The Menarini Group, a global leader in pharmaceuticals and diagnostics, and its subsidiary Stemline Therapeutics, focused on delivering innovative oncology treatments, have partnered with MEDSIR, a top independent clinical research organization in oncology and part of Oncoclínicas & Co., the largest oncology treatment group in Latin America. Together, they presented groundbreaking research on the ADELA clinical trial, which tackles therapeutic resistance in advanced ER+/HER2- breast cancer. The study, unveiled at the 2024 San Antonio Breast Cancer Symposium (SABCS), marks a significant step forward in the search for more effective and personalized treatments for patients with disease progression.
The standard first-line treatment for advanced ER+/HER2- breast cancer typically combines endocrine therapy with CDK4/6 inhibitors. However, ESR1 mutations, which can develop from prior endocrine therapy during metastatic treatment, occur in up to 50% of ER+/HER2- advanced or metastatic breast cancers. These mutations make tumors resistant to endocrine therapy, causing cancer progression. Therefore, testing for ESR1 mutations is essential when metastatic breast cancer (mBC) progresses. Prolonged exposure to endocrine therapy during first-line treatment increases the likelihood of developing ESR1 mutations.
To address this unmet medical need, the ADELA Phase III clinical trial investigates a novel therapeutic combination of elacestrant, an oral next-generation selective estrogen receptor degrader, with everolimus, an mTORC1 inhibitor. This combination is being evaluated in patients with advanced ER+/HER2- breast cancer harboring ESR1 mutations who have experienced progression after standard first-line therapy. Elacestrant’s approval was based on results from the Phase III EMERALD study, while everolimus has demonstrated efficacy in targeting other resistance mechanisms in this cancer type. The elacestrant and everolimus combination has shown promising preliminary efficacy and manageable safety in the Phase 1b/2 ELEVATE study (NCT05563220).
“We are thrilled to collaborate with MEDSIR to advance research into the combination therapy with elacestrant,” said Nassir Habboubi, MD, Chief Medical Officer of Stemline Therapeutics. “Our commitment is to drive innovation in cancer treatment by delivering transformative therapies aimed at improving the lives of people with cancer.”
The ADELA trial is a randomized, double-blind study aimed at evaluating whether the combination of elacestrant and everolimus is more effective in delaying disease progression than elacestrant alone. The study also examines overall survival, toxicity, and the impact on patients’ quality of life.
The ADELA study is a crucial step toward overcoming tumor resistance in patients with ESR1 mutations, working toward more effective and safer treatments.
“At MEDSIR, innovation means not just achieving clinical outcomes but also transforming patients’ lives globally,” said Dr. Antonio Llombart-Cussac, Senior Scientific Leader at MEDSIR. “With ADELA, we aim for less invasive and more accessible treatments that offer hope to patients facing complex disease. This reflects our commitment to personalized, patient-centered medicine, a core element in shaping the future of oncology.”
In addition to its clinical significance, the study could lead to regulatory approval of the therapeutic combination, expanding its use in a broader patient population. The international study spans multiple countries, including Spain, Italy, France, Austria, the Czech Republic, Greece, Germany, and the United Kingdom, highlighting its global relevance in the scientific community.
The ADELA study’s presentation at the prestigious SABCS 2024 underscores MEDSIR’s leadership in oncology research and its dedication to addressing unmet needs in breast cancer treatment. The study is currently active and recruiting patients.
About ORSERDU (elacestrant)
ORSERDU (elacestrant) is approved for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed after at least one line of endocrine therapy.
