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Menarini Group Presents Updated Insights on Elacestrant at ASCO 2025

The Menarini Group, a leading international pharmaceutical and diagnostics company, along with Stemline Therapeutics, Inc., is set to showcase updated preliminary results concerning the effectiveness of Elacestrant (marketed as ORSERDU®) for patients suffering from estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (mBC) at the 2025 American Society of Clinical Oncology (ASCO) annual meeting. This presentation will highlight promising combinations with other targeted therapies, emphasizing Elacestrant's role in transforming the treatment landscape for mBC.

ELEVATE Study Highlights

The update will feature efficacy analyses derived from cohorts of the ELEVATE study, where Elacestrant is examined alongside various targeted agents including Everolimus and Ribociclib. The ELEVATE study, designed to assess the safety and effectiveness of oral combination treatments, aims to overcome resistance mechanisms present in ER+/HER2- mBC patients. Early results indicate encouraging progression-free survival (PFS) rates for combinations involving Elacestrant + Ribociclib as well as Elacestrant + Everolimus. The recommended phase 2 dose (RP2D) has been established at 345 mg of Elacestrant combined with 400 mg of Ribociclib and 345 mg of Elacestrant with 7.5 mg of Everolimus, which has previously been reported as effective.

Dr. Hope S. Rugo, from the City of Hope Comprehensive Cancer Center, expressed optimism about these findings, remarking on the encouraging preliminary results concerning both effectiveness and safety when combining Everolimus and Ribociclib with Elacestrant. These developments align with promising data previously shared from another cohort involving Elacestrant and Abemaciclib, which also demonstrated favorable outcomes.

Safety and Further Investigations

Additionally, new safety data will be presented, underscoring consistency with the established safety profiles of the respective targeted therapies paired with Elacestrant. Elcin Barker Ergun, CEO of Menarini Group, emphasized the potential of Elacestrant as a combination partner in the treatment of metastatic ER+/HER2- breast cancer. The company is also investigating other patient groups with ongoing studies like the ELEGANT study, which explores the benefits of Elacestrant for high-risk, early-stage breast cancer patients.

The combination therapies being researched within the ELEVATE framework consist of Elacestrant paired with CDK4/6 inhibitors (namely Palbociclib, Abemaciclib, and Ribociclib) as well as inhibitors targeting the PI3K/AKT/mTOR pathway (including Everolimus, Alpelisib, and Capivasertib). With the update at ASCO 2025 offering a glimpse into the future of breast cancer treatment, attendees can look forward to a comprehensive overview of how Elacestrant is positioned within oncological settings.

Additional Presentations at ASCO

Further details concerning the study's findings will be presented in abstracts and discussion sessions at ASCO 2025. Among notable presentations will be:

• - Elacestrant in Combination with Ribociclib and Everolimus in Patients with ER+/HER2- mBC – Abstract number 1070, scheduled for June 2nd, 2025.
• - Assessing the Safety of Elacestrant Combinations in ER+/HER2- mBC – Abstract number 1079, also scheduled for June 2nd, 2025.

With the ongoing challenges posed by ER+/HER2- mBC, the emergence of new combination therapies, including Elacestrant, promises to enhance treatment efficacy and improve patient outcomes.

Conclusion

As Menarini and Stemline continue their commitment to innovation in the oncology field, the insights shared at ASCO 2025 signify a critical advancement for effective management strategies in breast cancer care, potentially setting the stage for new standards in therapeutic practice for oncologists. For further details on Elacestrant and its promising applications, please visit Menarini's official website for comprehensive information and updates.