Menarini Group Shares Updated Phase 2 Combination Data for Elacestrant
The Menarini Group has presented new Phase 2 clinical data evaluating elacestrant, an oral endocrine therapy, in combination regimens for estrogen receptor-positive (ER+), HER2-negative metastatic breast cancer (mBC). While these findings are encouraging, they remain investigational and are part of an ongoing effort to understand elacestrant’s potential role within combination treatment strategies.
Early-Phase Findings in Combination Settings
During a recent oncology symposium, researchers shared updated results from the Phase 2 ELEVATE study, which is exploring whether elacestrant, when combined with targeted agents such as everolimus or abemaciclib, may help address treatment resistance in ER+/HER2- mBC. The findings indicate preliminary trends in median progression-free survival (mPFS), but effectiveness of these combinations has not been established, and further research is required.
Virginia Kaklamani, MD, DSc, noted that the progression-free survival signals observed to date support continued investigation into elacestrant as a potential endocrine therapy backbone in combination regimens. Importantly, the safety data so far align with the expected profiles of the individual therapies, with no new safety signals reported.
Understanding the Phase 2 Progression-Free Survival Trends
Phase 2 results suggest consistent PFS trends across patient subgroups receiving elacestrant with either everolimus or abemaciclib. These signals were observed even in patients who progressed on prior endocrine therapy—though the results remain exploratory and are not conclusive.
ESR1 Mutation Status and Treatment Response
The study also examined outcomes based on ESR1 mutation status, with early indications suggesting that the potential benefit of these investigational combinations may extend across mutation subtypes. However, these findings require confirmation in larger, later-phase trials before informing treatment decisions.
Continued Commitment to Research
Elcin Barker Ergun, CEO of the Menarini Group, reiterated the company’s commitment to fully investigating elacestrant through multiple ongoing clinical trials. These studies aim to better understand elacestrant’s potential across early and metastatic breast cancer settings and in a range of combination approaches.
Upcoming Presentations
Additional elacestrant-related presentations planned for upcoming oncology meetings will further examine its investigational use:
- In combination with novel targeted therapies
- In early breast cancer settings
- Across various genetic and clinical subgroups
These efforts reflect Menarini’s broader strategy to better understand where elacestrant may provide value as part of evolving treatment paradigms.
About the Menarini Group and Elacestrant
The Menarini Group is an international pharmaceutical company dedicated to developing innovative solutions for diseases with significant unmet need. Elacestrant is a key part of its oncology portfolio and is being extensively studied in both company-sponsored and investigator-initiated trials across a spectrum of breast cancer studies.
Frequently Asked Questions
What is the FDA-approved 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 approved indication and should be used when referencing elacestrant’s current clinical status.
Are the combination results definitive?
No. The ELEVATE study is Phase 2, meaning all combination findings are preliminary and require confirmation in later-phase trials.
What did the Phase 2 findings show?
They showed encouraging trends in progression-free survival when elacestrant was combined with everolimus or abemaciclib, with safety results consistent with known profiles. These findings indicate potential benefit but are not conclusive.
What are some known adverse reactions to elacestrant?
Reported side effects include musculoskeletal pain, nausea, and metabolic changes, among others. Full safety information is available in the prescribing information for ORSERDU.
When will more data be available?
Additional analyses will be presented at upcoming oncology conferences as Menarini continues to evaluate elacestrant in a range of investigational combination and monotherapy settings.
