Adding Bayer’s prostate cancer drug NUBEQA (darolutamide) reduced the risk of metastasis or death by 58% in patients at high risk of recurrence, according to interim results from the Phase III DASL-HiCaP trial presented at the European Society for Medical Oncology (ESMO) Congress 2026.
The findings point to a potential advance in treating patients with high-risk localised prostate cancer, particularly those vulnerable to disease progression despite receiving treatment intended to cure the cancer.
After a median follow-up of 3.8 years, patients receiving NUBEQA alongside androgen deprivation therapy (ADT) and radiation therapy had a 58% lower risk of metastasis or death than patients receiving ADT, radiation and a placebo. The difference was statistically significant, with a hazard ratio of 0.42.
Four-year metastasis-free survival reached 95% among patients receiving NUBEQA, compared with 88% in the placebo group — a seven-percentage-point difference.
“Prostate cancer patients at a high risk of relapse face a considerable risk of recurrence and metastatic spread, making early, effective intervention vital,” said 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.”
The trial also reported improvements in a key secondary measure: prostate-specific antigen progression-free survival, which tracks disease progression through changes in prostate-specific antigen (PSA) levels.
NUBEQA reduced the risk of PSA progression or death by 53%, with a hazard ratio of 0.47. The four-year PSA progression-free survival rate was 91% in the NUBEQA group, compared with 83% in the placebo group.
However, the findings do not yet establish a significant overall survival benefit. Four-year prostate cancer-specific survival was 99% in both groups, while overall survival was 97% with NUBEQA and 95% with placebo. Follow-up is continuing to assess longer-term outcomes.
The safety profile of NUBEQA was consistent with previous studies, although the proportion of patients experiencing at least one Grade 3 or higher adverse event was greater in the NUBEQA group.
Such events occurred in 43% of patients receiving NUBEQA, compared with 36% of those receiving placebo.
Among Grade 2 or higher adverse events of special interest, fatigue or asthenia occurred in 14% of patients receiving NUBEQA versus 10% in the placebo group. Hypertension was reported in 7% versus 9%, fractures in 2% versus 3%, and cardiac events in 3% of both groups.
The results add to the evidence supporting the use of darolutamide across different stages of prostate cancer, although the drug's approved indications in the United States do not currently include this specific treatment setting.
“These new data underscore the potential of darolutamide to improve outcomes for patients in the early prostate cancer setting, adding to the broad body of evidence helping to support its use across different stages of the disease,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization at Bayer’s Pharmaceuticals Division.
“Bayer is proud to support research by ANZUP, the Sydney Clinical Trials Centre, Canadian Cancer Trials Group, and international partners, for men with prostate cancer.”
The investigator-initiated DASL-HiCaP trial, also known as ANZUP1801, enrolled 1,106 participants across Australia, New Zealand, Canada, the United States, Ireland and the United Kingdom.
Participants were randomly assigned to receive either NUBEQA at 600 mg twice daily or a matching placebo for 96 weeks. Both groups also received an LHRH analogue for 96 weeks and radiation therapy directed at the prostate or prostate bed and pelvic lymph nodes.
The trial's primary endpoint was metastasis-free survival assessed using conventional imaging. Secondary endpoints included PSA progression-free survival, prostate cancer-specific survival and overall survival.
The interim analysis was planned after 87 metastasis-free survival events. Longer-term follow-up is continuing, particularly to evaluate overall survival.
