The Phase III ARANOTE trial has demonstrated significant benefits for NUBEQA (darolutamide) in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study met its primary endpoint of extended radiological progression-free survival (rPFS) compared to placebo plus ADT.
NUBEQA, an androgen receptor inhibitor, has shown a clinically meaningful increase in rPFS, indicating a delay in tumor growth and spread. The results align with its established safety profile, with no new safety concerns identified.
The study included 669 patients randomized to receive either NUBEQA or placebo twice daily in addition to ADT. The primary endpoint was the time until disease progression or death.
In addition to rPFS, the study also assessed other outcomes such as overall survival, time to treatment failure, and quality of life. Detailed results are expected to be presented at a future scientific conference.
“These positive Phase III results provide physicians with more options to tailor treatment plans for patients with mHSPC,” said Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division.
Bayer plans to submit the data to the U.S. FDA for regulatory approval, expanding the potential use of NUBEQA in the treatment of prostate cancer.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
