Sanofi has announced that one of its top pipeline therapies, a selective oestrogen receptor degrader (SERD) amcenestrant, failed to meet its primary endpoint of improving progression-free survival.
The phase 2 AMEERA-3 trial tested women aged 18 and over with hormone receptor-positive, HER2-negative advanced breast cancer. The trial was assessing the effectiveness and safety of amcenestrant – an investigational optimised oral SERD – as a monotherapy, compared to single-agent endocrine treatment for patients with ER+, HER2- locally advanced or metastatic breast cancer, with prior exposure to hormonal therapies.
Amcenestrant is an optimised oral SERD that binds to the oestrogen receptors (ER) in breast cancer cells to obstruct their normal function and generate degradation, meaning they can no longer be used by tumour cells to grow and spread.
The safety and effectiveness of amcenestrant has not been assessed by any regulatory authority and is currently under clinical investigation.
The primary aim of the breast cancer trial was to gauge if amcenestrant improved progression-free survival compared to endocrine monotherapy.
While results from the clinical trial showed that it did not meet its primary endpoint, Sanofi plans to continue its assessment of data from the AMEERA-3 trial, working with investigators on the publication of the results.
The ongoing clinical programme for amcenestrant will go ahead as scheduled, including AMEERA-5 and AMEERA-6.
Speaking on the outcomes of the trial, John Reed, head of Research and Development at Sanofi, said: “This phase 2 trial evaluated amcenestrant as a monotherapy in a patient population with advanced disease where limited treatment options remain.
“While we are disappointed with the AMEERA-3 results, we continue to investigate amcenestrant in patients with earlier stages of breast cancer with different tumour profiles and where different standard of care treatments are used.”