Shots:
The company discontinued the P-III (AMEERA-5) trial evaluating the efficacy and safety of amcenestrant + palbociclib vs letrozole + palbociclib in a ratio (1:1) in 1068 patients with ER+/HER2- advanced breast cancer
The decision was based on the prespecified interim analysis which showed that P-III (AMEERA-5) trial failed to meet the prespecified boundary over the control arm while no new safety signals were observed
The company will continue to review the data and intends to eventually inform the scientific community of its findings. All additional amcenestrant studies will discontinue, incl. the (AMEERA-6) study in early-stage breast cancer
Ref: Globenewswire | Image: Sanofi
