#USA #New York #Breast Cancer #Elacestrant #Menarini Group

Elacestrant Clinical Development Update at the 2025 SABCS

The Menarini Group, a prominent international pharmaceutical company, along with its subsidiary Stemline Therapeutics, is set to share compelling evidence from its Phase 2 ELEVATE study. This presentation, focusing on the use of Elacestrant (ORSERDU®) in combination therapies, aims to address unmet needs in estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC) at the upcoming San Antonio Breast Cancer Symposium (SABCS) scheduled for December 9-12, 2025.

Elacestrant has been making waves in cancer treatment since its initial launch. The efficacy seen in this ongoing clinical development program illustrates its potential as a crucial component of endocrine therapy. The latest data highlights some promising metrics related to median progression-free survival (mPFS).

Key Findings from the ELEVATE Study

The ELEVATE study examined the effectiveness of oral therapies aimed at overcoming resistance mechanisms typically observed in patients with ER+/HER2- mBC. The results underscore how the combination of Elacestrant with Everolimus or Abemaciclib can enhance patient outcomes. Virginia Kaklamani, MD, from UT Health San Antonio, noted, “The encouraging progression-free survival data increase our confidence in the role elacestrant could play as an endocrine therapy backbone in the combination setting.” The safety profile of Elacestrant when combined with these targeted therapies appears consistent with their previously known profiles, presenting no new safety signals among participants.

Presenting its comprehensive data, the ELEVATE study revealed the following mPFS results:

• - All patients: Elacestrant + Everolimus showed mPFS of 8.3 months, while Elacestrant + Abemaciclib reached 14.3 months.
• - Visceral disease: Both combinations exhibited similar results with Everolimus at 7.7 months and Abemaciclib maintaining 14.3 months.
• - With no prior fulvestrant: The performance remained steady with 8.3 months for Everolimus and 14.8 months for Abemaciclib.

Interestingly, these mPFS results persisted regardless of ESR1 mutation status in patients showing disease progression on endocrine therapy, even with or without earlier exposures to CDK4/6 inhibitors.

Upcoming Presentations Related to Elacestrant

The presentation slated for December 11 includes updates on Elacestrant’s application in combination with other treatments for various breast cancer stages. One such study examines the integration of Elacestrant with triptorelin in premenopausal women, while another focuses on Elacestrant against standard endocrine therapy for high-risk early breast cancer patients.

Moreover, the ADELA study will also be highlighted, which deals with advanced breast cancer patients with ESR1 mutations. The ongoing commitment to further explore Elacestrant underscores Menarini’s dedication to innovating treatments in the oncology landscape.

Future of Elacestrant

Menarini Group’s focus on Elacestrant continues in light of its pivotal role in addressing both advanced and earlier stage breast cancers. Their extensive clinical trial portfolio not only supports the development of combination therapies but also positions Elacestrant as a significant contender in the world of oncology.

Elcin Barker Ergun, CEO of Menarini Group, stated, “The evidence for elacestrant spans the monotherapy setting backed by real-world data, reinforcing its growing potential in combination regimens.” This commitment signals a promising future for patients afflicted by this devastating disease.

In conclusion, as the world waits for the extensive data release, the expectations surrounding Elacestrant at SABCS are high. Its implications could very well transform treatment protocols for patients suffering from ER+/HER2- metastatic breast cancer, providing new hope where options have been limited. With ongoing trials and enhanced insights, Elacestrant could redefine standards in cancer therapy.