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Sanofi oral SERD failed: Only one ADC in the phase 3 tumor pipeline
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Sanofi oral SERD failed: Only one ADC in the phase 3 tumor pipeline.
On August 17, Sanofi announced that it will discontinue the global clinical development program for its investigational oral selective estrogen receptor degrader (SERD) amcenestrant.
The decision was based on the results of a pre-specified interim analysis of the Phase 3 AMERA-5 trial in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer , comparing the efficacy of amcenestrant combined with palbociclib and letrozole combined with palbociclib.
The Independent Data Monitoring Committee (IDMC) found that the combination of amcenestrant and palbociclib did not meet the predetermined limit for continued use compared with the control group and recommended that the trial be discontinued.
Sanofi said all other studies on amcenestrant, including early-stage breast cancer (AMEERA-6), will be discontinued.
Previously, Sanofi had seen the program as a future “endocrine backbone therapy” for breast cancer.
Amcenestrant took a major hit in March, when Sanofi disclosed the failure of an often-delayed phase 2 trial investigating the drug as a monotherapy for ER-positive, HER2-negative breast cancer.
(source:internet, reference only)