Menarini Group Unveils Promising Phase 2 Elacestrant Data at San Antonio Breast Cancer Symposium
Menarini Group Unveils Promising Phase 2 Elacestrant Data at San Antonio Breast Cancer Symposium
The Menarini Group, a leading international pharmaceutical and diagnostic company, along with its subsidiary Stemline Therapeutics, recently presented crucial findings from a Phase 2 clinical study examining Elacestrant (ORSERDU®), aimed at treating patients with metastatic breast cancer (mBC) that is ER-positive and HER2-negative. The presentation took place at the 2025 San Antonio Breast Cancer Symposium (SABCS), attracting significant attention from medical professionals and stakeholders in the oncology sector.
Overview of the Phase 2 Study
This pivotal study, known as ELEVATE, evaluated the effectiveness and safety of two combination therapy regimens involving Elacestrant. The goal was to address various mechanisms of resistance often encountered in ER+/HER2- breast cancer and improve outcomes for patients suffering from locally advanced or metastatic forms of the disease. Updated results showcased an encouraging median progression-free survival (mPFS) for both regimens tested, which has raised hopes for new treatment protocols in advanced breast cancer.
Virginia Kaklamani, MD, DSc, a notable figure in the field and a professor at UT Health San Antonio, emphasized the significance of the data showcased at SABCS. "The promising progression-free survival data bolster our confidence in Elacestrant's potential as a backbone endocrine therapy in combination treatments," she stated. Kaklamani added that the safety profile of Elacestrant combined with Everolimus or Abemaciclib aligns with previously established safety records, marking no new safety signals.
Key Findings from ELEVATE
The findings presented during the symposium revealed that Elacestrant, when paired with either Everolimus or Abemaciclib, leads to consistent improvements in progression-free survival rates. Notably, the advantages observed remained apparent regardless of the presence of ESR1 mutations, particularly for patients whose disease progressed under endocrine therapy, with prior exposure to CDK4/6 inhibitors either way.
Detailed mPFS Results
The updated findings from the ELEVATE trial provide robust data:
- - For Elacestrant 345 mg QD + Everolimus 7,5 mg QD (n=50): mPFS was found to be 8.3 months (with a 95% confidence interval of 4.0 – 10.2).
- - For Elacestrant 345 mg QD + Abemaciclib 150 mg BID (n=60): mPFS showed significant improvement to 14.3 months (with a 95% CI of 7.3-16.6).
These results underline the potential of Elacestrant within treatment combinations targeting breast cancer, a disease characterized by high heterogeneity and a challenging therapeutic landscape.
Future Directions and Ongoing Trials
Menarini's commitment to exploring Elacestrant's full range of benefits continues, with various ongoing clinical trials targeting both early-stage and metastatic breast cancer. Elcin Barker Ergun, CEO of Menarini Group, reaffirmed the corporation's dedication to innovative cancer treatments, saying, "The substantial evidence supporting Elacestrant, including real-world data from our pivotal EMERALD trial, highlights its evolving role in combination therapies."
At the SABCS, additional updates related to Elacestrant were presented across several sessions, aiming to explore its application throughout the spectrum of breast cancer cases. Notable presentations included:
- - The role of Elacestrant combined with Triptorelin in premenopausal women with early stage ER+/HER2 disease.
- - An assessment of Elacestrant monotherapy and its efficacy compared to standard endocrine therapy among high-risk early-stage breast cancer patients.
Conclusion
As the SABCS progresses, enthusiasm surrounding Elacestrant is palpable, with many in the oncology community hopeful that its potential will lead to more effective treatment regimens for one of the most common cancers affecting women worldwide. The Menarini Group remains focused on advancing research initiatives involving Elacestrant, further solidifying its pivotal role in the ongoing fight against breast cancer. The details shared at the symposium mark a critical point in both clinical research and patient outcomes, shaping the future of breast cancer treatment strategies.
For detailed information regarding Elacestrant, visit ORSERDU's official page.
Topics Health）
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