Phase 3 Study Update of Corifollitropin Alfa for Controlled Ovarian Stimulation in IVF or ICSI

Merck announced results from a Phase 3 study of corifollitropin alfa for controlled ovarian stimulation in women participating in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

In the PURSUE study, 1,390 women were evaluated in a randomized, double-blind, double-dummy, active controlled, non-inferiority trial. Participants, randomized and treated at 33 IVF centers in the United States, were selected based upon inclusion criteria which included women with an indication for controlled ovarian stimulation and IVF/ICSI, who were between the ages of 35 and 42 with a body weight of ≥50 kg (≥110 lbs) with a regular spontaneous menstrual cycle (cycle length 24–35 days). Key exclusion criteria included women with a recent history of/or current endocrine abnormality, history of/or current polycystic ovary syndrome, previous hyper-response or ovarian hyperstimulation syndrome (OHSS), previous low/no ovarian response to FSH/human menopausal gonadotropins (hMG), luteinizing hormone (LH) >12IU/L, and those who smoke or recently stopped smoking.

During the first seven days of controlled ovarian stimulation, 694 women received a single injection of 150mcg corifollitropin alfa and 696 women were treated with seven daily injections of 300IU recombinant follicle stimulating hormone (rFSH). Beginning on stimulation Day 5, women in both treatment arms received daily ganirelix acetate injections (0.25mg) (n= 692, 99.7% and n= 694, 99.7%, respectively) until the time that recombinant human chorionic gonadotropin (hCG) was administered to trigger final oocyte maturation. When required, women in both treatment arms continued treatment from stimulation Day 8 onwards with daily rFSH (maximally 300IU) until three follicles reached ≥17 mm. Three days after oocyte pick-up, two good quality embryos were to be transferred.

In the corifollitropin alfa treatment arm, the vital pregnancy rate per started cycle was comparable to that achieved in the rFSH treatment arm (n=166, 23.9% vs. n= 187, 26.9%, respectively). In line with the vital pregnancy rate, the observed ongoing pregnancy rate was 22.2% (n=154) per started cycle in the corifollitropin alfa treatment arm and 24% (n=167) per started cycle in the rFSH treatment arm. The estimated differences and 95% CIs were -3% [-7.4% to 1.4%] for the vital pregnancy rate and -1.9% [-6.1% to 2.3%] for the ongoing pregnancy rate. The mean (standard deviation) number of recovered mature oocytes per started cycle was 10.7 (7.2) and 10.3 (6.8), respectively, with a 95% CI of 0.5 (-0.2 to 1.2).

Corifollitropin alfa is a long-acting FSH agonist.

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