PARIS, August 17, 2022. Sanofi is discontinuing the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader (SERD). The decision is 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.
On August 17, Sanofi announced that the Phase III AMEERA-5 study of amcenestrant combined with palbociclib in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer was not reached The primary endpoint, will stop the global clinical development program for amcenestrant.
amcenestrant is an investigational oral selective estrogen receptor degrader (SERD) targeting ER, which can bind to ER in breast cancer cells and induce its degradation, thereby reducing the level of estrogen receptors and inhibiting the growth of cancer cells. grow. The decision was based primarily on the results of an interim analysis of the Phase III AMEERA-5 clinical study evaluating amcenestrant in combination with palbociclib versus letrozole in combination with palbociclib in patients with ER+/HER2- advanced breast cancer.
The results showed that the combination of amcenestrant and palbociclib did not meet the prespecified boundary for continuation of the trial compared with the control group and suggested discontinuation of the trial. No new safety signals were observed in this trial. Trial participants will be treated with letrozole in combination with palbociclib or other appropriate modalities, as determined by their physician. The company will continue to review the data and plans to share the results with the scientific community in the future. In addition, all other studies of amcenestrant, including those in early breast cancer (AMEERA-6), will be discontinued.
AMEERA-5 is a randomized, double-blind Phase III clinical trial designed to evaluate the efficacy and safety of amcenestrant combined with the CDK4/6 inhibitor palbociclib in the first-line treatment of ER+/HER2- advanced breast cancer. The trial included 1068 patients who had not received any prior systemic anticancer therapy for advanced disease and were randomized 1:1 to receive amcenestrant or letrozole plus palbociclib.
AMEERA-6 is a randomized, double-blind Phase III trial evaluating amcenestrant versus tamoxifen in hormone receptor-positive early breast cancer patients who discontinue adjuvant aromatase inhibitor (AI) therapy due to treatment-related toxicity Efficacy and safety in cancer patients.
In March, Sanofi announced that the Phase II AMEERA-3 trial failed to meet its primary endpoint of improving progression-free survival (PFS) in patients with ER+/HER2- advanced or metastatic breast cancer.
“While we are disappointed by this result, our study will further advance the scientific understanding of endocrine therapy for breast cancer patients,” said Dr. John Reed, Sanofi’s Global Head of R&D. “We sincerely thank all those involved in this clinical development program. Patients, families and healthcare workers. Oncology remains a priority area for Sanofi, and we will continue our transformative research to develop new medicines for cancer patients.”
