#Italy #Menarini #Elacestrant #Florence #Capivasertib

Menarini Group Presents New Data from ELEVATE Study

The Menarini Group, a leading international pharmaceutical and diagnostics company, has unveiled promising new data from the ELEVATE Phase 1b/2 study. This research focuses on the combination of elacestrant and capivasertib in patients suffering from ER+, HER2- metastatic breast cancer (mBC). The results will be shared during the prestigious annual meeting of the American Society of Clinical Oncology (ASCO) 2026.

Overview of the ELEVATE Study

The main goal of the ELEVATE study is to evaluate the safety and preliminary efficacy of the combination therapy of elacestrant, a novel oral treatment, with capivasertib, an innovative agent targeting key signaling pathways involved in cancer progression. This combination aims to counteract various resistance mechanisms observed in patients with ER+/HER2- metastatic breast cancer.

The study included multiple treatment regimens, exploring elacestrant in conjunction with a range of agents, including CDK4/6 inhibitors such as palbociclib, abemaciclib, and ribociclib, as well as PI3K/AKT/mTOR inhibitors like everolimus, alpelisib, and capivasertib.

Key Findings

The aggregated results presented at ASCO 2026 showcase the interim safety and efficacy for the recommended dose cohort of 31 patients treated with elacestrant (258-345 mg) and capivasertib (320-400 mg). Impressively, the data highlighted a median progression-free survival (mPFS) of 11.3 months across the cohort. In particular, patients with concurrent mutations in the ESR1 and PIK3CA genes exhibited a median PFS of 10.9 months.

Notably, the disease control rate (DCR) reached 88.9%, while the clinical benefit rate (CBR) was established at 66.7% at 24 weeks, and the objective response rate (ORR) was 33.3%. All patients who achieved an objective response had these gene mutations, underlining the potential of this combination therapy to target specific molecular alterations effectively.

Clinical Implications

Dr. Sara Tolaney from the Dana-Farber Cancer Institute emphasized the significance of these results, noting their potential to address unmet medical needs for patients with ER+/HER2- metastatic breast cancer and concurrent mutations in the targeted genes. The combination appears to provide manageable safety profiles while potentially offering prolonged clinical benefits without the necessity for sequential monotherapy approaches that tackle each individual target separately.

Elcin Barker Ergun, CEO of Menarini Group, expressed enthusiasm regarding the data, reiterating the company's commitment to enhancing innovative treatment options for metastatic breast cancer. The depth of the study designs across various settings—including early-stage breast cancer—reflects Menarini's ambition to contribute significantly to oncology advancements.

Future Directions

The ELEVATE study facts presented will be complemented by additional findings related to elacestrant's efficacy in upcoming ASCO presentations. Some notable studies include and their respective details:

• - ADELA: A randomized Phase 3 trial evaluating elacestrant in combination with everolimus versus placebo.
• - ELECTRA: A Phase 1b/2 study assessing elacestrant with abemaciclib for brain metastases in ER+/HER2- breast cancer.
• - ELEGANT: A large Phase 3 study comparing elacestrant versus standard hormonal therapy in high-risk, early-stage breast cancer patients.

Menarini Group remains dedicated to advancing research in oncology, and these findings reaffirm their position at the forefront of innovative treatment solutions. The ongoing trials and subsequent findings will continue to shape the landscape for patients battling metastatic breast cancer, offering hope and potential new therapeutic avenues.

For further details on the ELEVATE study and related trials, please refer to the Menarini Group’s latest communications and ASCO 2026 updates.