Menarini’s EMERALD study of ORSERDU in breast cancer shows promising results

The Menarini Group and its subsidiary, Stemline Therapeutics, Inc., have made a significant stride in breast cancer treatment with new findings from the pivotal EMERALD clinical study. These findings were recently presented at the 2023 San Antonio Breast Cancer Symposium (SABCS).

The post hoc analysis of the EMERALD study demonstrated a clinically meaningful improvement in progression-free survival (PFS) across various subgroups. This study evaluated the efficacy of single-agent ORSERDU (elacestrant) compared to standard-of-care treatments for patients with ER+, HER2- advanced or metastatic breast cancer (mBC), particularly those with ESR1 mutations and who had previously undergone treatment with CDK4/6 inhibitors for at least 12 months.

Dr. Virginia Kaklamani, a renowned breast medical oncologist, underscored the importance of these findings. She noted consistent improvements in PFS for patients treated with ORSERDU, including those with bone metastases, liver and/or lung metastases, and common co-mutations such as PIK3CA and TP53, as well as patients with HER2-low expression.

ORSERDU demonstrated significant improvements in PFS compared to standard-of-care endocrine monotherapies. The findings indicate that when ESR1 mutated tumors remain endocrine sensitive, the ER pathway could be a crucial driver of disease, irrespective of metastatic site or presence of concomitant mutations.

The EMERALD Phase 3 trial, a randomized, open-label, active-controlled study, evaluated elacestrant as a second- or third-line monotherapy in ER+, HER2- advanced/mBC patients. The trial enrolled 478 patients who had received prior treatment, including a CDK4/6 inhibitor. The primary endpoints were progression-free survival in the overall patient population and those with estrogen receptor 1 gene (ESR1) mutations.

ORSERDU (elacestrant) is indicated for postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

This development signifies a major advancement in breast cancer treatment, showcasing the Menarini Group’s commitment to providing innovative solutions to help improve the lives of people living with cancer. The data from the EMERALD study is expected to make a significant impact on the future of breast cancer therapy, particularly for those with ESR1 mutations.