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

Podcast

In Partnership With:

Dr Berchuck discusses the effects of treatment intensification with darolutamide in metastatic hormone-sensitive prostate cancer, the significance of the approval of darolutamide plus docetaxel and androgen deprivation therapy, and questions left unanswered by the pivotal ARASENS study.

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.

___

That’s all we have for today! Thank you for listening to this episode of OncLive On Air®. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field.

For more updates in oncology, be sure to visit www.OncLive.com and sign up for our e-newsletters.

OncLive® is also on social media. On Twitter, follow us at @OncLive and @OncLiveSOSS. On Facebook, like us at OncLive and OncLive State of the Science Summit and follow our OncLive page on LinkedIn.

If you liked today’s episode of OncLive On Air®, please consider subscribing to our podcast on Apple Podcasts, Spotify, Google Podcasts, Amazon Music, and many of your other favorite podcast platforms,* so you get a notification every time a new episode is posted. While you are there, please take a moment to rate us!

Thanks again for listening to OncLive On Air®.

*OncLive On Air® is available on: Apple Podcasts, Google Podcasts, Spotify, Amazon Music, Audacy, CastBox, Deezer, iHeart, JioSaavn, Listen Notes, Player FM, Podcast Addict, Podchaser, RadioPublic, and TuneIn.

Related Videos
Phillip J. Koo, MD
Haeseong Park, MD, MPH
Phillip J. Koo, MD
Pasi A. Jänne, MD, PhD, discusses an exploratory analysis from the FLAURA2 trial of osimertinib plus chemotherapy in treatment-naive, EGFR-mutant NSCLC.
Jennifer Brown, MD, PhD
Rebecca L. Porter, MD, PhD
Wenxin (Vincent) Xu, MD,
Gautam Jha, MD
Emmanuel Antonarakis, MD, and Gautam Jha, MD
Daniel Spratt, MD