François-Clément Bidard, MD PhD, professor, medicine, Department of Medical Oncology, Institut Curie & UVSQ/Université Paris-Saclay; co-coordinator, Breast Cancer Research, Institut Curie, discusses the significance of the FDA approval of elacestrant (Orserdu) in patients with estrogen receptor (ER)–positive, HER2-negative metastatic breast cancer and key efficacy and safety data from the phase 3 EMERALD trial (NCT03778931).

On January 27, 2023, the FDA approved elacestrant in postmenopausal women or adult men with ER-positive, HER2-negative, 

-mutated advanced or metastatic breast cancer who have progressed on at least 1 line of endocrine therapy. The approval was based on the results of the EMERALD trial, which enrolled patients with ER-positive, HER2-negative disease who had failed 1 or 2 prior lines of endocrine therapy, including a mandatory CDK4/6 inhibitor and up to 1 prior line of chemotherapy in the advanced or metastatic setting. In total, 47.8% of patients in EMERALD had 

Dr. Bidard on the Efficacy of Elacestrant in HR+/HER2– Breast Cancer

This approval provides a new therapeutic option for patients in the ER-positive, HER2-negative, 

-mutated metastatic breast cancer population, which previously had an unmet need for effective treatment, Bidard says. Additionally, this is the first FDA approval for an oral selective estrogen receptor degrader (SERD) in breast cancer, Bidard emphasizes. Many other oral SERDs for breast cancer are in development, and the approval of elacestrant supports continued research with this class of drugs, Bidard says.

In EMERALD, treatment with elacestrant led to a median progression-free survival of 3.8 months vs 1.9 months with investigator’s choice of endocrine therapy in patients with 

 mutations, translating to a 45% reduction in the risk of disease progression or death. These findings demonstrate that patients who have previously received endocrine therapy now have the option to receive an effective agent that can further extend their survival, Bidard notes.

Dr. Bidard on the Safety Profile of Elacestrant

 reported that elacestrant was well tolerated, which was expected, as endocrine therapies typically have limited toxicities, Bidard says. The main toxicities observed were low-grade nausea, vomiting, fatigue, and decreased appetite, Bidard explains. Overall, elacestrant is a safe drug to offer to patients, Bidard concludes.

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.

Videos

François-Clément Bidard, MD PhD, discusses the significance of the FDA approval of elacestrant in patients with estrogen receptor–positive, HER2-negative metastatic breast cancer and key efficacy and safety data from the phase 3 EMERALD trial. 

Dr. Bidard on the FDA Approval of Elacestrant in ER+/HER2– Metastatic Breast Cancer

Francois-Clement Bidard, MD, PhD, a professor in the Department of Medical Oncology, and the head of the Translational Research Group at the Institut Curie, discusses the importance of elacestrant (RAD-1901) in estrogen receptor (ER)–positive, HER2-negative, advanced or metastatic breast cancer.

The phase 3 EMERALD trial (NCT03778931) compared the efficacy and safety of elacestrant with a standard-of-care regimen of fulvestrant (Faslodex) or an aromatase inhibitor in patients with ER-positive, HER2-negative breast cancer that had advanced on endocrine therapy. 

a new drug application has been submitted to the FDA seeking the approval of elacestrant

Elacestrant has performed better than other agents, which is a benefit for these patients, Bidard says. The agent must be used in the correct patient population to have the benefit translate to clinical practice, Bidard explains. Patients who could benefit include those who have not received any prior chemotherapy or those who harbor 

Other methods should also be explored to stratify patients and understand which patients could be safely treated with single-agent elacestrant, Bidard concludes.

Francois-Clement Bidard, MD, PhD, discusses the importance of elacestrant in estrogen receptor–positive, HER2-negative, advanced or metastatic breast cancer.


Dr. Bidard on the Importance of Elacestrant in ER+/HER2- Breast Cancer

Francois-Clement Bidard, MD, PhD, professor, medical oncologist, Institut Curie, discusses the clinical utility of circulating tumor cell count (CTC) in breast cancer at the 2018 San Antonio Breast Cancer Symposium.

CTC count was found to be a useful method of selecting frontline treatment for patients with estrogen receptor—positive, HER2-negative metastatic breast cancer. Data presented from the phase III STIC CTC trial revealed that CTC count can be used to guide treatment decisions in terms of hormone therapy and chemotherapy. In the trial, 778 patients were randomized 1:1 to a physician’s choice hormone therapy or chemotherapy arm or to a CTC-guided treatment arm.

The study met its primary endpoint of CTC-driven noninferiority. Patients whose treatment was adjusted to chemotherapy based on CTC count had a 5-month extension in median progression-free survival versus patients in the physician’s choice arm. Moreover, overall survival was 37.1 months compared with 42 months in the physician’s choice and CTC-driven arms, respectively.

Because the trial was conducted prior to the introduction of CDK4/6 inhibitors, it should only serve to guide treatment decisions between frontline hormone therapy and chemotherapy. Nonetheless, this research suggests that CTC count can be used as a prognostic biomarker in this setting and may lead to improved survival.

Francois-Clement Bidard, MD, PhD

Articles

Dr. Bidard on the FDA Approval of Elacestrant in ER+/HER2– Metastatic Breast Cancer

Dr. Bidard on the Importance of Elacestrant in ER+/HER2- Breast Cancer

Dr. Bidard on the Clinical Utility of Circulating Tumor Cell Count in Breast Cancer