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

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  • 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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Posted In: BiotechNewsHealth CareFDAGeneralbreast cancerBriefsPhase 3 Trial
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