Bayer’s Nubeqa cuts risk of metastasis or death in prostate trial

Bayer ($BAYN) disclosed interim Phase 3 results showing that adding Nubeqa to hormone therapy and radiation reduced the risk of metastasis or death by 58% in prostate-cancer patients at high risk of recurrence. Four-year metastasis-free survival was 95%, compared with 88% for placebo alongside the same standard treatment. The investigator-led DASL-HiCaP trial randomized 1,106 participants and had median follow-up of 3.8 years.

The findings could support expansion into an earlier treatment setting beyond Nubeqa’s existing indications. However, an overall-survival benefit has not been established: the death-risk estimate had a wide confidence interval, and follow-up continues. Grade 3 or higher adverse events occurred in 43% of Nubeqa recipients versus 36% of controls. These are interim clinical results, with no new regulatory approval announced.

Sources:

• Business Wire
• stockwatch.com