Menarini and MEDSIR Present Phase III ADELA Study: New Strategy for Advanced Breast Cancer

Menarini Group, Stemline Therapeutics, and MEDSIR have presented groundbreaking research on the ADELA clinical trial, which targets therapeutic resistance in advanced ER+/HER2- breast cancer. This research was shared at the San Antonio Breast Cancer Symposium 2024 (SABCS). ADELA is a Phase III study exploring the combination of elacestrant, a selective estrogen receptor degrader, and everolimus, an mTORC1 inhibitor, to treat advanced breast cancer with ESR1 mutations, a mutation linked to resistance to standard endocrine therapy.

Up to 50% of advanced ER+/HER2- breast cancers will develop ESR1 mutations, causing tumors to resist endocrine treatments and progress. Current treatment for this condition involves endocrine therapy combined with CDK4/6 inhibitors, but ESR1 mutations can undermine its effectiveness. The ADELA trial investigates whether combining elacestrant with everolimus can offer superior efficacy in delaying disease progression compared to elacestrant alone. This builds on positive findings from the Phase 1b/2 ELEVATE study.

The trial aims to evaluate various factors, including overall survival, toxicity, and quality of life for patients with advanced breast cancer who have progressed after standard treatment. The goal is to advance safer and more effective treatments, addressing the challenge of tumor resistance.

“The ADELA trial is a significant step toward personalized cancer treatments,” said Dr. Nassir Habboubi, Chief Medical Officer of Stemline Therapeutics. “We aim to offer innovative therapies that extend the lives of cancer patients.”

Dr. Antonio Llombart-Cussac, Senior Scientific Leader at MEDSIR, emphasized that the ADELA study represents a leap toward more accessible and less invasive treatments. The international study spans several countries, including Spain, Italy, France, and the UK, highlighting its global importance.

With its potential to lead to regulatory approval, the ADELA trial could significantly expand treatment options for patients with advanced breast cancer. The study’s presentation at SABCS 2024 underscores MEDSIR’s leadership in oncology research and commitment to addressing unmet needs in breast cancer treatment. The study is ongoing and actively recruiting patients.

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