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Menarini Group Presents Key Elacestrant Findings at ASCO 2025

On May 23, 2025, Menarini Group and its subsidiary Stemline Therapeutics shared updated insights on Elacestrant (ORSERDU®) during the American Society of Clinical Oncology (ASCO) Annual Meeting. This data emphasizes the potential of Elacestrant as a cornerstone therapy in combination with targeted agents for patients suffering from metastatic breast cancer (mBC) that is estrogen receptor-positive (ER+) and HER2-negative (HER2-).

The focus of the presentation revolved around the preliminary efficacy analysis of Elacestrant combined with other agents such as everolimus and ribociclib from the ELEVATE study. This analysis revealed updated safety data from various combination cohorts, providing strong evidence for Elacestrant’s role in enhancing treatment strategies for ER+/HER2- mBC.

Key Findings from ELEVATE Study

The ELEVATE study, designed to assess the effectiveness of Elacestrant in conjunction with various oral therapies, includes six treatment regimens. Each regimen evaluates the combination of Elacestrant with CDK4/6 inhibitors (palbociclib, abemaciclib, ribociclib) and PI3K/AKT/mTOR pathway inhibitors (everolimus, alpelisib, capivasertib). New data presented at ASCO 2025 demonstrated a preliminary favorable progression-free survival (PFS) in cohorts receiving Elacestrant with ribociclib and Elacestrant with everolimus. The recommended phase 2 doses were confirmed at 345 mg of Elacestrant combined with 400 mg of ribociclib and 7.5 mg of everolimus.

Dr. Hope S. Rugo, Director of the Women's Cancers Program at the City of Hope Comprehensive Cancer Center, expressed optimism in the results: "It is encouraging to see positive preliminary efficacy and safety outcomes from combining everolimus and ribociclib with Elacestrant. These findings align with previous promising data from the Elacestrant and abemaciclib cohort, indicating the potential of Elacestrant as a foundational endocrine treatment for metastatic breast cancer."

Additional Safety Updates

Further presented data focused on the safety outcomes from the same ELEVATE study, detailing four cohorts combining Elacestrant with ribociclib, everolimus, alpelisib, and capivasertib. These findings reiterated that the safety profiles of these combinations remain consistent with previously known outcomes associated with each targeted therapy coupled with standard endocrine treatment.

Elcin Barker Ergun, CEO of Menarini Group, highlighted the evolving significance of Elacestrant: "These results continue to affirm the potential value of Elacestrant as a combination therapy within the ER+/HER2- mBC treatment landscape. Moreover, we’re investigating its potential in early-stage breast cancer populations through our ongoing ELEGANT study, aimed at assessing benefits for high-risk recurrence patients."

Looking Ahead at ASCO 2025

Menarini will also present additional findings at ASCO, reinforcing their commitment to advancing research in this field. Among the presentations, key abstracts will cover:

• - Elacestrant (Ela) combinations with ribociclib (Ribo) and everolimus (Eve) in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC) (Abstract 1070)
• - Safety update from ELEVATE study (Abstract 1079)
• - ADELA Trial: a double-blind, randomized phase 3 trial on Elacestrant in ER+/HER2- advanced breast cancer (Abstract TPS1129)
• - ELCIN Study: evaluating Elacestrant in treatment-naïve ER+ mBC (Abstract TPS1127)
• - ELEGANT Trial: comparing Elacestrant with standard endocrine therapy in early breast cancer (Abstract TPS619)
• - EORTC-2129-BCG: evaluating Elacestrant for treating relapsed ER+/HER2- breast cancer patients (Abstract TPS620)

Conclusion

As global attention focuses on breast cancer treatment advancements, Menarini Group’s robust clinical development program for Elacestrant aims to address significant unmet needs in oncology. With promising early data and ongoing studies, Elacestrant is poised to make a substantial impact on the management of breast cancer, particularly among challenging populations. For more detailed information on the ongoing studies and results, visit Menarini Group’s website.