#Italy #Menarini #Elacestrant #Florence #Capivasertib

Menarini Group's ELEVATE Study at ASCO 2026

The Menarini Group recently showcased groundbreaking findings from the ELEVATE Phase 1b/2 study at the 2026 American Society of Clinical Oncology (ASCO) annual meeting. The research investigates the potential of Elacestrant combined with Capivasertib, targeting women suffering from ER-positive, HER2-negative metastatic breast cancer (mBC). The preliminary results unveiled underscore the safety and initial effectiveness of this combination therapy.

Promising Safety and Efficacy Outcomes

The ELEVATE study aims to tackle significant resistance mechanisms commonly seen in ER+/HER2- mBC patients. This includes targeting concurrent ESR1 and PIK3CA mutations that complicate treatment. The study encompasses a total of six treatment regimens that test Elacestrant together with various targeted therapies, including CDK4/6 inhibitors such as Palbociclib, Abemaciclib, and Ribociclib, as well as PI3K/AKT/mTOR pathway inhibitors like Everolimus, Alpelisib, and Capivasertib.

Among participants receiving the recommended Phase 2 dose (RP2D), initial data shows median progression-free survival (mPFS) indicating favorable outcomes. Specifically, the results highlight an impressive disease control rate (DCR) of 88.9% and a clinical benefit rate after 24 weeks (CBR24) of 66.7%. Additionally, 33.3% of patients recorded objective response rates (ORR) demonstrating the therapeutic potential of this combination, particularly among those with concurrent ESR1 and PIK3CA mutations.

Insights from Key Opinion Leaders

Dr. Sara Tolaney, a prominent figure in breast oncology, praised the results for addressing an unmet medical need in ER+/HER2- mBC patients, especially concerning those with alterations in the PI3K signaling pathway. She emphasized that these encouraging preliminary findings could lead to extended clinical benefits while maintaining a manageable safety profile. The ability to simultaneously address both ESR1 and PIK3CA mutations could potentially mitigate the need for sequential targeting therapies, an often lengthy approach.

Elcin Barker Ergun, CEO of Menarini Group, reinforced the positive outlook on Elacestrant's clinical benefits, highlighted by its deployment in numerous combinations across various studies. They are committed to developing groundbreaking solutions for cancer patients, showcasing evidence that supports both early-stage and metastatic breast cancer indications for their treatments.

Upcoming Presentations at ASCO 2026

Aside from the ELEVATE study, additional relevant data highlighting Elacestrant's efficacy is set to be presented at ASCO. Here’s a summary of noteworthy presentations:

• - Elacestrant in combination with Capivasertib: Update from ELEVATE, Phase 1b/2 umbrella study (Abstract 1098).
• - ADELA: A randomized Phase 3 trial comparing Elacestrant with Everolimus against placebo in ER+/HER2- advanced breast cancer patients (Abstract TPS1154).
• - ELECTRA: An open-label multicenter study on Elacestrant combined with Abemaciclib for patients with HER2 mBC (Abstract TPS1155).
• - ELEGANT: The efficacy of Elacestrant versus standard endocrine therapy in early breast cancer patients with lymph node positivity (Abstract TPS1153).

These initiatives illustrate Menarini and Stemline Therapeutics' dedication to combating breast cancer through innovative treatments and commitment to patient health.

For more information, consult Menarini’s official website and follow upcoming studies in the clinical development pipeline focusing on breast cancer treatment.