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ESMO 2026: NUBEQA® (darolutamide) Plus ADT and Radiation Therapy Reduces Risk of Metastasis or Death by 58% in Prostate Cancer Patients at High Risk of Recurrence

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  • Interim analysis results from the Phase III DASL-HiCaP trial show a statistically significant 58% reduction in the risk of metastasis or death with NUBEQA® (darolutamide) versus placebo in addition to androgen deprivation therapy (ADT) and radiation therapy (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001)

  • Four-year metastasis-free survival rate in trial reached 95% with NUBEQA compared to 88% with placebo, alongside secondary endpoint improvements and a safety profile consistent with previous studies

  • Results will be presented as a late-breaking abstract in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026

WHIPPANY, N.J., October 24, 2026--New late-breaking data to be presented today by the Australian and New Zealand Urogenital and Prostate (ANZUP) Clinical Trials Group at the European Society for Medical Oncology (ESMO) Congress 2026 will show that adding Bayer's androgen receptor inhibitor (ARi), NUBEQA® (darolutamide), to standard-of-care androgen deprivation therapy (ADT) and locoregional radiation therapy (RT), improves metastasis-free survival based on conventional imaging (MFS-CI) in prostate cancer patients with high risk of recurrence compared to placebo. These data will be presented at Presidential Symposium I at the ESMO Congress 2026 (LBA4, Saturday, October 24, at 16:30 CEST/10:30 am ET).

NUBEQA is indicated in the U.S. for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC) both with and without docetaxel, and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1

At a median follow-up of 3.8 years, the interim analysis demonstrated a statistically significant 58% reduction in the risk of metastasis or death with NUBEQA plus ADT and RT compared with placebo plus ADT and RT (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001).2 The 4-year metastasis-free survival rate was 95% for patients receiving NUBEQA compared with 88% for those receiving placebo.2

"Prostate cancer patients at a high risk of relapse face a considerable risk of recurrence and metastatic spread, making early, effective intervention vital," said Dr. Tamim Niazi, Associate Professor of Oncology at McGill University, Radiation Oncologist at the Jewish General Hospital in Montreal, Canada, and Co-Lead Investigator of the study. "The improvement in metastasis-free survival seen in interim results from the DASL-HiCaP trial highlights the potential of adding darolutamide to standard androgen deprivation therapy and radiation therapy to help prevent or delay disease progression in patients who are at high risk of progression despite receiving primary curative therapy."

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