Menarini Group Showcases Latest Efficacy Data for Elacestrant in Breast Cancer at ASCO 2025
Menarini Group Showcases Latest Efficacy Data for Elacestrant in Breast Cancer at ASCO 2025
On May 22, 2025, Menarini Group, in collaboration with Stemline Therapeutics, announced the presentation of valuable preliminary efficacy and safety results from the ELEVATE study at the prestigious ASCO 2025 Annual Meeting. This study focuses on patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). The data indicate a significant role for Elacestrant (ORSERDU®) in combination with several targeted therapies, potentially establishing it as a preferred endocrine therapy backbone for this patient population.
The ELEVATE study features an innovative approach by assessing the safety and effectiveness of oral-oral combination treatment regimens designed to navigate the various resistance mechanisms prevalent in ER+/HER2- mBC. By presenting updated preliminary efficacy and safety information, Menarini aims to highlight the therapeutic promise of Elacestrant, particularly in tandem with CDK4/6 inhibitors like ribociclib, palbociclib, and abemaciclib, as well as PI3K/AKT/mTOR pathway inhibitors such as everolimus and alpelisib.
Key Findings from the ELEVATE Study
The recent analysis revealed encouraging preliminary results that contribute to the ongoing research narrative surrounding Elacestrant. Abstract number 1070, presented by Dr. Hope S. Rugo from City of Hope, illustrated positive trends in progression-free survival (PFS) for patients treated with Elacestrant in combination with ribociclib and everolimus. In this study, the recommended phase 2 doses determined were Elacestrant at 345 mg alongside ribociclib at 400 mg, and previously reported doses of Elacestrant and everolimus.
Dr. Rugo noted, “The positive preliminary efficacy and safety results from the combination of Elacestrant with both everolimus and ribociclib are indeed encouraging.” These observations align with past data from the study which also indicated favorable results from the Elacestrant and abemaciclib cohorts.
The ongoing ELEVATE study continues to evolve as data matures, offering hope for the potential of Elacestrant to emerge as a leading component of combination regimens targeting metastatic breast cancer.
Additional Safety Updates and Future Directions
Alongside efficacy data, the presentation at ASCO also included safety data from four other cohorts assessing different combinations with Elacestrant. Abstract number 1079, delivered by author Nancy Chan, encapsulated updated Phase 1b/2 safety results. These findings reaffirmed the combination therapies' safety profiles are consistent with what is known for each targeted therapy used along with standard endocrine treatment.
CEO Elcin Barker Ergun remarked, “The data emphasizes the potential role of Elacestrant as a valuable combination partner within the landscape of treatment for ER+/HER2- metastatic breast cancer.” Menarini is also keen to explore the drug’s efficacy in different patient cohorts, evidenced by their ELEGANT study assessing its application in high-risk early breast cancer.
Menarini's Ongoing Commitment
Menarini's extensive clinical development initiatives spotlight Elacestrant as it undergoes numerous company-sponsored trials to evaluate combinations with both novel and existing therapies in advanced breast cancer contexts. Moreover, they aim to push the boundaries further by investigating Elacestrant's applications across various settings, thereby addressing critical treatment gaps in oncology.
Summary
As a market leader in pharmaceuticals, Menarini Group's efforts in clinical research reflect a commitment to innovation and better patient outcomes in oncological treatments. With the anticipated updates from multiple trials, Elacestrant stands at the forefront, promising new hope for patients battling metastatic breast cancer. The data showcased at ASCO 2025 plays a pivotal role in aligning the medical community towards effectively tackling ER+/HER2- mBC, enhancing therapeutic strategies for improved survival rates and quality of life.
By continuing to broaden their studies and findings, Menarini Group aims to lead the charge in transforming the treatment landscape for breast cancer and beyond.
Topics Health）
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