Schering-Plough Announces Phase II and III Data for Corifollit...(Further sub-analyses of the ENGAGE trial...)

Date:7/1/2009

Further sub-analyses of the ENGAGE trial showed a single injection of 150 mcg corifollitropin alfa, compared to the daily rFSH treatment arm, achieved consistently high pregnancy outcomes regardless of fertilization procedure (in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), number of embryos transferred (single or double), or day of embryo transfer (day three or five), confirming the robustness of the main efficacy outcome.(1)

An additional sub-analysis of the ENGAGE data demonstrated that endogenous luteinizing hormone (LH) levels do not affect ongoing pregnancy rates in women undergoing controlled ovarian stimulation (COS) with a standardized rFSH / gonadotropin-releasing hormone (GnRH) antagonist protocol.(3)

An analysis compared data from the ENGAGE trial to data from the ENSURE trial. The ENSURE trial used a similar protocol to ENGAGE with identical patient inclusion criteria but different body weight categories. It showed that exposure and ovarian response were similar after a single-dose of 100 mcg corifollitropin alfa in patients weighing 60 kg or less, as compared to 150 mcg corifollitropin alfa in patients weighing more than 60 kg.(4) Additional data from the ENSURE trial show that in patients weighing 60 kg or less, a single dose of 100 mcg corifollitropin alfa resulted in significantly more oocytes and an equally short duration of treatment as those receiving 150 IU rFSH daily during the first week of stimulation.(5)

Data was also presented from the Phase II REALIZE study, a 50 patient, open-label uncontrolled pilot study. In this study, a single dose of 100 mcg or 150 mcg corifollitropin alfa in a long GnRH agonist protocol was able to support multifollicular development during the first week of ovarian stimulation.(6)

About ENGAGE

ENGAGE was a non-inferiority trial designed to compare corifollitropin alfa 150 mcg to 200 IU rFSH (f
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