KEY TAKEAWAYS
- Phase 2 AMEERA-3 trial evaluated amcenestrant as monotherapy vs endocrine treatment of physician’s choice in patients with locally advanced.
- The trial’s primary objective was to determine whether amcenestrant improvement PFS was assessed by an independent central review.
- The trial did not meet its primary endpoint of improving PFS as assessed by an independent central review.
- No new safety signals were identified, and the safety profile of the amcenestrant was consistent with earlier studies.
- As part of a comprehensive research and development effort, amcenestrant’s potential is an orally administered endocrine backbone therapy.
- The trial is complete, and the Phase 3 AMEERA-6 trial is enrolling in collaboration with BIG, EORTC, and AFT.
The optimized oral selective estrogen receptor degrader (SERD) amcenestrant, tested in Phase 2 clinical trial called AMEERA-3, did not improve progression-free survival (PFS) as measured by an independent central review. Amcestrant monotherapy was compared to the endocrine treatment of the physician’s choice in a trial of patients with locally advanced or metastatic estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer who had advanced on or after hormonal therapies.
The safety profile of amcenestrant in AMEERA-3 was comparable with previous research, and no new safety indications were detected. Patients with ER+, HER2- locally advanced or metastatic breast cancer who had previously been treated with hormonal therapies participated in AMEERA-3, an open-label, randomized Phase 2 trial assessing the
amcenestrant’s efficacy and safety as a monotherapy compared to the physician’s choice of a single-agent endocrine treatment. Amcenestrant versus endocrine monotherapy for progression-free survival was the primary objective of the AMEERA-3 study.
Overall survival was the most important secondary efficacy target, but there were also secondary objectives for response rate, disease control, therapeutic benefit, and duration of response. Health-related quality of life was assessed using patient-reported outcomes, and the study compared the overall safety profiles of the two therapy groups. Amcenestrant’s extensive development program is intended to assess its utility as an oral endocrine backbone therapy across treatment lines, such as in the adjuvant setting for patients with early-stage disease, in combination with palbociclib for patients with ER+/HER2- metastatic breast cancer (AMEERA-5), and as a single agent in later-stage disease (AMEERA-3) (AMEERA-6).
The AMEERA-5 Phase 3 clinical trial, set to begin in late 2020, has reached its target enrollment. As a result, the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC), and the Alliance Foundation Trials (AFT) have joined forces to conduct the Phase 3 AMEERA-6 trial, which is now accepting participants.
Source:https://www.sanofi.com/en/media-room/press-releases/2022/2022-03-14-06-00-00-2402216
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT04059484
Sanofi provides an update on the Phase 2 study evaluating amcenestrant in ER+/HER2- advanced or metastatic breast cancer – Sanofi. (n.d.). Www.sanofi.com. Retrieved April 5, 2023, from https://www.sanofi.com/en/media-room/press-releases/2022/2022-03-14-06-00-00-2402216
