Phase III data for darolutamide shows a 58% reduction in metastasis risk for high-risk prostate cancer patients, bolstering the clinical outlook for partners Orion and Bayer.
Orion Corporation's share price is bolstered by the positive Phase III DASL-HiCaP trial results, which demonstrated a 58% reduction in the risk of metastasis or death when using darolutamide in high-risk prostate cancer patients. As the original discoverer of the drug, these results validate the expansion of darolutamide into the early prostate cancer treatment setting, representing a significant potential market growth opportunity.
The primary endpoint was metastasis-free survival based on conventional imaging (MFS-CI).
At a median follow-up of 3.8 years, the trial showed a 58% reduction in the risk of metastasis or death compared to placebo.
Bayer, as the global commercialization partner for darolutamide (Nubeqa), benefits directly from the clinical success of the DASL-HiCaP trial. The data provides a strong clinical foundation to seek label expansion for Nubeqa into early-stage prostate cancer, which would significantly increase the drug's addressable patient population and long-term revenue potential.
Yes, Nubeqa is approved in over 85 markets for the treatment of mHSPC and nmCRPC.
The safety profile was consistent with known tolerability, with adverse events similar to the placebo group.
Orion Corporation and Bayer announced positive Phase III DASL-HiCaP trial results showing that darolutamide, when combined with standard ADT and radiation therapy, reduces the risk of metastasis or death by 58% in high-risk prostate cancer patients. The study, presented at the ESMO Congress 2026, demonstrated a 95% metastasis-free survival rate at four years, marking a significant clinical milestone for the co-developed drug.
The trial provides evidence that adding darolutamide to standard-of-care therapy significantly improves outcomes for patients with prostate cancer at high risk of recurrence, potentially expanding the drug's clinical utility.
Darolutamide is developed jointly by Orion Pharma and Bayer as a global commercialization partnership.