Sanofi has officially dropped out of the race to develop a breast cancer drug in pill form that could compete with blockbuster injectable therapies.The pharma giant’s competitor amcenestrant has Failure A disappointing result in a pivotal study also meant the end of all clinical trials testing the drug.
The decision announced Wednesday follows an interim study of data from the Phase 3 clinical trial. Sanofi said the results did not meet pre-set criteria for continuing the trial, and an independent data monitoring committee recommended stopping the trial. Sanofi said no new safety signals were reported in the interim results.
Sanofi is developing amcenestrant for the treatment of patients with estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer. The small molecule is part of a class of drugs called selective estrogen receptor degraders (SERDs). These drugs are designed to degrade ER receptors that are key drivers of cancer cell growth. The only FDA-approved SERD is AstraZeneca’s fulvestrant. The drug validates ER degradation as a treatment for cancer, but it is administered as a painful intramuscular injection and has side effects. Large pharmaceutical companies and emerging biotech companies have been working hard to develop oral SERDs that could offer better safety and efficacy.
A Phase 3 study of amcenestrant is evaluating the drug as a first-line cancer treatment. The drug was tested in combination with Pfizer’s Ibrance, the standard treatment for ER-positive/HER2-negative breast cancer. The pairing was compared to treatments with letrozole, an older hormone-based cancer treatment, and Ibrance.
Phase 3 failure of Sanofi drug comes in Phase 2 misses The company tested the drug alone as a second-line treatment for advanced ER-positive/HER2-negative breast cancer. In March, Sanofi reported that the interim study failed to meet its primary goal of improving progression-free survival, a measure of how long patients survive without their cancer getting worse. Amcenestrant is also being tested in a separate Phase 3 study as an adjuvant, a therapy used to prevent the recurrence of treated cancers. Sanofi said the latest trial failure meant the ancillary study would also come to an end.
Other companies have encountered setbacks in their verbal SERD efforts. In April, Roche reports that its drug giredestrant misses key goal of improving progression-free survival In patients with advanced ER-positive/HER2-negative breast cancer, despite early treatment progression. According to the Swiss pharma giant’s first-half 2022 financial report, the Phase 2 program has been removed from the pipeline, but Phase 3 testing of the drug as a first-line and adjunctive treatment is underway.
As Sanofi exits development of amcenestrant, partners Menarini Group and Radius Health are the frontrunners to commercialize the first oral SERD.these companies report Last fall, their drug elacestrant met its primary goal of phase 3 testing.them submit A new drug application was filed with the FDA in June.
Sanofi said it will continue to review data from its failed amcenestrant study and announce results at a future date. Patients receiving amcenestrant will be switched to letrozole in combination with Ibrance or other standard of care as determined by their physician.
“While we are disappointed by this result, our study will further the scientific understanding of endocrine therapy in breast cancer patients,” John Reed, global head of research and development at Sanofi, said in a prepared statement. “We sincerely thank the patients, families and healthcare professionals who have participated in the clinical development program of amcenestrant. Oncology remains a priority area for Sanofi and we will continue our transformative research to develop new medicines for cancer patients.”
Public area picture by the National Cancer Institute
