#Italy #Elacestrant #Florence #Menarini Group #Capivasertib

Menarini Group Presents Significant Findings on Elacestrant and Capivasertib in Breast Cancer Treatment

The Menarini Group recently highlighted new data from their Phase 1b/2 ELEVATE study, which explores the combination of elacestrant and capivasertib in patients diagnosed with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). This presentation was delivered at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting held in June.

Overview of ELEVATE Study

The ELEVATE trial is designed to assess both the safety and efficacy of elacestrant in conjunction with various other agents, focusing particularly on overcoming resistance mechanisms in breast cancer. Notably, resistance can arise due to mutations such as ESR1 and PIK3CA that complicate treatment efficacy. The study evaluates patients receiving elacestrant with combinations of CDK4/6 inhibitors (like palbociclib, abemaciclib, and ribociclib) and PI3K/AKT/mTOR pathway inhibitors (including everolimus and alpelisib).

The preliminary analyses presented at ASCO 2026 showed that the elacestrant and capivasertib combination led to a promising median progression-free survival (mPFS) of 11.3 months among participants. Specifically, patients with co-existing ESR1 and PIK3CA mutations experienced an 88.9% disease control rate (DCR) and 66.7% clinical benefit rate (CBR) at the 24-week mark.

Detailed Efficacy Findings

During the presentation, results reflecting the Recommended Phase 2 Dose (RP2D) of elacestrant 345 mg and capivasertib 320 mg were particularly well-received. With a cohort of 31 patients, researchers noted that those treated at this dosage demonstrated significant response rates, including a 33.3% objective response rate (ORR). These figures underscore the potential of this drug combination in managing challenging breast cancer cases where traditional therapies may fall short.

Dr. Sara Tolaney, an expert in breast oncology, expressed her enthusiasm, stating that the combination effectively targets the pressing need for more effective treatments for patients experiencing advanced mBC. Given the manageable safety profile and the capacity to target dual mechanisms, this combination therapy may represent a paradigm shift in treating these patients.

Future Perspectives and Commitment

Elcin Barker Ergun, CEO of Menarini Group, reinforced the company’s ongoing commitment to exploring elacestrant’s potential. The data showcased not only confirms the findings from previous conferences but also illustrates a broad commitment to developing new therapy avenues for cancers that have limited treatment options.

Aside from ELEVATE, additional trials involving elacestrant will be presented at the ASCO meeting, including studies on its usage in various combination regimens and as a standalone treatment option. This extensive range of research indicates a significant investment in improving therapeutic outcomes for breast cancer patients across different stages of the disease.

In summary, the findings from Menarini Group’s ELEVATE study signify a hopeful advancement in the treatment of ER+/HER2- metastatic breast cancer. As the oncology community eagerly anticipates further results, this combination therapy stands poised to transform treatment paradigms and enhance patient care.

For further details regarding Menarini's ongoing studies or information on elacestrant, it’s recommended to refer to the official site or the upcoming ASCO presentations.