Menarini Group, along with its subsidiary Stemline Therapeutics and research partner MEDSIR, presented research at the San Antonio Breast Cancer Symposium 2024 (SABCS) on the ADELA clinical trial. This phase III trial is investigating a combination therapy of elacestrant and everolimus for advanced ER+/HER2- breast cancer patients with ESR1 mutations who have progressed after first-line treatment. The study aims to address the growing challenge of therapeutic resistance in these patients, a significant unmet medical need.
The emergence of ESR1 mutations, often driven by prior endocrine therapy exposure, renders tumors resistant to standard treatments, leading to disease progression. Current treatment options for patients who develop this resistance are limited, emphasizing the crucial need for new therapeutic strategies. The ADELA trial directly addresses this challenge by exploring a combination therapy designed to overcome these resistance mechanisms and improve outcomes for these patients. This research holds significant implications for potentially extending survival and improving quality of life for individuals facing this difficult diagnosis.
The ADELA trial is a randomized, double-blind study comparing the efficacy of elacestrant plus everolimus to elacestrant alone. Elacestrant, an oral selective estrogen receptor degrader, received prior approval based on the EMERALD study results. Everolimus, an mTORC1 inhibitor, has demonstrated the ability to inhibit other resistance mechanisms in this cancer type. Preliminary data from the phase 1b/2 ELEVATE study suggests this combination exhibits efficacy with a manageable safety profile. The ADELA trial’s primary endpoint is progression-free survival, with secondary endpoints including overall survival, toxicity, and quality of life. The trial’s international scope, encompassing multiple countries across Europe, highlights its global significance.
The ADELA trial results could significantly impact the treatment landscape for advanced breast cancer. Positive findings could lead to regulatory approval of the elacestrant and everolimus combination, offering a new therapeutic option for patients who have developed resistance to standard endocrine therapies. Furthermore, the trial’s focus on ESR1 mutations represents a move towards more personalized medicine, tailoring treatment strategies to the specific genetic profile of individual tumors. The international collaboration and presentation at a major oncology symposium underscore the importance of this research and its potential to advance the field.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
