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Sanofi Discontinues Studies Of Amcenestrant In Breast Cancer

Sanofi (SNYNF) said Wednesday that it has discontinued the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader. The company noted that it will discontinue all other studies of amcenestrant, including in early-stage breast cancer.

The decision was based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial evaluating amcenestrant in combination with palbociclib compared with letrozole in combination with palbociclib in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

According to the company, an Independent Data Monitoring Committee found that amcenestrant in combination with palbociclib did not meet the prespecified boundary for continuation in comparison with the control arm and recommended stopping the trial. No new safety signals were observed.

Trial participants will be transitioned to letrozole in combination with palbociclib or another appropriate standard of care therapy, as determined by their physician.

In March, Sanofi announced that the Phase 2 AMEERA-3 trial had not met the primary endpoint of improving progression-free survival in patients with ER+/HER2- advanced or metastatic breast cancer.

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