Menarini Group Highlights Emerging Phase 2 Elacestrant Data at SABCS
The Menarini Group will present new Phase 2 research findings on elacestrant at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place December 9–12. These updates focus on patients with estrogen receptor-positive (ER+), HER2-negative metastatic breast cancer (mBC) and add to the growing body of early-stage evidence evaluating elacestrant’s potential in combination treatment approaches. As these results are still Phase 2, they should be interpreted as preliminary and exploratory.
Early Signals From Elacestrant’s Combination Studies
Recent investigational findings continue to support the possibility that elacestrant may play a future role in combination endocrine therapy regimens for ER+ mBC. In the ELEVATE Phase 2 study, elacestrant is being evaluated alongside targeted agents such as everolimus or abemaciclib. While these results are not definitive, the updated data suggest that the combinations may offer promising progression-free survival trends that warrant further clinical investigation.
Virginia Kaklamani, MD, DSc, noted that the PFS signals observed in Phase 2 heighten interest in elacestrant’s potential use as part of combination endocrine strategies—pending confirmation in later-phase trials.
Understanding the Phase 2 ELEVATE Findings
The ELEVATE trial is designed to explore whether combining oral therapies can help address resistance mechanisms seen in ER+/HER2- metastatic breast cancer. As a Phase 2 study, its insights help inform future research but do not establish effectiveness.
Consistent Trends Across Patient Subgroups
Early results indicate that elacestrant used with everolimus or abemaciclib shows potentially consistent PFS signals across multiple patient populations, including those with visceral disease and those harboring ESR1 mutations. Because the findings are preliminary—and in some genomic subgroups still not fully mature—additional research will be necessary to determine the true benefit of these combinations.
Safety Observations Remain Consistent
Across evaluated regimens, no unexpected safety findings have emerged in Phase 2 analyses. Safety profiles reported to date remain consistent with each partner therapy and with elacestrant's known safety characteristics.
Clinical Results in Context
Some Phase 2 cohorts, such as patients treated with elacestrant and abemaciclib, have shown encouraging median PFS signals (e.g., 14.3 months). However, because these findings come from a Phase 2 study without confirmatory comparative data, they serve as indicators of potential benefit—not validated clinical outcomes.
These data contribute to Menarini’s broader effort to assess elacestrant across various endocrine resistance settings and clinical stages.
Looking Ahead: Ongoing Trials and Future Analyses
Elcin Barker Ergun, CEO of the Menarini Group, reaffirmed the company’s commitment to advancing elacestrant research. Multiple ongoing studies continue to explore elacestrant in both metastatic and early breast cancer, including those evaluating its role in combination regimens, its activity in specific genetic subgroups, and its use in novel therapeutic approaches.
In addition to ELEVATE, several investigational studies will be featured at SABCS, reflecting the wide scope of scientific inquiry surrounding elacestrant.
Additional SABCS Presentations
Upcoming presentations will examine:
- Elacestrant in combination with other hormonal or targeted agents across diverse patient scenarios
- Elacestrant’s investigational use in early-stage disease, including studies combining it with agents such as triptorelin
- Combination studies with antibody-drug conjugates and other targeted therapies
These investigations continue to shape understanding of where elacestrant may offer benefit when paired with other treatments.
About the Menarini Group
The Menarini Group is a global pharmaceutical and diagnostics company focused on therapeutic areas with high unmet medical need, including oncology. With extensive R&D capabilities and international reach, Menarini aims to advance innovative cancer treatments and broaden access to effective therapies worldwide.
Frequently Asked Questions
What is elacestrant (ORSERDU)?
Elacestrant is an oral endocrine therapy. U.S. Indication: ORSERDU (elacestrant) 345 mg tablets is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Is elacestrant approved for use in combination therapy?
No. Combination use is investigational. The combinations highlighted in the ELEVATE study are Phase 2 exploratory regimens and are still under evaluation.
What are the early findings of elacestrant combination studies?
Phase 2 data suggest potential PFS benefits when elacestrant is combined with targeted therapies such as everolimus or abemaciclib. These findings require confirmation in larger, later-phase studies.
What safety information is available?
So far, combination regimens studied in Phase 2 have demonstrated safety profiles consistent with the known effects of each therapy, with no new safety signals identified. Patients should refer to full prescribing information for detailed safety guidance.
How is elacestrant being studied going forward?
Menarini is supporting multiple clinical trials evaluating elacestrant across metastatic and early breast cancer settings, including studies assessing combination strategies and potential activity in drug-resistant tumors.
