FLORENCE, Italy and NEW YORK, December 8, 2025 — The Menarini Group and its oncology subsidiary Stemline Therapeutics unveiled new Phase 2 ELEVATE study combination data for elacestrant (ORSERDU®) in patients with estrogen receptor–positive (ER+), HER2-negative metastatic breast cancer (mBC) at the 2025 San Antonio Breast Cancer Symposium (SABCS). The updated results show meaningful and consistent median progression-free survival (mPFS) benefits across combination regimens with everolimus and abemaciclib, reinforcing elacestrant’s growing potential as a backbone endocrine therapy in both metastatic and earlier-stage breast cancer settings.
Science Significance
The new ELEVATE dataset expands the scientific evidence supporting elacestrant as a next-generation oral selective estrogen receptor degrader (SERD) capable of overcoming diverse endocrine-resistance mechanisms. The Phase 2 results demonstrated mPFS of 8.3 months with everolimus and 14.3 months with abemaciclib, with benefits observed irrespective of ESR1 mutation status, a finding that underscores the drug’s broad biological applicability. These results extend the mechanistic insights first revealed in the pivotal EMERALD study and offer deeper scientific rationale for oral-oral combinations designed to delay resistance evolution, maximize receptor targeting, and improve tumor control in ER+/HER2- mBC.
Regulatory Significance
The consistency of the new ELEVATE data enriches the growing body of clinical evidence that may support future regulatory submissions for expanded use of elacestrant in combination regimens. With multiple ongoing global studies—including Phase 3 trials such as ADELA and ELEGANT—the updated efficacy and safety findings align with regulatory trends encouraging the development of precision-targeted endocrine therapies. The absence of new safety signals and the favorable tolerability profile observed in the combinations strengthen the foundation for elacestrant’s possible trajectory toward broader label expansions, particularly in treatment settings where resistance to endocrine therapy and CDK4/6 inhibitors remains a major challenge.
Business Significance
Advertisement
The latest results reinforce Menarini’s strategic position in the competitive hormone-receptor–positive breast cancer market, one of the largest oncology segments globally. By demonstrating robust performance across multiple combinations, elacestrant continues to strengthen its commercial potential as a versatile therapeutic platform rather than a single-use monotherapy. The findings also highlight the value of the company’s diversified development program, which spans metastatic, early-stage, and combination-focused clinical pathways. Strong clinical momentum may further enhance Menarini’s market reach, accelerate partnerships, and support the continued global commercialization of ORSERDU in regions where unmet need remains significant.
Patients’ Significance
For patients with ER+/HER2- metastatic breast cancer, especially those whose disease has progressed on endocrine therapy or after exposure to CDK4/6 inhibitors, the ELEVATE results bring renewed treatment optimism. The consistent PFS improvements across multiple disease subgroups—including those with visceral disease, ESR1 mutations, and PIK3CA mutations—reflect elacestrant’s potential to benefit diverse patient populations facing limited therapeutic options. Its oral administration, favorable tolerability, and emerging performance in combination regimens provide a patient-centered therapeutic approach aimed at prolonging disease control while preserving quality of life.
Policy Significance
The expanding clinical evidence for elacestrant may influence future oncology guideline updates, particularly in treatment algorithms for endocrine-resistant ER+/HER2- mBC. As real-world data and global clinical trial results continue to validate elacestrant’s therapeutic role, policymakers and health-technology assessors may increasingly consider its incorporation into reimbursement pathways, precision-oncology treatment frameworks, and value-based care models. The evolution of endocrine therapy strategies underscores a broader policy shift toward supporting innovative oral targeted therapies that combine effectiveness, accessibility, and manageable safety for large patient populations.
The robust Phase 2 ELEVATE combination data presented at SABCS further strengthens elacestrant’s position as a leading next-generation endocrine therapy for ER+/HER2- metastatic breast cancer. With its expanding global development program, consistent PFS improvements, and favorable safety across combination regimens, elacestrant stands out as a promising therapeutic anchor for overcoming endocrine resistance. As Menarini advances multiple Phase 2 and Phase 3 trials worldwide, the drug’s growing clinical momentum continues to shape the future landscape of precision endocrine oncology and offers patients renewed hope for extended disease control.
Source: Menarini Industrie Farmaceutiche Riunite press release
