#United States #San Antonio #Breast Cancer #Elacestrant #Menarini Group

Elacestrant Data Presented at the 2025 San Antonio Breast Cancer Symposium

On December 8, 2025, the Menarini Group, a prominent name in pharmaceuticals and diagnostics, in collaboration with its subsidiary, Stemline Therapeutics, unveiled significant findings from the Phase 2 ELEVATE study at the prestigious San Antonio Breast Cancer Symposium (SABCS). These findings focused on Elacestrant (ORSERDU®), a promising treatment for estrogen receptor-positive (ER+), HER2-negative metastatic breast cancer (mBC).

The ELEVATE study aims to assess the effectiveness of combination treatments involving Elacestrant to confront resistance mechanisms that develop in patients with advanced forms of breast cancer. This innovative approach is crucial in enhancing patient outcomes, especially for those with ER+/HER2- mBC, who often face limited treatment options after endocrine therapy progression.

Dr. Virginia Kaklamani, a respected professor from UT Health San Antonio and a leader in breast cancer research, remarked, "The encouraging progression-free survival (PFS) data we have observed bolster our confidence in Elacestrant’s potential as a mainstay of endocrine therapy within combination treatments." She emphasized that the safety profile of Elacestrant, particularly when combined with other agents like everolimus or abemaciclib, aligns well with existing knowledge about these therapies, showing no newly identified safety concerns.

Study Results and Efficacy

The data presented at SABCS revealed compelling median progression-free survival (mPFS) results across different patient cohorts involved in the ELEVATE study. For those receiving Elacestrant paired with everolimus, the mPFS reached 8.3 months, while the combination with abemaciclib yielded an impressive 14.3 months. Further analysis showed consistent benefits regardless of the presence of ESR1 mutations, highlighting the versatility of Elacestrant in managing various types of ER+/HER2- mBC profiles.


These findings represent a significant advancement in the treatment landscape for patients who have exhausted endocrine therapies with or without CDK4/6 inhibitors.

Commitment to Ongoing Research

The Menarini Group’s commitment to exploring the capabilities of Elacestrant isn't just limited to the ongoing ELEVATE study. The trial design highlights various avenues of research that include combination therapies with multiple agents, indicating an active pursuit of optimizing treatment protocols for breast cancer. Elcin Barker Ergun, the CEO of the Menarini Group, articulated this vision, stating, "Our extensive evidence for Elacestrant, supported by both pivotal studies and real-world data, illustrates its growing promise in many combination scenarios."

At the symposium, additional ongoing studies related to Elacestrant were also unveiled. This includes trials exploring its role not just in mBC but across early breast cancer stages as well. Some notable presentations include data regarding Elacestrant in tandem with other agents like triptorelin, further reinforcing its multifaceted utility in oncology.

Conclusion

Elacestrant is rapidly establishing itself as a critical component in the arsenal against ER+/HER2- breast cancer. The findings shared at the 2025 SABCS highlight its potential benefits and safety profile, laying the groundwork for further exploration in clinical settings. Patients and practitioners alike may soon find hope in this emerging therapy's ability to enhance treatment outcomes in breast cancer care.

For more information on Elacestrant and its applications, including prescribing details, you can visit www.orserdu.com.