(Boursier.com) — New setback for Sanofi. The laboratory is ending the worldwide clinical development program for amcenestrant, an experimental selective estrogen receptor deregulator (SERD) taken by mouth. This decision is based on the results of a pre-specified interim analysis of data from the Phase III AMEERA-5 trial which evaluated amcenestrant in combination with palbociclib, compared to letrozole in combination with palbociclib, in patients advanced estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 (HER2-) negative breast cancer.
An independent data monitoring committee found that, compared to the control group, amcenestrant in combination with palbociclib did not reach the pre-specified threshold for continued treatment and therefore recommended stopping the trial . No new safety signal was observed. Trial participants will be switched to treatment with letrozole in combination with palbociclib or another standard treatment, at the choice of their doctor.
The company will continue to evaluate data from the trial and plans to communicate its results to the scientific community soon. All further studies of amcenestrant, particularly in the treatment of early stage breast cancer (AMEERA-6), will be discontinued.
Dr. John Reed, Ph.D, Global Head, Research and Development at Sanofi, says: “Although disappointed by these results, our research will nevertheless allow us to deepen our understanding of endocrine treatments for breast cancer. We are extremely grateful to the patients, their families and healthcare professionals who have taken part in the amcenestrant clinical development program Oncology remains a priority area for Sanofi and we will continue our innovative research to develop new medicines for people with cancer”.
Last March, Sanofi announced that its Phase II AMEERA-3 trial failed to meet its primary endpoint of improving progression-free survival in patients with ER+/HER2 breast cancer. – metastatic or advanced stage.
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