Sanofi Inks Partnership for Late-Stage Trial of Amcenestrant as Add-On Breast Cancer Therapy

Sanofi SA SNY has secured partners for a Phase 3 trial to study amcenestrant versus the hormone therapy tamoxifen in breast cancer.
The Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC), and the Alliance Foundation Trials (AFT) will initiate the pivotal trial.
The AMEERA-6 study will look at amcenestrant versus tamoxifen, a hormonal therapy approved by the FDA in 1998 for women with estrogen receptor-positive breast cancer who prematurely ended standard therapy and are susceptible to a return of the disease.
Amcenestrant, which is an oral selective estrogen receptor degrader (SERD), “has the potential to become a best-in-class oral endocrine backbone therapy,” said Peter Adamson, M.D., global head of oncology development at Sanofi, in a statement.
Sanofi will provide funding and the investigational drug for the global study as the sponsor, while Brussels-based BIG will conduct the study within its network.
EORTC, an academic contract research organization, will manage the study, data analysis, and medical management. AFT, a cancer clinical trial research organization, will handle the U.S. portion of the study.
Two weeks ago, Sanofi presented pooled data of amcenestrant from the phase 1 AMEERA-1 trial, which hit an objective response rate of 34% and a clinical benefit rate of 74% when combined with Pfizer’s approved breast cancer med, Ibrance.
Price Action: SNY shares are up 0.92% at $52.40 during the market session on the last check Friday.

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