Two weeks after saying that the promising breast cancer amenestrant could be at the forefront of future treatments, Sanofi secured partners for a Phase 3 trial to study the drug versus the hormone tamoxifen.
The Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT) will initiate the pivotal trial with the French Big Pharma.
The AMEERA-6 study will examine amenestrant versus tamoxifen, a hormone therapy approved by the FDA in 1998 for women with estrogen receptor positive breast cancer who discontinued standard therapy prematurely and are susceptible to a return of the disease.
Amcenestrant, which is an oral selective estrogen receptor degrader (SERD), “has the potential to become the best-in-class oral endocrine therapy,” said Peter Adamson, MD, global head of cancer development at Sanofi, in a statement.
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Complementary therapy aims to prevent and slow the progression of the disease. Current adjuvant therapies, like aromatase inhibitors, have side effects that cause some women to stop the drugs prematurely, David Cameron, chairman of the board of BIG, said in a statement.
Sanofi will provide the funding and the investigational drug for the global study as a sponsor, while Brussels-based BIG will carry out the study within its network. The EORTC, a contracted university research organization, will handle the study, data analysis and medical management. AFT, a cancer clinical trials research organization, will handle the US portion of the study.
Two weeks ago, Sanofi presented pooled data from the amcenestrant from the phase 1 trial AMEERA-1, which achieved an objective response rate of 34% and a clinical benefit rate of 74% when it is combined with Ibrance, the Pfizer-approved breast cancer medicine.
As part of the American Society of Clinical Oncology presentation last month, Sanofi said that AMEERA-3, a potential registration study attempting to show that amenestrant is superior to physician’s choice in a setting of second intention, was delayed from the second trimester to the second half of this year.
Jefferies analysts were impressed with the early data from the AMEERA-1 program, but said the delay in AMEERA-3 “does not help build confidence in building trust in the pipeline.”
Sanofi won’t be the first in the SERD game – AstraZeneca’s Faslodex holds that title – but the French drug maker is hoping to avoid the pitfalls of the 20-year-old drug that had to be given by intramuscular injection. This painful delivery mechanism has held back sales.
Jefferies estimates that the SERD market is a $ 2-3 billion opportunity. Sanofi clashes with Roche in trying to bring a new SERD through the clinic as well as AstraZeneca, which has second-generation therapy underway.