#Italy #ORSERDU #Menarini #Elacestrant #Florence

New Data on ORSERDU® (Elacestrant) at the 2024 SABCS

The Menarini Group, in collaboration with Stemline Therapeutics, is set to reveal significant advancements at the upcoming 2024 San Antonio Breast Cancer Symposium (SABCS) from December 10 to 13. This year's presentation will focus on ORSERDU® (elacestrant), a groundbreaking oral medication for patients suffering from ER+, HER2- advanced or metastatic breast cancer (mBC).

The Significance of ORSERDU

ORSERDU is recognized as the first and only approved oral estrogen receptor antagonist (SERD) specifically targeting ESR1-mutated tumors, which are present in almost half of ER+/HER2- advanced breast cancer cases. Following its FDA approval in January 2023, significant developments in clinical application have emerged, particularly regarding its efficacy in real-world settings.

Real-World Data Highlights

Data to be showcased at the SABCS indicates that ORSERDU has achieved a median real-world progression-free survival (rwPFS) of 6.8 months across a broad patient demographic. More specifically, individuals with one to two lines of prior endocrine therapy (ET) reported an impressive median rwPFS of 8 months. Such results highlight the drug's potential effectiveness across various patient profiles, reinforcing its value in the treatment of breast cancer.

Virginia Kaklamani, MD, DSc, who serves as a breast medical oncologist, emphasized the importance of these findings: "These exciting data show clinically meaningful real-world progression-free survival with ORSERDU monotherapy. It underlines the urgency for clinicians to assess patients' tumors for ESR1 mutations at every progression point to better tailor treatments."

Combination Efficacy with Abemaciclib

In addition to the rwPFS data, Menarini will present updated results from studies evaluating ORSERDU in combination with other therapies, specifically abemaciclib. Preliminary findings from the ELECTRA study reveal encouraging progression-free survival results, with a median PFS of 8.6 months among patients receiving this combination therapy. Notably, those with ESR1 mutations displayed a slightly improved mPFS of 8.7 months compared to 7.2 months in patients without these mutations.

The safety profile of the combination treatment has been characterized as manageable, with common adverse events being consistent with the known effects of both elacestrant and abemaciclib. Reported side effects included nausea, diarrhea, and fatigue, but no new toxicity signals have emerged from ongoing trials, bolstering confidence in this treatment strategy.

Future Directions

As Menarini continues to build on these findings, Elcin Barker Ergun, CEO of Menarini, articulated a commitment to advancing clinical research on elacestrant, “We are dedicated to optimizing the utility of ORSERDU, enhancing its application in both monotherapy and combination regimens. These results illustrate its potential in benefiting oncologists and their patients significantly.”

Additionally, results from the Phase 3 EMERALD trial and other ongoing studies will be shared, marking an essential contribution to the broader field of oncology treatment strategies.

Conclusion

The upcoming presentation at the 2024 San Antonio Breast Cancer Symposium promises to enrich the dialogue surrounding treatment options for advanced breast cancer, underscoring ORSERDU's role in improving patient outcomes. With its innovative approach and real-world results, ORSERDU is positioned to be a vital component of the evolving landscape of breast cancer therapies.