FDA Approval Insights: Elacestrant in ER+/HER2– ESR1-mutated Advanced or Metastatic Breast Cancer

Podcast

Dr Bidard discusses the FDA approval of elacestrant in patients with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, key efficacy and safety data from the EMERALD trial, and the importance of testing for ESR1 mutations in patients with ER-positive, HER2-negative disease.

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, sponsored by Stemline Therapeutics, we had the pleasure of speaking with Francois-Clement Bidard, MD, PhD, about the FDA approval of elacestrant (Orserdu) in patients with estrogen receptor (ER)–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. Dr Bidard is a professor of medicine at the Institut Curie and Université Paris-Saclay, head of the translational research group for circulating cancer biomarkers, and cocoordinator of Breast Cancer Research at the Institut Curie in France.

On January 27, 2023, the FDA approved elacestrant in postmenopausal women or adult men with ER-positive, HER2-negative, advanced or metastatic breast cancer harboring an ESR1 mutation who have progressed on at least 1 line of endocrine therapy. The regulatory decision was based on findings from the phase 3 EMERALD trial (NCT03778931), in which patients who received elacestrant had a median progression-free survival of 3.8 months (95% CI, 2.2-7.3) vs 1.9 months (95% CI, 1.9-2.1) with control endocrine therapy.

In our exclusive interview, Dr Bidard discussed the significance of this approval, key efficacy and safety data from the EMERALD trial, and the importance of testing for ESR1 mutations in patients with ER-positive, HER2-negative disease.

___

That’s all we have for today! Thank you for listening to this episode of OncLive On Air®, sponsored by Stemline Therapeutics. 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.

Editor’s Note: Dr. Bidard has received research support from Pfizer, Prolynx, Menarini Silicon Biosystems, Merck KGaA, Rain Oncology, Roche, and Seagen; is a consultant for Astra-Zeneca, Caris, Daiichi-Sankyo, Exact Sciences, GE Healthcare, Gilead, GSK, Inatherys, Lilly, Menarini/Stemline, Novartis, Rain Oncology, Sanofi, and Seagen; is a speaker for Astra-Zeneca, Daiichi-Sankyo, Lilly, Menarini/Stemline, Pfizer, Rain Oncology, Sanofi, and Seagen; and is on the congresses for Astra-Zeneca, Pfizer, and Novartis.

Related Videos
A panel of 3 experts on breast cancer
A panel of 3 experts on breast cancer
Samilia Obeng-Gyasi, MD, MPH,
Nan Chen, MD
Timothy Yap, MBBS, PhD, FRCP
Parul N Barry, MD,
Erin Frances Cobain, MD
Erin Frances Cobain, MD
Video 6 - "Shared Decision Making and Multidisciplinary Collaboration in the Evolving HR+/HER2- Early-Stage Breast Cancer Landscape"
Manmeet Singh Ahluwalia, MD