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Menarini Group's New Findings on ORSERDU® at SABCS 2024

Menarini Group, a premier international pharmaceutical and diagnostics company, alongside its subsidiary Stemline Therapeutics, shared compelling new data on ORSERDU® (elacestrant) at the 2024 San Antonio Breast Cancer Symposium (SABCS). This annual meeting, scheduled from December 10 to 13, 2024, focuses on the latest advancements in breast cancer treatment.

Highlights from the Symposium

During this esteemed event, Menarini will present real-world data demonstrating the effectiveness of ORSERDU in patients diagnosed with advanced or metastatic breast cancer, specifically those who are ER+/HER2- and have the ESR1 mutation. This research is crucial as it underscores the role of ORSERDU as the first and only oral selective estrogen receptor degrader (SERD) approved in the United States for this patient population.

Since its FDA approval in January 2023, ORSERDU has become a beacon of hope for those with limited options after prior hormone therapy. Results indicate a median progression-free survival (PFS) of 6.8 months in the overall population and 8.0 months for patients who have undergone one to two lines of prior hormone therapy. These findings are indicative of a robust response across different subgroups.

Efficacy of Combination Therapy

Menarini will also present updated results from the ELECTRA and ELEVATE studies, which assessed the safety and efficacy of elacestrant in combination with abemaciclib. The results reveal a median PFS of 8.6 months across evaluable patients. Notably, those with the ESR1 mutation experienced a PFS of 8.7 months, while those without had a PFS of 7.2 months. This underscores the potential of elacestrant as a foundational therapy in combination regimens for advanced breast cancer.

Dr. Virginia Kaklamani of UT Health San Antonio remarked that these promising results highlight the necessity of testing for the ESR1 mutation at each disease progression, thus allowing tailored treatment approaches to optimize patient care. Such precision medicine strategies may significantly enhance outcomes for this vulnerable population.

Safety Profile of ORSERDU

The combined safety analysis from the ELECTRA and ELEVATE trials indicated a manageably predictable safety profile, with common adverse effects including diarrhea, nausea, and fatigue, aligning with established safety profiles for each drug component. There were no grade 4 adverse effects noted, which is encouraging for physicians and patients alike.

Dr. Hope S. Rugo of UCSF expressed optimism regarding the sustained PFS results from the combination therapy, affirming elacestrant's evolving role in the treatment landscape of ER+/HER2- advanced breast cancer.

Menarini's commitment to advancing clinical research remains steadfast, as they aim to harness the full potential of ORSERDU, both as monotherapy and in conjunction with other treatments. Elcin Barker Ergun, CEO of Menarini Group, emphasized the significance of these findings, stating they reflect a meaningful benefit that oncologists can deliver to their patients through ORSERDU.

Ongoing Clinical Trials and Future Directions

In addition to presenting new insights, Menarini Stemline will also share data from the phase 3 EMERALD trial and ongoing studies assessing elacestrant's roles in various treatment contexts. These trials are setting the stage for a deeper exploration into how elacestrant can impact patient care, particularly for those who have seen limited results from existing therapies.

As the conversation around effective treatments for breast cancer continues to evolve, the data presented by Menarini is significant for clinicians, researchers, and patients alike. It reinforces the shifting landscape of cancer treatment towards more precise, effective strategies that aim to improve the quality of life—and survival—for patients dealing with this challenging illness.