Menarini and MEDSIR Launch Groundbreaking Phase III Study ADELA for Advanced Breast Cancer Treatment
In a remarkable advancement for breast cancer treatment, Menarini and MEDSIR have disclosed key findings from their phase III clinical trial known as ADELA. This significant international study integrates elacestrant with everolimus, targeting advanced ER+/HER2- breast cancer, particularly in patients with ESR1 mutations. Presented at the prestigious San Antonio Breast Cancer Symposium (SABCS 2024), this research aims to delay disease progression and offers a dual therapeutic strategy for a challenging patient demographic.
The phase III ADELA study is conducted across various countries, emphasizing its global significance and the collaborative nature of cancer research. Menarini, a well-established pharmaceutical and diagnostic company, alongside Stemline Therapeutics and MEDSIR, focuses on developing transformative treatments for oncology. This commitment to innovation is showcased through this clinical trial, which evaluates the efficacy of the drug combination against standard care, addressing a critical need in treating patients whose cancer has progressed despite prior therapy.
The standard first-line treatment for advanced ER+/HER2- breast cancer typically combines hormone therapy with CDK4/6 inhibitors. However, a significant challenge arises when ESR1 mutations develop, a common occurrence in up to 50% of ER+ metastatic breast cancer cases. These mutations often render tumors resistant to hormonal treatments, necessitating the exploration of novel therapeutic options. In response to this unmet medical need, the ADELA trial investigates the promising combination of elacestrant and everolimus, focusing on patients with confirmed ESR1 mutations whose condition has advanced post-first-line treatment.
Elacestrant, a next-generation oral selective estrogen receptor degrader (SERD), is evaluated in conjunction with everolimus, an mTORC1 inhibitor, to identify its potential in overcoming hormonal resistance mechanisms. Preliminary efficacy data, drawn from related studies such as ELEVATE phase 1b/2 (NCT05563220), suggest that this dual-drug regimen could yield a manageable safety profile while significantly impacting tumor progression rates.
Nassir Habboubi, Medical Director at Stemline Therapeutics, expressed enthusiasm regarding the collaboration with MEDSIR, highlighting their shared commitment to catalyzing clinical innovation and improving patient outcomes in oncology. The trial is meticulously designed as a randomized, double-blind study, primarily evaluating whether the combination of elacestrant and everolimus effectively delays disease progression in comparison to elacestrant as a standalone treatment. Additionally, the study is assessing critical benchmarks such as overall survival, toxicity profiles, and the quality of life for participants.
Dr. Antonio Llombart-Cussac, Chief Scientific Officer at MEDSIR, emphasizes that innovation transcends mere clinical results. The ADELA study is a decisive step towards minimizing invasive treatments, making them more accessible to patients confronting the intricate challenges posed by advanced breast cancer. Their mission aligns with the growing trend toward personalized medicine, a crucial component in shaping the future landscape of oncology.
Looking forward, successful results from the ADELA study could lead to regulatory approval of this therapeutic combination, broadening treatment options for patients battling advanced breast cancer. The study's international scope reinforces its critical role in global cancer research, with involvement from countries such as Spain, Italy, France, Austria, Czech Republic, Greece, Germany, and the UK.
The presentation of the ADELA study at SABCS 2024 signifies MEDSIR’s leading position in oncology research and its dedication to addressing the pressing needs of patients facing advanced disease. Currently, the study is active and in the process of patient recruitment, paving the way for what could be a groundbreaking advancement in breast cancer therapy.
The phase III ADELA study is conducted across various countries, emphasizing its global significance and the collaborative nature of cancer research. Menarini, a well-established pharmaceutical and diagnostic company, alongside Stemline Therapeutics and MEDSIR, focuses on developing transformative treatments for oncology. This commitment to innovation is showcased through this clinical trial, which evaluates the efficacy of the drug combination against standard care, addressing a critical need in treating patients whose cancer has progressed despite prior therapy.
The standard first-line treatment for advanced ER+/HER2- breast cancer typically combines hormone therapy with CDK4/6 inhibitors. However, a significant challenge arises when ESR1 mutations develop, a common occurrence in up to 50% of ER+ metastatic breast cancer cases. These mutations often render tumors resistant to hormonal treatments, necessitating the exploration of novel therapeutic options. In response to this unmet medical need, the ADELA trial investigates the promising combination of elacestrant and everolimus, focusing on patients with confirmed ESR1 mutations whose condition has advanced post-first-line treatment.
Elacestrant, a next-generation oral selective estrogen receptor degrader (SERD), is evaluated in conjunction with everolimus, an mTORC1 inhibitor, to identify its potential in overcoming hormonal resistance mechanisms. Preliminary efficacy data, drawn from related studies such as ELEVATE phase 1b/2 (NCT05563220), suggest that this dual-drug regimen could yield a manageable safety profile while significantly impacting tumor progression rates.
Nassir Habboubi, Medical Director at Stemline Therapeutics, expressed enthusiasm regarding the collaboration with MEDSIR, highlighting their shared commitment to catalyzing clinical innovation and improving patient outcomes in oncology. The trial is meticulously designed as a randomized, double-blind study, primarily evaluating whether the combination of elacestrant and everolimus effectively delays disease progression in comparison to elacestrant as a standalone treatment. Additionally, the study is assessing critical benchmarks such as overall survival, toxicity profiles, and the quality of life for participants.
Dr. Antonio Llombart-Cussac, Chief Scientific Officer at MEDSIR, emphasizes that innovation transcends mere clinical results. The ADELA study is a decisive step towards minimizing invasive treatments, making them more accessible to patients confronting the intricate challenges posed by advanced breast cancer. Their mission aligns with the growing trend toward personalized medicine, a crucial component in shaping the future landscape of oncology.
Looking forward, successful results from the ADELA study could lead to regulatory approval of this therapeutic combination, broadening treatment options for patients battling advanced breast cancer. The study's international scope reinforces its critical role in global cancer research, with involvement from countries such as Spain, Italy, France, Austria, Czech Republic, Greece, Germany, and the UK.
The presentation of the ADELA study at SABCS 2024 signifies MEDSIR’s leading position in oncology research and its dedication to addressing the pressing needs of patients facing advanced disease. Currently, the study is active and in the process of patient recruitment, paving the way for what could be a groundbreaking advancement in breast cancer therapy.
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