Menarini and MEDSIR Unveil Phase III Study ADELA for Advanced Breast Cancer Treatment

In an important advancement in breast cancer treatment, Menarini Group together with MEDSIR presented the groundbreaking results of the ADELA Phase-III study. This international clinical trial explores a novel therapeutic option for patients suffering from advanced ER+/HER2- breast cancer characterized by ESR1 mutations. The combination of Elacestrant and Everolimus aims to combat the progression of this challenging cancer subtype, especially following the failure of standard therapies.

Background of the Study

The ADELA study was revealed at the prestigious San Antonio Breast Cancer Symposium 2024 (SABCS), a cornerstone event in oncology that highlights innovative research and treatments. The collaboration between Menarini, MEDSIR, and Stemline Therapeutics (a subsidiary of Menarini) signifies a collective effort to address the unmet medical needs of women with advanced breast cancer, particularly those experiencing treatment resistance due to mutations in the ESR1 gene.

ESR1 mutations can emerge in patients with metastatic disease who have undergone prior endocrine therapies. As many as 50% of ER+ HER2-negative metastatic breast cancers develop these mutations, leading to resistance against traditional endocrine treatments. This necessitates the evaluation of new combination therapies that can effectively target these resistant tumor profiles.

The Study Design

The ADELA Phase-III study is an international, randomized, double-blind trial investigating the efficacy of the Elacestrant and Everolimus combination versus Elacestrant monotherapy. The primary goal is to determine whether this combination can significantly delay disease progression in patients with ESR1 mutations who have previously been treated with standard first-line therapy. Additional aspects such as overall survival rates, toxicity profiles, and the impact on patients' quality of life will also be assessed.

Results and Implications

The preliminary findings from related studies have shown Elacestrant's promise as a next-generation selective estrogen receptor degrader (SERD), and Everolimus's effectiveness in inhibiting resistance mechanisms. Notably, the ELEVATE study provided encouraging results regarding the safety and efficacy of combining these two agents, which has fueled the design of the ADELA trial.

Dr. Nassir Habboubi, the Chief Medical Officer at Stemline Therapeutics, spoke on the collaboration's importance, stating, “We are committed to driving innovation in cancer treatment by delivering groundbreaking therapies aimed at extending the lives of patients facing serious health challenges.”

A Global Initiative

The ADELA study not only aims at achieving significant clinical milestones but also seeks to pave the way for regulatory approval of this combination therapy, which could become critical in treating larger populations of women with advanced breast cancer. Countries participating in the study include Spain, Italy, France, Austria, the Czech Republic, Greece, Germany, and the United Kingdom, reflecting a broad international consensus on its scientific relevance.

Dr. Antonio Llombart-Cussac, the Scientific Director at MEDSIR, emphasized the transformative nature of this research: “Our definition of innovation extends beyond achieving clinical outcomes; it’s about altering the global landscape of patient care. ADELA represents our commitment to developing less invasive, more accessible treatment options that can provide hope to patients grappling with the most complex forms of disease.”

Conclusion

In conclusion, the ADELA Phase-III study signifies a key advancement in understanding and treating challenges associated with ESR1 mutations in advanced breast cancer. With active recruitment underway, the study stands poised to deliver critical insights that could reshape therapeutic strategies in this field and improve outcomes for countless patients worldwide.

Additional Information

Elacestrant, marketed as ORSERDU, is indicated for advanced or metastatic breast cancer that is ER-positive and HER2-negative, specifically for patients who have progressed after at least one line of endocrine therapy. The comprehensive nature of this trial and its implications for patient care shed light on the importance of continual innovation within oncology.

For further details on the clinical trial and to stay updated with the findings, visit Menarini’s official website or MEDSIR’s official site.