#USA #San Antonio #ORSERDU #Elacestrant #Menarini Group

Menarini Group Highlights ORSERDU® at SABCS 2024

The Menarini Group, a prominent player in the pharmaceutical and diagnostics sector, is set to present compelling new findings on ORSERDU® (Elacestrant) at the San Antonio Breast Cancer Symposium (SABCS) 2024. This event, scheduled from December 10 to December 13, promises to be a pivotal moment in the conversation about advanced breast cancer treatments, particularly for patients dealing with ER-positive, HER2-negative metastatic breast cancer (mBC).

These updated results emphasize the efficacy and safety of ORSERDU in real-world settings, particularly for patients who have exhausted prior endocrine therapies. Initial findings suggest a median real-world progression-free survival (rwPFS) of 6.8 months across diverse patient populations. Notably, individuals with one to two lines of prior endocrine therapy in mBC experienced an extended median rwPFS of 8 months. This data compels oncologists to reassess treatment protocols, reinforcing the importance of integrating liquid biopsies for ESR1 mutation testing at each stage of disease progression.

Overview of ORSERDU® (Elacestrant)

ORSERDU® is distinguished as the first oral selective estrogen receptor degrader (SERD) approved for treating ESR1-mutated tumors, which feature in nearly half of all advanced ER-positive, HER2-negative breast cancers. Since its FDA approval in January 2023, the clinical picture surrounding ORSERDU has evolved, providing robust insights into its role in modern mBC treatment strategies.

Dr. Virginia Kaklamani, a leading breast cancer expert from MD Anderson Cancer Center, highlighted the clinical importance of these findings, advocating for ubiquitous ESR1 mutation screening during treatment progression to fine-tune patient care effectively.

Insights from Combination Therapy Studies

In addition to the exciting data on monotherapy, the symposium will present compelling results from ongoing trials investigating ORSERDU in combination with Abemaciclib. Both the ELECTRA and ELEVATE studies focus on refining treatment options for patients facing resistance to traditional therapies. Updated analyses reveal a median PFS of 8.6 months for the combined treatment, with particularly favorable outcomes for those harboring ESR1 mutations.

Dr. Hope Rugo from the University of California, San Francisco, expressed optimism about these combination therapy results, noting that their safety profile remains consistent with previously documented data. These findings reinforce the potential of Elacestrant as a backbone treatment in novel combination regimens for metastatic breast cancer.

Menarini reveals that neither combination therapy has shown new toxicity signals, offering further reassurance to treating physicians and their patients. The analysis indicates tolerable side effects, predominantly gastrointestinal in nature, including mild to moderate instances of nausea and diarrhea, aligning with expectations based on the pharmacological profiles of the agents involved.

Future Explorations and Clinical Programs

Menarini is committed to advancing its extensive clinical research agenda for Elacestrant not only as a standalone treatment but as part of innovative combination therapies. The SABCS presentation will also feature relevant data from the Phase 3 EMERALD study and various ongoing clinical trials.

Elcin Barker Ergun, the CEO of Menarini Group, expressed enthusiasm about these advancements, noting the significant benefits that ORSERDU brings to oncologists and their patients. The company aims to broaden the potential application of Elacestrant across diverse patient demographics, ensuring that the treatments evolve alongside scientific discoveries and patient needs.

The promising findings showcased at SABCS 2024 signify a forward leap in the fight against advanced breast cancer. As Menarini continues to pursue innovative oncology strategies, the insights shared at this symposium may redefine therapeutic pathways and inspire future research endeavors in the breast cancer landscape.

This year’s symposium holds the potential to spark crucial changes in treatment approaches, ultimately benefiting patients navigating the complexities of metastatic breast cancer.