Sanofi Discontinue P-III (AMEERA-5) Trial of Amcenestrant for the Treatment of ER+/HER2- Advanced Breast Cancer
- 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
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