Virginia Kaklamani, MD - UT Health San Antonio discusses Elacestrant (ORSERDU), an oral endocrine therapy, has been approved by the FDA for the treatment of advanced or metastatic breast cancer with ESR1-mutations. These mutations are found in up to 40% of tumors in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. A previous analysis showed that patients with ESR1-mut tumors who had prior CDK4/6 inhibitor (CDK4/6i) exposure for at least 12 months experienced a median progression-free survival (PFS) of 8.6 months with elacestrant compared to 1.9 months with standard of care (SOC).
A new analysis of the EMERALD clinical study examined elacestrant's effectiveness in a subgroup of patients with Non-Detected ESR1-mut tumors whose disease progressed within six months of CDK4/6i therapy. The results demonstrated a median PFS of 5.32 months with elacestrant compared to 1.87 months with SOC for these patients.
The Menarini Group and Stemline Therapeutics announced the results of this analysis, which will be presented at the ASCO Annual Meeting. The EMERALD Phase 3 trial, which evaluated elacestrant as second- or third-line monotherapy, demonstrated statistically significant PFS compared to SOC endocrine monotherapy.
The safety data were consistent with previous reports, with most adverse events being grade 1 and 2. The discontinuation rates due to treatment-related adverse events were low. The new data suggest that elacestrant may provide clinical benefit to patients with Non-Detected ESR1-mut tumors who progressed within six months of CDK4/6i treatment.
Menarini Group aims to develop innovative solutions to address unmet needs in cancer treatments and sees elacestrant as an important step in providing oral endocrine therapy for advanced or metastatic ER+/HER2- tumors with ESR1 mutations.
The abstract for the ASCO presentation provides detailed information about the study design, subgroup analysis, and the session in which the results will be presented.
ORSERDU (elacestrant) has been approved by the FDA and is being further studied in clinical trials for metastatic breast cancer, both as monotherapy and in combination with other treatments. The Menarini Group holds global licensing rights for elacestrant and is responsible for its registration, commercialization, and ongoing development activities.