Amcenestrant or letrozole's pharmacodynamic (PD) activity in postmenopausal individuals with ER+/HER2 primary breast cancer will be evaluated in the AMEERA-4 preoperative window-of-opportunity investigation.
Regardless of the baseline (BL) ESR1 mutation status, amcenestrant (Sanofi), an optimised oral selective ER degrader (SERD) that antagonises and degrades the ER, has shown promising early safety and anticancer effectiveness in postmenopausal patients with metastatic breast cancer that is ER+/HER2 positive. The AMEERA-4 (NCT04191382) is a Phase II preoperative window-of-opportunity research that used paired biopsies to analyse biomarkers to assess the PD activity of two dose levels of amcenestrant or letrozole. No formal statistical comparisons were made because trial enrolment in AMEERA-4 was voluntarily ended early when useful evidence supporting adjuvant development became available.
95 of the 105 randomly assigned patients (amcenestrant 400 mg, amcenestrant 200 mg, and letrozole) received treatment, and pre- and post-treatment Ki67 data were available, according to a central evaluation. The features of the BL patient and tumour were not significantly out of equilibrium. The geometric least squares means (LSM) estimate of the Ki67 reduction for amcenestrant 400 mg, amcenestrant 200 mg, and letrozole was 75.9%, 68.2%, and 77.7%, respectively.
In terms of safety, letrozole had a TRAE incidence of 25.7 percent, amcenestrant 400 mg had a TRAE incidence of 21.2 percent, and amcenestrant 200 mg had a TRAE incidence of 22.2 percent.
Conclusion
The 200 mg QD dose of amcenestrant was chosen for our ongoing investigation in the adjuvant context; AMEERA-6; based on PD activity and safety, emerging findings from AMEERA-4, and other ongoing amcenestrant clinical trials (NCT05128773). Sanofi aims to move quickly and make amcenestrant the first SERD in the adjuvant context, as evidenced by the failure of AMEERA-3 and its decision to stop the AMEERA-4 investigation midway through while beginning the AMEERA-6 research in the bigger adjuvant setting pools.
Roche and Eli Lilly are also testing their SERDs in the adjuvant context, joining Amcenestrant in the competition. A broad promise for this patient population in combination and as monotherapy has been shown by the advent of numerous novel selective oestrogen receptor degraders (SERDs) in the ESR1 region.
Breast Cancer Companies- Gilead, Sanofi, AstraZeneca, Eli Lilly, Radius Health, Sermonix Pharmaceuticals, Roche, Veru Pharma, and others.
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