Bayer's Nubeqa (darolutamide) reduced the risk of metastasis or death by 58% when added to hormone therapy and radiation in a Phase III trial involving prostate cancer patients at high risk of recurrence.
The findings, presented Saturday at the European Society for Medical Oncology (ESMO) congress, could potentially open another treatment setting for the oral androgen receptor inhibitor that generated sales of €2.4 billion ($2.7 billion) last year.
"These new data highlight the potential of [Nubeqa] to make a meaningful difference for patients earlier in the course of their prostate cancer," said Christine Roth, EVP for global product strategy and commercialisation at Bayer's pharmaceuticals division.
Nubeqa first won FDA approval in 2019 for non-metastatic prostate cancer that had become resistant to hormone suppression. Its label expanded in 2022 and 2025 to cover metastatic hormone-sensitive disease, first in combination with docetaxel and then without it.
Saturday's readout could support a fourth indication in patients with localised prostate cancer at very high risk of recurrence.
The DASL-HiCaP study enrolled 1106 patients who were randomly assigned to receive Nubeqa twice daily or placebo for 96 weeks, alongside standard-of-care androgen deprivation therapy (ADT) and radiation therapy (RT).
At a median follow-up of 3.8 years, the interim analysis showed Nubeqa significantly reduced the risk of metastasis or death compared with placebo (HR 0.42; p=0.0001) compared to placebo plus ADT and RT, meeting the trial's primary endpoint. Four-year metastasis-free survival reached 95% with Nubeqa versus 88% in the control group.
Nubeqa also reduced the risk of prostate-specific antigen progression or death (PSA-PFS) by 53%, with a four-year PSA-PFS rate of 91% versus 83% for placebo. However, an overall survival benefit has yet to be established, with four-year survival rates of 97% in the Nubeqa arm and 95% with placebo (HR 0.88). Bayer said OS follow-up is ongoing.
Meanwhile, grade 3 or higher adverse events occurred in 43% of patients receiving Nubeqa versus 36% in the control group, although Bayer said the drug's safety profile was consistent with its known tolerability.
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