Elacestrant (ORSERDU) is being evaluated in combination with everolimus or abemaciclib in ER+/HER2- locally advanced or metastatic breast cancer, with updated Phase 2 ELEVATE trial data showing progression-free survival benefits across multiple patient subgroups.

The presenting expert, Virginia Kaklamani, and Menarini CEO Elcin Barker Ergun, emphasize that safety profiles of the combinations align with those of the individual drugs, with no new safety signals identified.

Key safety takeaways include no new safety signals for elacestrant in combination with either everolimus or abemaciclib; safety profiles remain consistent with prior studies.

Menarini Group and Stemline Therapeutics are leading the development and presenting SABCS data from December 9–12, 2025.

Data presented at SABCS detail two Phase 2 combination studies, with supportive safety profiles aligned to the known characteristics of each drug in combination with standard endocrine therapy.

Background on ORSERDU (elacestrant) labeling covers safety information, adverse reactions, cautions (lipid changes, embryo-fetal toxicity, CYP3A4 interactions), and reporting channels and company information.

About the companies: Menarini Group and Stemline Therapeutics are collaborating to develop elacestrant, with Stemline marketing other oncology drugs and Menarini maintaining a broad international presence.

Key researchers and executives quoted emphasize elacestrant’s potential as an endocrine backbone in combination settings and note safety signals are consistent with each drug’s established profiles.

Additional SABCS presentations highlight broader elacestrant research, including SOLTI-2104-Premiére, ELEGANT (phase 3), ADELA (phase 3), ERADICATE, HELP trials, and various investigator-initiated and collaboration studies.

Menarini Group and Stemline Therapeutics are coordinating the press release, with media contacts provided for follow-up.

Safety information highlights potential dyslipidemia risks (hypercholesterolemia and hypertriglyceridemia), embryo-fetal toxicity, and common adverse reactions; drug interactions focus on CYP3A4 inhibitors/inducers, with guidance for pregnancy, hepatic impairment, and lactation.

Safety profiles of the combinations align with the known safety profiles of the individual agents, with no new safety signals reported.

Results show a consistent PFS benefit for the combinations regardless of ESR1 mutation status, with safety profiles aligned to the known profiles of each component therapy plus standard endocrine therapy.

Supporting references include real-world data publications and Clin Cancer Res articles highlighting elacestrant outcomes and genomic factors in ESR1-mutant metastatic breast cancer.