Bayer's NUBEQA plus standard therapy cuts metastasis or death risk in high-risk prostate cancer
Interim results from the Phase III DASL-HiCaP trial showed that adding Bayer's NUBEQA to androgen deprivation therapy and radiation reduced the risk of metastasis or death by 58% versus placebo in prostate cancer patients at high risk of recurrence. Four-year metastasis-free survival was 95% with NUBEQA and 88% with placebo, while Grade 3 or higher adverse events were more common. The data were presented at ESMO 2026.
The DASL-HiCaP Phase III study, run by the ANZUP Clinical Trials Group, tested darolutamide (NUBEQA), an androgen receptor inhibitor, with androgen deprivation and locoregional radiation in patients at high recurrence risk. At a median 3.8 years, the interim analysis reported a hazard ratio of 0.42 (95% CI 0.27–0.66; p=0.0001) for metastasis or death versus placebo.
Four-year metastasis-free survival was 95% with darolutamide and 88% with placebo. Secondary findings included a 53% lower PSA-progression-or-death risk (HR 0.47; 95% CI 0.33–0.67) and four-year PSA-PFS of 91% versus 83%. Grade 3 or higher adverse events were more common. The data were presented at ESMO 2026.
If confirmed, adding darolutamide earlier could reduce metastatic spread and death for some high-risk prostate cancer patients, potentially easing treatment burden for patients and families. Clinicians may need to weigh the higher rate of serious adverse events against survival gains, and health systems could face increased use of an androgen receptor inhibitor alongside radiation. The findings may also inform shared decision-making for people facing recurrence risk, though longer follow-up and cost considerations could shape real-world access.