Merck Announces Results From New Phase III Study Amongst Women for Corifollitropin Alfa, an Investigational Fertility Treatment for Controlled Ovarian Stimulation


October 23, 2012 1:15 pm ET

New Phase III Study Presented at the Annual Meeting of the American Society for Reproductive Medicine

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced results from the PURSUE Phase III study of 1,390 women,
aged 35-42 years, for corifollitropin alfa, the company’s
investigational fertility treatment for controlled ovarian stimulation
in women participating in vitro fertilization (IVF) or intracytoplasmic
sperm injection (ICSI). The study met its primary endpoint of achieving
vital pregnancy rates with data revealing that a single injection of 150
mcg of corifollitropin alfa was non-inferior to seven daily injections
of 300 IU recombinant follicle stimulating hormone (rFSH). The study
also evaluated key secondary endpoints of ongoing pregnancy rates and
the number of oocytes (the female reproductive cell prior to
fertilization) retrieved. Merck presented the results today at the 68th
Annual Meeting of the American Society for Reproductive Medicine.

Merck remains on track to file a New Drug Application (NDA) for
corifollitropin alfa with the U.S. Food and Drug Administration (FDA) in

“Infertility is an issue many couples in the U.S. face,” said Robert
Boostanfar, M.D., study author, reproductive endocrinologist at HRC
Fertility and clinical assistant professor at the Keck School of
Medicine, Department of Obstetrics and Gynecology, University of
Southern California. “If approved, corifollitropin alfa may provide
clinicians with a different option for women undergoing controlled
ovarian stimulation prior to IVF and ICSI.”

Study Design

In the PURSUE trial, 1,390 women in the United States, aged 35-42 years,
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) > 12.0 IU/L, and those who smoke or recently
stopped smoking.

The primary efficacy endpoint assessed the vital pregnancy rate, defined
as the presence of at least one fetus with heart activity at least 35
days or more after embryo transfer. The predefined non-inferiority
margin was -8 percent. Secondary efficacy endpoints assessed the ongoing
pregnancy rates (continued heart activity at least 10 weeks after embryo
transfer, or live birth), and the number of oocytes retrieved. Other
endpoints included a safety evaluation.

During the first seven days of controlled ovarian stimulation, 694 women
received a single injection of 150 mcg corifollitropin alfa and 696
women were treated with seven daily injections of 300 IU rFSH. The mean
age (standard deviation) for both treatment arms was 38.0 (2.2) years,
and body weight (standard deviation) for the corifollitropin alfa and
rFSH treatment arms were 67.8 kg (10.7) and 66.6 kg (10.8),
respectively. Beginning on stimulation day 5, women in both treatment
arms received daily ganirelix acetate injections (0.25 mg) (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 300
IU) until three follicles reached ≥ 17 mm. Three days after oocyte
pick-up, two good quality embryos were to be transferred.

Efficacy Results

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 percent
(n=154) per started cycle in the corifollitropin alfa treatment arm and
24.0 percent (n=167) per started cycle in the rFSH treatment arm. The
estimated differences and 95 percent confidence intervals were -3.0
percent [-7.4 to 1.4] for the vital pregnancy rate and -1.9 percent
[-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 percent confidence
interval of 0.5 (-0.2 to 1.2).

Safety Profile

The overall rate of drug-related adverse events was 20.5 percent for
woman receiving corifollitropin alfa and 18.5 percent for woman
receiving rFSH. The overall incidence of serious adverse events (>1.0%)
in the corifollitropin alfa and rFSH treatment arms were 0.4 percent
versus 2.6 percent, respectively. Treatment discontinuations due to
adverse events (AEs) were 0.7 percent for women receiving
corifollitropin alfa versus 0.9 percent for women receiving rFSH. The
drug-related incidence of ovarian hyperstimulation syndrome (OHSS) in
the corifollitropin alfa and rFSH treatment arms were 1.7 percent versus
1.4 percent. The number of reported incidences of OHSS in the
corifollitropin alfa and rFSH groups that required hospitalization were
0.0 percent versus 0.3 percent, reported as a SAE were 0.0 percent
versus 0.7 percent, or graded II (moderate) and/or III (severe) were 0.7
percent versus 1.4 percent, respectively. The most common drug-related
AEs (>1.0%) in women receiving corifollitropin alfa and rFSH,
respectively, included headache (6.1% vs. 5.6%), pelvic discomfort (5.8%
vs. 5.9%), nausea (3.9% vs. 2.4%), breast tenderness (2.6% vs. 1.1%),
fatigue (1.9% vs. 2.0%), pelvic pain (1.6% vs. 1.6%), injection site
pain (1.2% vs. 0.6%), and dizziness (0.6% vs. 1.1%).

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Pam Eisele, 908-423-5042
Tina Grasso, 267-893-9783
Carol Ferguson, 908-423-4465

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