Sanofi's Oral SERD Amcenestrant Fails to Improve Progression-Free Survival in Phase II Breast Cancer Trial

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Sanofi's Amcenestrant Breast Cancer Program Recently Faces Setback, Fails Key Clinical Test

On March 14, Sanofi announced the results of the clinical trial (AMEERA-3) for amcenestrant as a monotherapy for second-line or later treatment of ER+/HER2- advanced or metastatic breast cancer. The results showed that the trial did not meet its primary endpoint: according to an independent central review assessment, compared with physician-selected single-agent endocrine therapy, amcenestrant did not improve progression-free survival (PFS).

AMEERA-3 is an open-label Phase 2 trial conducted in 367 patients with ER+/HER2- locally advanced or metastatic breast cancer who had previously received hormonal therapy. The trial evaluated the efficacy and safety of amcenestrant [an oral selective estrogen receptor degrader (SERD)] as a monotherapy and compared it with physician’s choice of single-agent endocrine therapy (including AstraZeneca's approved oral SERD, Faslodex).

Currently, Sanofi is still advancing two additional amcenestrant trials. These trials include the combination of amcenestrant with Pfizer's CDK4/6 inhibitor Ibrance for first-line treatment of ER+/HER2- metastatic breast cancer, as well as adjuvant therapy for early-stage breast cancer.

AMEERA-3 Trial Results Were Originally Expected in Q2 2021. With Continuous Delays to the Target Date, Analysts at Jefferies Have Become "Generally Skeptical" About the Prospects of Amcenestrant in Second-Line or Later-Line Treatment.

Source: Sanofi Long wait for pivotal data on Sanofi's oral SERD ends in failure