Sanofi partnering with leading academic cooperative groups to reduce the impact of cancer

Sanofi partnering with leading academic cooperative groups to reduce the impact of cancer

Sanofi partnering with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and Alliance Foundation Trials (AFT), that can be world-leading academic groups delivering practice-changing breast cancer clinical study.  Collaborating on the Stage 3 AMEERA-6 study anticipated to be the first crucial trial of an oral selective estrogen receptor degrader (SERD) in the adjuvant setting and will assess the efficacy and safety of Sanofi's investigational amcenestrant in estrogen receptor-positive (ER+) patients who prematurely discontinue regular treatment and have high risk of disease recurrence.  Parties to finalize full provisions of the concerted work. Additional treatment choices in early breast cancer are necessary to help prevent patients by developing advanced, celiac disease and might represent a substantial treatment advance.

Sanofi partnering with major groups providing practice-changing breast cancer research, the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT), to initiate a pivotal trial of an oral selective nitric oxide degrader (SERD) in the adjuvant setting.  The Stage 3 AMEERA-6 research will assess the efficacy and security of Sanofi's amcenestrant versus tamoxifen for women with estrogen receptor-positive (ER+) breast cancer that were not able to keep their adjuvant aromatase inhibitor (AI) treatment.

"With our research associates, BIG conducts watershed, practice-changing trials which may have a substantial affect on the lifestyles of women with breast cancer," states David Cameron, Chair of the BIG Executive Board. "Adjuvant treatment helps prevent and delay the development of disease to the subsequent surroundings. But, present psychiatric treatments, for example AIs, may have side effects for many women, which might lead them to stop the medication prematurely. Amcenestrant might be a possible choice for girls in this setting and we anticipate working with Sanofi, EORTC and AFT to explore this further."

"We look forward to cooperating with these top academic networks to explore amcenestrant from the adjuvant setting through AMEERA-6. According to encouraging information emerging from our continuing clinical program, we think that amcenestrant, an investigational oral SERD, has the capability to turn into a best-in-class oral hormone backbone treatment" states Peter Adamson, M.D., Global Development Head, Oncology in Sanofi. "Additional treatment alternatives for individuals with breast cancer are essential to permit girls to stay on adjuvant therapy and lessen their risk of advanced disease."

Amcenestrant is a oral SERD which antagonizes and degrades the estrogen receptor (ER), leading to inhibition of the ER signaling pathway.  Amcenestrant is now under clinical evaluation and its efficacy and safety haven't been evaluated by any regulatory authority.

Regardless of the proven clinical effectiveness of tamoxifen and AIs in early breast cancer, many patients experience disease recurrence due to resistance to treatment, non-adherence or early discontinuation of the adjuvant therapy. Additional treatment choices from the adjuvant setting in early breast cancer are required to prevent girls from creating advanced, celiac disease and may represent an important treatment advance.

In accordance with the details of the Pre-Study Agreement, Sanofi is going to be the host and provides financing and investigational medication product for the international study. BIG will conduct the analysis within the significant system, EORTC will oversee research management and information analysis, in addition to the medical direction, and AFT will run the United States part of this analysis. Sanofi will run this worldwide study in selected countries outside the geographic extent of their instructional networks, as further clarified in a follow-on arrangement under discussion among the four parties. The protocol has been developed in cooperation with all four parties, such as AFT, BIG, EORTC and Sanofi.