with approximately 1.5 million diagnoses and 397,000 deaths reported in 2022. In China, incidence and mortality are expected to increase further, with projections estimating more than 315,000 new cases and 81,000 deaths annually by 2030.
mHSPC remains a vital stage for early intensified treatment, as most patients ultimately progress to metastatic castration-resistant prostate cancer (mCRPC), which carries a poorer prognosis and limited survival outcomes.
References
Nubeqa™ (darolutamide) receives third approval in China for men with advanced prostate cancer, 03 February 2026, Nubeqa™ (darolutamide) receives third approval in China for men with advanced prostate cancer
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE), ClinicalTrials.gov ID NCT04736199, https://clinicaltrials.gov/study/NCT04736199
Saad F et al, Darolutamide in Combination with Androgen-Deprivation Therapy in Patients with Metastatic Hormone-Sensitive Prostate Cancer from the Phase III ARANOTE Trial. J Clin Oncol. 2024 Dec 20;42(36):4271-4281. Epub 2024 Sep 16. PMID: 39279580; PMCID: PMC11654448 https://doi.org/10.1200/jco-24-01798