FDA Approval Insights: Darolutamide Plus Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Jacob Berchuck, MD, a physician at Dana-Farber Cancer Institute and an instructor in medicine at Harvard Medical School, to discuss the FDA approval of darolutamide (Nubeqa) plus docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC).

The regulatory decision, announced on August 5, 2022, was based on findings from the phase 3 ARASENS trial (NCT02799602), in which darolutamide plus docetaxel improved median overall survival (OS) vs docetaxel alone. The median OS with darolutamide/docetaxel was not reached (95% CI, NR-NR) vs 48.9 months (95% CI, 44.4-NR) with docetaxel alone (HR 0.68; 95% CI, 0.57-0.80; P <.0001).

Additionally, treatment with darolutamide plus docetaxel led to a significant delay in time-to-pain progression (HR 0.79; 95% CI, 0.66-0.95; 1-sided P =.006).

In our exclusive interview, Dr Berchuck discussed the effects of treatment intensification with darolutamide in men with mHSPC, the significance of the approval of darolutamide plus docetaxel and androgen deprivation therapy, and lingering questions left unanswered by the pivotal ARASENS study.

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