Sanofi is partnering with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT), to initiate a pivotal trial of an oral selective estrogen receptor degrader (SERD) in the adjuvant setting. The Phase 3 AMEERA-6 study will evaluate the efficacy and safety of Sanofi’s amcenestrant vs tamoxifen for women with estrogen receptor-positive (ER+) breast cancer who were unable to continue their adjuvant aromatase inhibitor (AI) therapy.
“Together with our research partners, BIG conducts landmark, practice-changing trials that can have a significant impact on the lives of women with breast cancer,” said David Cameron, Chair of the BIG Executive Board. “Adjuvant therapy helps prevent and delay the progression of disease into the later setting. However, current adjuvant therapies, like AIs, can have side effects for some women, which may cause them to discontinue the medication prematurely. Amcenestrant may be a potential option for women in this setting and we look forward to working with Sanofi, EORTC and AFT to investigate this further. We look forward to collaborating with these leading academic networks to investigate amcenestrant in the adjuvant setting through AMEERA-6. Based on encouraging data emerging from our ongoing clinical program, we believe that amcenestrant, an investigational oral SERD, has the potential to become a best-in-class oral endocrine backbone therapy,” said Peter Adamson, Global Development Head, Oncology at Sanofi.
Amcenestrant is an oral SERD that antagonises and degrades the estrogen receptor (ER), resulting in inhibition of the ER signaling pathway. Amcenestrant is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority.
As per the terms of the Pre-Study Agreement, Sanofi will be the sponsor and will provide funding and investigational drug product for the global study. BIG will conduct the study within the BIG network, EORTC will oversee study management and data analysis, as well as the medical management, and AFT will conduct the US portion of the study. Sanofi will conduct this global study in selected countries outside the geographical scope of the academic networks, as further described in a follow-on agreement under negotiation among the four parties. The protocol is being developed in collaboration with all four parties, including AFT, BIG, EORTC and Sanofi.