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Menarini and Stemline Therapeutics Unveil Phase 2 Findings of Elacestrant (ORSERDU®) in Metastatic Breast Cancer

Presenting Promising Efficacy at the San Antonio Breast Cancer Symposium 2025

In a significant development for oncology, Menarini Group, a renowned pharmaceutical and diagnostic leader, alongside its wholly-owned subsidiary Stemline Therapeutics, Inc., unveiled promising data concerning Elacestrant (ORSERDU®) at the San Antonio Breast Cancer Symposium 2025. The findings pertain to a Phase 2 clinical study focusing on patients diagnosed with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC).

The presentation, scheduled for December 11, 2025, highlights the efficacy of Elacestrant when combined with either Everolimus or Abemaciclib, targeting patients who have exhibited disease progression during endocrine therapy. This study, known as ELEVATE, was specially designed to evaluate the safety and effectiveness of these combined oral treatments to navigate the various resistance mechanisms observed in ER+/HER2- mBC.

Key Findings from the ELEVATE Study

The data presented reveal encouraging results relating to median progression-free survival (mPFS) in both treatment regimens. Specifically, patients receiving Elacestrant combined with:

• - Everolimus (7.5 mg) demonstrated an mPFS of 8.3 months (4.0 – 10.2).
• - Abemaciclib (150 mg) showed even more promising results, with an mPFS of 14.3 months (7.3 – 16.6).

These results emphasize Elacestrant’s potential as a leading endocrine therapy within combination settings, particularly highlighting the drug's ability to effectively manage therapeutic resistance among ER+/HER2- mBC patients.

Expert Commentary on the Data

Dr. Virginia Kaklamani, a prominent figure in the field and a professor at UT Health San Antonio, stated, "The encouraging data regarding progression-free survival strengthen our confidence in Elacestrant's role as a leading endocrine therapy in combination contexts." She further noted that the safety profile observed in these combinations aligns with known safety reports for each individual medication involved, indicating no new safety signals emerged during the study.

The results reveal that patients with ESR1 mutations showed consistent benefits from both combination therapies, highlighting Elacestrant’s effectiveness across a range of genetic backgrounds. Additionally, no substantial safety concerns have been identified, leading researchers to maintain optimism regarding the therapeutic potential of Elacestrant.

Future Directions for Elacestrant

Elacestrant continues to undergo scrutiny in several ongoing clinical trials designed to uncover its efficacy across multiple breast cancer contexts. Such trials include evaluations of Elacestrant’s effectiveness both as a standalone treatment and in conjunction with other innovative therapies in various patient populations.

Providing further insights into the symposium, other studies on Elacestrant will be showcased, examining its position in early breast cancer and combination therapies with other agents. The overarching goal remains to comprehensively explore Elacestrant’s benefits in different clinical scenarios.

Key abstracts to watch for at the symposium include:
1. Title: Elacestrant in combination with Everolimus or Abemaciclib in ER+/HER2- local advanced or metastatic breast cancer (mBC): Phase 2 results from ELEVATE.
- Presentation Date: December 11, 2025
- Presenter: Hope S. Rugo

2. Title: The ADELA study: A double-blind, placebo-controlled, randomized Phase 3 trial of Elacestrant (ELA) + Everolimus (EVE) in ER+/HER2- Advanced Breast Cancer Patients.
- Presentation Date: December 10, 2025
- Presenter: Antonio Llombart-Cussac

Conclusion

Menarini and Stemline stand firm in their commitment to advancing breast cancer treatment through continuous research and development. As the clinical landscape evolves, the anticipation surrounding Elacestrant and its applications in breast cancer treatment continues to grow. These recent findings showcase a significant leap towards improving outcomes for patients grappling with metastatic breast cancer, reaffirming the importance of dedicated innovation in cancer therapy.

For additional information regarding the safety profiles, indications, and complete prescribing information for ORSERDU, please visit ORSERDU.com.

About Menarini and Stemline Therapeutics

Menarini Group is an internationally leading pharmaceutical and diagnostics company, generating substantial revenues and employing a dedicated workforce. Stemline, its subsidiary, focuses on innovating treatments for patients battling cancer through advanced therapies such as Elacestrant.