Sanofi: amcenestrant program discontinued

(CercleFinance.com) - Sanofi today announced that it is discontinuing the global clinical development program for amcenestrant, an investigational oral selective estrogen receptor deregulator (SERD).


This decision is based on the results of a pre-specified interim analysis of data from the Phase III AMEERA-5 trial, which evaluated amcenestrant, in combination with palbociclib, in patients with advanced breast cancer.

An independent data monitoring committee found that, compared to the control group, amcenestrant did not reach the pre-specified threshold for continued treatment. No new safety signals were observed.

Sanofi plans to share its results with the scientific community in the near future. All other studies with amcenestrant, in particular in early breast cancer (AMEERA-6), will be stopped.


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