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Menarini Group Showcases New Data on ORSERDU® at 2024 SABCS

The Menarini Group, in collaboration with Stemline Therapeutics, is set to present compelling new findings concerning ORSERDU® (elacestrant) at this year’s San Antonio Breast Cancer Symposium (SABCS), occurring from December 10-13, 2024. The spotlight is on ORSERDU's impact on treating patients with advanced or metastatic breast cancer (mBC) who test positive for estrogen receptor (ER) but negative for human epidermal growth factor receptor 2 (HER2). This presentation comes after significant progress since ORSERDU's FDA approval in January 2023.

Key Findings on ORSERDU®

Among the crucial data to be discussed are the results highlighting real-world progression-free survival (rwPFS) rates for adults diagnosed with ER+/HER2- mBC. Early analysis suggests a median rwPFS of approximately 6.8 months across the treated population, with those who had previously undergone one to two lines of endocrine therapy experiencing a notable median rwPFS of 8 months. These findings underscore the effectiveness of ORSERDU in real-world medical settings, reinforcing its therapeutic significance.

Dr. Virginia Kaklamani, a breast medical oncologist at UT Health San Antonio, expressed enthusiasm about these findings, stating, "These exciting data show clinically meaningful real-world progression-free survival with ORSERDU monotherapy. We need to ensure that tests for the ESR1 mutation are conducted frequently to tailor individualized treatment plans."

Results from Elacestrant and Abemaciclib Combination

the upcoming symposium will also delve into the new efficacy results from the combination treatment of elacestrant and abemaciclib. The findings from the ELECTRA phase 1b/2 study demonstrated a median progression-free survival of 8.6 months among all patients, with slightly better outcomes noted in patients harboring the ESR1 mutation.

These results reinforce the potential of combining elacestrant with established therapeutic agents such as abemaciclib, as indicated by Dr. Hope S. Rugo from the University of California, San Francisco, who remarked that these updates bolster the case for elacestrant becoming a cornerstone in metastatic breast cancer treatment regimens.

Advancing Clinical Research for Breast Cancer Patients

Menarini remains committed to expanding research efforts concerning elacestrant, with ongoing investigations into optimizing treatment options for patients with varying backgrounds and treatment histories. Furthermore, Menarini will feature results from additional studies, including the Phase 3 EMERALD trial, which assesses elacestrant's effectiveness as a standalone therapy in patients previously treated with endocrine therapy.

Elcin Barker Ergun, CEO of the Menarini Group, highlighted the significance of the data to be presented, stating, "The observed progression-free survival outcomes validate the considerable benefits that ORSERDU can provide to patients, which is the focus of our ongoing research initiatives."

Conclusion

As the 2024 San Antonio Breast Cancer Symposium approaches, Menarini Group and Stemline Therapeutics are positioned at the forefront of innovative oncology solutions. With findings that illustrate the promise of ORSERDU and its combination therapies, patients with advanced breast cancer may soon have enhanced treatment options that could significantly improve their quality of life.

The conference serves as an essential opportunity for professionals in the field to engage and share crucial insights that will undoubtedly shape the future landscape of breast cancer treatment.