Ferring Pharmaceuticals announced today a new analysis of data from the Phase 3 ESTHER-1 trial showing that natural variations in anti-Müllerian hormone (AMH) levels during and between a woman's menstrual cycle have no clinically relevant impact on ovarian response (the number of eggs produced) when using AMH to dose Rekovelle® (follitropin delta) for ovarian stimulation (OS). The data were presented today at the 34th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Barcelona, Spain.
According to the new analysis, for 95% of women treated with Rekovelle, variations in ovarian response were limited to a difference of plus or minus one egg. This reinforces that AMH measured on any day of a woman's menstrual cycle can be used to individualize the dose of Rekovelle. AMH is measured with a companion diagnostic, the Elecsys® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).
"We are excited to share the results of this new Rekovelle analysis which add to existing evidence showing AMH is a robust predictor of ovarian response to fertility treatment," said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. "I believe these data will further strengthen the growing confidence of doctors in the use of AMH to personalize dosing of fertility treatment for their patients."
Ovarian response to stimulation varies considerably from woman to woman and unexpected extreme responses have implications on efficacy and safety. Aiming to avoid extremes in ovarian response, the validated Rekovelle dosing algorithm uses AMH and body weight to determine a personalized dose for patients, from the start of treatment.
This analysis of data from the Phase 3 ESTHER-1 trial adds to consistent efficacy results seen with Rekovelle in clinical trials to date. The ESTHER-1 trial showed that women undergoing their first treatment cycle receiving individualized treatment with Rekovelle, compared to conventional dosing regimen with follitropin alfa, had similar ongoing pregnancy and embryo implantation rates.
The ESTHER-1 trial also showed that more women receiving individualized treatment with Rekovelle achieved the target response of 8-14 eggs compared to conventional dosing regimen with follitropin alfa. Evidence shows that beyond 15 eggs there is no additional benefit, in terms of live birth rate, in the number of eggs produced through OS in a fresh cycle.