Adding Bayer’s androgen receptor inhibitor Nubeqa (darolutamide) to standard androgen deprivation therapy and locoregional radiation cut the risk of metastasis or death by 58 percent in men with prostate cancer at high risk of recurrence after curative-intent treatment, in the Phase 3 DASL-HiCaP trial presented at the ESMO Congress in Madrid on October 24. At a median follow-up of 3.8 years, the hazard ratio for metastasis-free survival on conventional imaging was 0.42 (95 percent confidence interval 0.27 to 0.66, p=0.0001), and 95 percent of Nubeqa patients remained free of metastasis at four years against 88 percent on placebo.
The trial, led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group with the University of Sydney, randomised 1,106 men across six countries. Patients took darolutamide 600 mg twice daily, or matching placebo, for 96 weeks, alongside a hormone therapy analogue for 96 weeks and radiation to the prostate or prostate bed and pelvic lymph nodes. Most received primary radiation and the remainder salvage radiation after prostatectomy. Secondary endpoints also favoured darolutamide, including prostate-specific antigen progression-free survival and time to castration resistance, according to the presentation summary.
Two limits define what this result is and is not. It is an interim analysis, triggered after 87 metastasis-free survival events, and overall survival was not significantly different between the arms at this look, with 21 deaths on darolutamide against 24 on placebo in the presentation summary. And Nubeqa is not yet approved in this localised, high-risk setting: its current labels cover non-metastatic castration-resistant and metastatic hormone-sensitive disease. A filing based on metastasis-free survival would test how regulators treat that endpoint in this population.
For Bayer and its development partner Orion, the commercial logic is scale. Earlier-stage prostate cancer is a far larger pool than the metastatic settings where Nubeqa already competes, and a 58 percent relative reduction, even on an interim look, is the kind of figure that supports a label-expansion filing rather than a niche add-on.