Menarini Group Unveils Promising New Findings from ELEVATE Study on Elacestrant and Capivasertib for ER+, HER2- Metastatic Breast Cancer

On May 29, 2026, Menarini Group, together with its subsidiary Stemline Therapeutics, presented critical data from its Phase 1b/2 ELEVATE study at the American Society of Clinical Oncology (ASCO) Annual Meeting. This groundbreaking study focuses on the combination of elacestrant and capivasertib in patients suffering from ER+, HER2- metastatic breast cancer (mBC).

Key Takeaways from the ELEVATE Study

The presented findings primarily focus on the preliminary safety and effectiveness of elacestrant in conjunction with capivasertib. This combination aims to target key resistance mechanisms in patients who are facing ER+/HER2- mBC, including patients with ESR1 and PIK3CA mutations. The ELEVATE trial assesses different treatment regimens, examining elacestrant alongside renowned CDK4/6 inhibitors and drugs involved in the PI3K/AKT/mTOR pathway.

Efficacy and Safety Data

The preliminary results showcased in Poster 1098 revealed that out of 31 patients treated with the recommended dose, there was an encouraging median progression-free survival (mPFS) of 11.3 months, which is quite promising compared to the historical benchmarks. In those with concurrent ESR1 and PIK3CA mutations, the mPFS was recorded at 10.9 months. Remarkably, the overall disease control rate was pegged at 88.9%.

Dr. Sara Tolaney from Dana-Farber’s Breast Oncology Division stated, “The combination of elacestrant and capivasertib fills a significant unmet need for patients with ER+ and HER2- mBC with PI3K pathway alterations. The data suggest a potentially extended clinical benefit with a manageable safety profile.” These findings hint at the chance of a synergistic effect that targets the dual mutations, allowing for an effective treatment avenue without the necessity for sequential therapy strategies.

Menarini's Commitment to Innovation

Elcin Barker Ergun, CEO of Menarini Group, expressed optimism about the ongoing potential of elacestrant across multiple combinations for treating ER+/HER2- metastatic breast cancer. The comprehensive approach, which includes early-stage breast cancer clinical trials, underlines Menarini’s dedication to providing transformative therapies for patients globally.

The ASCO conference was also a platform for other relevant updates concerning elacestrant, specifically its utility in cases of early-stage breast cancer and among patients with brain metastases.

Future Directions

As the clinical journey of elacestrant continues, further studies will focus on defining its role in combination with everolimus and other agents, ensuring a multifaceted approach to combat breast cancer effectively. The breadth of Menarini’s clinical studies reflects their commitment to addressing unmet medical needs while seeking potential breakthroughs in cancer treatment.

Conclusion

Menarini’s presentation at the ASCO 2026 underscored the promising potential of elacestrant and capivasertib as a dual treatment strategy for patients grappling with ER+, HER2- metastatic breast cancer. As trials progress, the hope for more effective and tailored therapies to meet the specific challenges faced by these patients remains robust.