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Menarini Group's Elacestrant Presentation at ASCO 2025

On May 25, 2025, Menarini Group unveiled crucial data regarding Elacestrant (ORSERDU®) at the annual meeting of the American Society of Clinical Oncology (ASCO). This innovative hormone therapy is under investigation for its effectiveness in treating patients with metastatic breast cancer (mBC) that is estrogen receptor-positive (ER+) and HER2-negative (HER2-). The updates also include preliminary efficacy analyses from the ELEVATE clinical trial, which studies the combination of Elacestrant with other targeted therapies.

Background on Elacestrant

Elacestrant is an oral medication designed to target estrogen receptors in cancer cells, showcasing potential as a foundational therapy for ER+/HER2- breast cancer. This therapy offers new hope to patients whose cancer has continued to progress despite previous treatments. By presenting these findings at ASCO 2025, Menarini emphasizes its commitment to advancing cancer treatment options.

Key Findings from ELEVATE Trial

The ELEVATE trial focuses on assessing the safety and efficacy of Elacestrant in combination with various targeted agents. Six different treatment regimens are being evaluated, including those combining Elacestrant with ribociclib, palbociclib, and everolimus. The presentation highlighted updated efficacy data showing favorable preliminary results in progression-free survival (PFS) for patients receiving Elacestrant with ribociclib and everolimus. The recommended phase 2 dosing (RP2D) for Elacestrant has been established at 345 mg alongside ribociclib at 400 mg.

Dr. Hope S. Rugo, a noted oncologist from the City of Hope Comprehensive Cancer Center, remarked on the encouraging preliminary results. “The positive outcomes in efficiency and safety when combined with ribociclib and everolimus are promising for the future of treatment in metastatic breast cancer,” she stated. This combination therapy could potentially standardize treatment regimens and improve overall patient outcomes.

Safety Profile and Additional Studies

The safety data from the ongoing phases of the ELEVATE trial have also been reassuring. Severe adverse effects were reported in only 12% of patients, which correlated with known safety profiles of the included therapies. Moreover, an ongoing study, named ELEGANT, is evaluating the potential of Elacestrant in patients at high risk for recurrence in early-stage breast cancer, further expanding its applicability.

Elcin Barker Ergun, CEO of Menarini Group, underlined Elacestrant's versatility, stating, “These results emphasize its value in combination therapy for ER+/HER2- breast cancer treatment.” The company also anticipates further updates and presentations related to Elacestrant at ASCO, which might provide more insightful data regarding its use across various patient populations.

Future Directions

The landscape of breast cancer treatment is rapidly evolving, and the data presented at ASCO 2025 could represent a significant shift towards integrated therapy approaches that include Elacestrant. Menarini's ongoing dedication to researching innovative solutions, alongside collaborations and partnerships, is essential for developing comprehensive treatment strategies against breast cancer.

Patients and clinicians alike are likely to benefit from the insights and advancements presented at this year’s ASCO meeting, marking a pivotal moment in the quest for effective breast cancer therapies. As research continues, hope grows for improved patient outcomes and quality of lives impacted by this challenging disease.