Sanofi: amcenestrant trial failed to meet primary endpoint


PARIS (Agefi-Dow Jones)–The pharmaceutical group Sanofi announced on Monday that the AMEERA-3 phase 2 trial evaluating amcenestrant in the treatment of advanced or metastatic breast cancer had not met its endpoint. primary, namely the improvement of patient survival without progression of the disease.

“No new safety signals were identified and the safety profile of amcenestrant in the AMEERA-3 trial was consistent with that observed in previous studies,” Sanofi said in a statement.

The group has also indicated that it will continue to evaluate the data from the AMEERA-3 trial and collaborate with the investigators with a view to the publication of its complete results.

“The ongoing clinical trial program for amcenestrant continues as planned, including the AMEERA-5 and AMEERA-6 trials,” Sanofi added.

This program was designed by Sanofi to assess the potential of amcenestrant as an oral disease-modifying endocrine therapy in different settings and, in particular, in combination with palbociclib for the first-line treatment of metastatic breast cancer (AMEERA- 5), as well as to assess its potential in the treatment of early-stage breast cancer in an adjuvant setting (AMEERA-6).

Enrollment in the AMEERA-5 Phase 3 clinical trial, launched in late 2020, is complete, while enrollment in the AMEERA-6 Phase 3 trial is ongoing.

-Dimitri Delmond, Agefi-Dow Jones; +33 (0)1 41 27 47 31; [email protected] ed: JXM

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March 14, 2022 02:27 ET (06:27 GMT)



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