Bayer's New Drug Nubeqa Significantly Extends Survival Time for Prostate Cancer Patients

On November 21, 2024, Bayer announced that a Supplemental New Drug Application (sNDA) for its product darotamine (trade name: Nubeqa) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) has been accepted by the U.S. Food and Drug Administration (FDA).

The sNDA application is based on the positive results of the Phase III ARANOTE study. The study was a randomized, double-blind, placebo-controlled clinical trial (n=669) designed to evaluate the efficacy and safety of darotamine (600mg twice daily) in combination with ADT compared with placebo and ADT in the treatment of patients with mHSPC. The primary endpoint of the study was radiologic progression-free survival (rPFS) at 36 months.

The results showed that patients in the darotamine group had significantly longer rPFS than those in the placebo group (less than vs 25.0 months, hazard ratio HR=0.54, P<0.0001), and a higher proportion of patients achieved rPFS at 24 months (70.3% vs 52.1%). In addition, progression to metastatic castration-resistant prostate cancer (mCRPC) was significantly delayed in the darotamine group (vs 13.8 months, HR=0.40). In terms of overall survival (OS), a similar proportion of patients reached 24 months in the darotamine and placebo groups (79.8% vs 75.5%).

Darotamine, an oral androgen receptor inhibitor, was first approved for marketing in July 2019. To date, darotamine has been approved for two indications, including ① as a monotherapy in adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and ② in combination with docetaxel in adult patients with mHSPC.