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Sanofi Partners With Academic Cooperative Groups To Study Amcenestrant In Breast Cancer

Sanofi (SNYNF,SNY) said that it has partnered with academic cooperative groups to initiate a pivotal trial of an oral selective estrogen receptor degrader or SERD in the adjuvant setting.

The academic cooperative groups are the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT).

The Phase 3 AMEERA-6 study will evaluate the efficacy and safety of Sanofi's amcenestrant verses tamoxifen for women with estrogen receptor-positive (ER+) breast cancer who were unable to continue their adjuvant aromatase inhibitor (AI) therapy.

Sanofi believes that amcenestrant, an investigational oral SERD, has the potential to become a best-in-class oral endocrine backbone therapy.

Amcenestrant is an oral SERD that antagonizes 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 deal, 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 United States portion of the study.

Sanofi noted that it will conduct the 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.

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