FRANCE- Sanofi has decided to stop developing amcenestrant, a once-promising breast cancer medication, after a second unsuccessful clinical trial, striking a setback to its pipeline of potential new medicines.
The French multinational pharmaceutical and healthcare company announced that the choice is based on the results of an interim analysis that was predetermined for the Phase 3 AMEERA-5 study.
The study compared the effects of amcenestrant and palbociclib against those of letrozole and palbociclib in patients with advanced breast cancer that was ER+/HER2-negative.
An Independent Data Monitoring Committee (IDMC) determined that the combination of amcenestrant and palbociclib failed to surpass the predetermined threshold for continuation when compared to the control arm and advised terminating the experiment.
The company further stated that there were no new warning signs of safety. The transition of trial participants to letrozole combined with palbociclib or another suitable standard of care treatment will be decided by their doctor.
The business will keep analyzing the data, and it intends to eventually inform the scientific community of its findings.
“While we are disappointed by this outcome, our research will further the scientific understanding of endocrine therapies in people with breast cancer.”
Amcenestrant will no longer be used in any further research, including the early-stage breast cancer (AMEERA-6) study.
“While we are disappointed by this outcome, our research will further the scientific understanding of endocrine therapies in people with breast cancer,” said John Reed, worldwide head of research and development at Sanofi.
He continued that the company appreciates the participation of the patients, families, and medical staff in the amcenestrant clinical development program.
A critical trial for Sanofi’s oral selective estrogen receptor degrader (SERD) amcenestrant ended in failure earlier in the year.
The company turned to research on individuals with earlier stages of the disease after an amcenestrant’s failure as a second-line or later treatment for ER+/HER2- progressed or metastatic breast cancer.
In the second quarter of 2021, Sanofi was planned to deliver data from the AMEERA-3 trial.
The analysts at Jefferies observed “widespread skepticism” over the chances of amcenestrant turning the needle in second-line or later patients as the aim drifted deeper into 2021 and ultimately well into 2022.
The setback, according to analysts, has raised concerns about the robustness of Sanofi’s medication pipeline and ran the risk of making the company dependent on the very successful eczema and asthma treatment Dupixent.
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