Menarini Group Shares Encouraging Phase 2 Data on Elacestrant Combination Regimens
The Menarini Group has presented new Phase 2 clinical findings evaluating elacestrant in combination with other targeted therapies for estrogen receptor-positive (ER+), HER2-negative metastatic breast cancer (mBC). While the results are encouraging, it is important to note that these data remain exploratory and are part of an ongoing effort to determine whether elacestrant may play a meaningful role in combination regimens for this patient population.
Progress to Date in Elacestrant’s Clinical Development
Updated results from the Phase 2 ELEVATE study highlight the potential of elacestrant when used alongside everolimus or abemaciclib. These oral-oral regimens are being investigated to better understand whether combination approaches can help address resistance mechanisms commonly seen in ER+/HER2- metastatic breast cancer. Because the study is still in Phase 2, the combinations’ effectiveness has not yet been confirmed and remains under evaluation.
Insights from the ELEVATE Study
According to Virginia Kaklamani, MD, DSc, the updated progression-free survival (PFS) data support the possibility that elacestrant could serve as an endocrine therapy backbone in the combination setting, pending results from further clinical investigation. Importantly, the safety observations reported so far align with the known profiles of elacestrant and the partner therapies, with no new safety signals identified.
Understanding the Phase 2 Findings
The ELEVATE data show that elacestrant in combination with everolimus or abemaciclib demonstrated a consistent PFS trend across key patient subgroups—regardless of ESR1 mutation status. These findings are preliminary but contribute to a growing body of evidence suggesting that combination regimens with elacestrant merit continued study.
Overview of Presented Data
The median PFS results shared at the 2025 San Antonio Breast Cancer Symposium (SABCS) cover a variety of patient subsets, including those with visceral disease, without prior fulvestrant exposure, or lacking primary endocrine resistance. For genomic subgroups in the elacestrant + abemaciclib cohort, PFS maturity has not yet been reached—further underscoring that these findings remain early.
Future Directions for Elacestrant Research
The Menarini Group continues to expand its clinical program for elacestrant across both metastatic and early breast cancer settings. Additional presentations at SABCS will explore elacestrant’s investigational use in several combination regimens and across varying disease stages and genetic contexts. These studies collectively aim to determine where elacestrant may provide added value when paired with other targeted therapies.
Perspective from Menarini Leadership
Elcin Barker Ergun, CEO of the Menarini Group, emphasized the company’s commitment to thoroughly investigating elacestrant across multiple trials. She noted that the evidence from both monotherapy and combination settings—though still developing—supports continued exploration of elacestrant’s potential benefit for patients.
Upcoming Scientific Presentations
Several investigator and company-sponsored presentations at SABCS will highlight elacestrant’s ongoing research program, including:
- Phase 2 combinations with everolimus or abemaciclib
- Evaluation in early-stage breast cancer in combination with triptorelin
- Studies assessing elacestrant alongside trastuzumab deruxtecan
- Trials exploring elacestrant in adaptive radiotherapy settings
- A Phase 3 randomized investigation of elacestrant + everolimus in ESR1-mutated advanced breast cancer
About the Menarini Group
As a global pharmaceutical and diagnostics company with a broad R&D footprint, the Menarini Group continues to focus on delivering innovative treatments in areas with significant unmet medical need. Their oncology pipeline—both commercialized products and investigational agents—reflects their long-term commitment to advancing patient care.
Frequently Asked Questions
What is the approved U.S. FDA indication for elacestrant (ORSERDU)?
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.
This is the only FDA-approved indication and should be used when referencing elacestrant’s current clinical use.
Are the new results definitive proof of effectiveness in combination regimens?
No. The findings are from Phase 2 research, meaning the combinations’ effectiveness remains under investigation. The results indicate potential clinical benefit, which must be confirmed through later-phase trials.
What did the ELEVATE study show?
The Phase 2 data suggest consistent trends in progression-free survival when elacestrant is combined with everolimus or abemaciclib. These trends were observed across multiple patient subgroups, though the results are not yet mature for certain genomic cohorts.
Is elacestrant safe when used with other therapies?
Based on the Phase 2 findings, the safety of the combinations appears consistent with the known profiles of the individual agents, and no new safety signals have been reported. However, because the research is ongoing, safety assessments will continue in later phases.
Why is elacestrant being studied in so many different settings?
Researchers aim to determine the full potential of elacestrant across treatment contexts—from metastatic disease to early breast cancer—and in combination with a variety of targeted therapies. Each study helps clarify which patients may benefit most and in what treatment settings
