Benzinga | Jun 4, 2021 10:11AM EDT

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

* Sanofi SA (NASDAQ: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.