Menarini Group Unveils Promising Elacestrant Data for Breast Cancer Treatment

Elacestrant Data Presented at SABCS 2025

The Menarini Group, a global leader in pharmaceuticals and diagnostics, recently revealed pivotal data focused on the use of Elacestrant (brand name ORSERDU®) in the treatment of patients suffering from estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC). This significant announcement was made during the highly anticipated San Antonio Breast Cancer Symposium (SABCS) held from December 9 to 12, 2025, showcasing updated results from their Phase 2 study named ELEVATE.

Understanding the ELEVATE Study

The ELEVATE study is designed to assess the safety and efficacy of Elacestrant when used in combination therapies, particularly against varying resistance mechanisms encountered in patients with ER+/HER2- mBC. The underlying objective is to explore how these combinations can potentially enhance treatment outcomes, signifying a substantial step forward in personalized cancer treatment strategies.

Research data presented highlights that Elacestrant, when combined with Everolimus or Abemaciclib, consistently shows progression-free survival (PFS) advantages. This holds true regardless of the ESR1 mutation status in patients who have experienced disease progression while on endocrine therapy.

Virginia Kaklamani, a prominent figure in oncology and professor at UT Health San Antonio, commented, "The encouraging data regarding progression-free survival strengthens our confidence in the role Elacestrant could play in combination endocrine therapy." This statement underpins the belief that Elacestrant could significantly improve treatment efficiency in resistant types of breast cancer.

Key Findings from the Trial

The updated results of the ELEVATE study, as analyzed during the symposium, reported the median progression-free survival (mPFS) across multiple patient subgroups receiving two specific combination regimens. Here’s a snapshot of the findings:

- Elacestrant + Everolimus:

- Overall mPFS: 8.3 months (95% CI: 4.0 – 10.2)
- Patients with visceral disease: 7.7 months (95% CI: 3.8 – 9.4)
- Patients without prior Fulvestrant: 8.3 months (95% CI: 4.2 – 12.9)

- Elacestrant + Abemaciclib:

- Overall mPFS: 14.3 months (95% CI: 7.3 – 16.6)
- Patients with visceral disease: 14.3 months (95% CI: 7.4-16.6)
- Patients without primary endocrine resistance: 14.3 months (95% CI: 7.3-16.6)

These results strongly indicate that Elacestrant, particularly when combined with well-established agents like Everolimus and Abemaciclib, maintains a favorable safety profile while demonstrating enhanced efficacy in managing advanced forms of breast cancer.

Future Directions and Ongoing Research

As part of its commitment to clinical research and patient outcomes, the Menarini Group plans to continue exploring the usefulness of Elacestrant in various ongoing studies targeting both early-stage and metastatic breast cancer cases. CEO Elcin Barker Ergun emphasized, “Our evidence base for Elacestrant expands onto recent practice data supporting its unique role within the cancer treatment continuum.”

In addition to the presentations regarding Elacestrant’s performance, multiple supporting studies and updates will be shared at the symposium, aiming to build a comprehensive profile for this promising therapy.

Conclusion

Elacestrant represents a noteworthy advancement in the treatment landscape of ER+/HER2- metastatic breast cancer, effectively addressing persistent challenges posed by treatment resistance and diversifying the available therapeutic strategies. With ongoing trials and promising data, the Menarini Group continues to pave the way in oncology, striving to improve patient outcomes and transform the battle against breast cancer.

For healthcare professionals and patients alike, the developments surrounding Elacestrant are hopeful signs of progress in a demanding field, offering new strategies to combat one of the most challenging cancers.