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Merck's Investigational Vaccine GARDASILâ„¢ Prevented 100 Percent of Cervical
Pre-cancers and Non-invasive Cervical Cancers Associated with HPV Types 16 and
18 in New Clinical Study
Phase III Study will be Presented for the First Time at IDSA
WHITEHOUSE STATION, N.J., Oct. 6, 2005 - GARDASILTM (quadrivalent human
papillomavirus types 6, 11, 16, 18, recombinant vaccine), an investigational
vaccine from Merck & Co., Inc., prevented 100 percent of high-grade cervical
pre-cancers and non-invasive cervical cancers (CIN 2/3 and AIS) associated with
human papillomavirus (HPV) types 16 and 18 in a new phase III study. The
analysis compared GARDASIL to placebo in women who were not infected with HPV 16
and 18 at enrollment and who remained free of infection through the completion
of the vaccination regimen. Women were followed for an average of two years
after enrollment. Tomorrow these data will be presented for the first time at
the Infectious Diseases Society of America (IDSA) annual meeting.
This trial is part of the ongoing phase III program for GARDASIL, which involves
over 25,000 people in 33 countries worldwide. Merck remains on track to submit
a Biologics License Application for GARDASIL to the Food and Drug Administration
in the fourth quarter of 2005.
More than 12,000 women from 13 countries participated in this trial
This phase III study, titled FUTURE II, is a prospective, randomized,
double-blind, placebo-controlled study with two vaccination groups. Women aged
16 to 26 years were randomized to receive a three-dose regimen of either
GARDASIL or placebo at Day 1, Month 2, and Month 6. A total of 12,167 women
were enrolled from 90 study centers in Brazil, Colombia, Denmark, Finland,
Iceland, Mexico, Norway, Peru, Poland, Singapore, Sweden, the United Kingdom and
the United States (including Puerto Rico) and were equally allocated between the
two groups. A group of 6,082 females received GARDASIL and another group of
6,075 received placebo.
FUTURE II evaluated the incidence of HPV 16/18-related cervical pre-cancers
known as CIN (cervical intraepithelial neoplasia) 2/3 and non-invasive cancers.
CIN 2 is a moderate-grade lesion of the cervix. CIN 3 represents both
high-grade lesions and CIS (carcinoma in situ), the immediate pre-cursor to
invasive squamous cell cervical cancer. AIS (adenocarcinoma in situ) is the
early development of adenocarcinoma (or glandular cancer) of the cervix. CIN 3
and AIS are defined as Stage 0 cancer according to the International Federation
of Gynecology and Obstetrics (FIGO) classification.
The primary analysis of this trial evaluated the incidence of CIN 2/3 and AIS in
women who received three doses of GARDASIL, had no major protocol violations and
remained free of HPV 16 and/or HPV 18 infection through month 7; this analysis
started 30 days after completion of the vaccination regimen, and followed women
for an average of 17 months after completion of the regimen. In this group,
GARDASIL prevented 100 percent of cases of high-grade pre-cancer and
non-invasive cancer (CIN 2/3 or AIS) associated with HPV types 16 and 18 (p <
0.001); no cases of CIN 2/3 or AIS were observed in the vaccine group (n=5,301)
compared to 21 cases in the placebo group (n= 5,258).
"These are the first pivotal data to show that vaccination with GARDASIL reduced
HPV 16 and18-related cervical pre-cancer and non-invasive cervical cancer," said
Laura Koutsky, Ph.D., principal investigator, HPV research group, University of
Washington, Seattle.
A secondary analysis, also being presented, evaluated the incidence of CIN 2/3
and AIS in a broader group of women. This analysis started 30 days after
administration of the first dose of GARDASIL or placebo, and included all of the
women in the primary analysis group, as well as women who may have become
infected with HPV 16 or HPV 18 during the vaccination period and women who may
have violated the protocol in significant ways (for example, by missing certain
protocol visits). On average, these women were followed for approximately two
years. In this group, GARDASIL reduced the risk of developing high-grade
pre-cancer and non-invasive cancer (CIN 2/CIN 3, or AIS) associated with HPV
types 16 and 18 by 97 percent (n= 5,736); one case was observed in the vaccine
group compared to 36 in the placebo group (n= 5,766).
There were no discontinuations due to serious vaccine-related adverse events.
Adverse events were higher among those who received GARDASIL compared with
placebo recipients. The most common vaccine-related adverse event reported was
local discomfort at the injection site.
"Merck has been committed to vaccine research and development for over a
century," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We
have hope that GARDASIL will continue the great Merck tradition of developing
medicines and vaccines that make a real difference in people's lives."
GARDASIL was designed to target HPV types 16 and 18, which account for 70
percent of cervical cancers, and HPV types 6 and 11, which account for 90
percent of cases of genital warts. These four types also cause benign cervical
changes that result in "abnormal" Pap tests.
GARDASIL is one of three late-stage vaccines in development at Merck. In April,
Merck submitted Biologics License Applications to the FDA for ROTATEQ, a vaccine
for rotavirus gastroenteritis, and ZOSTAVAX, a vaccine for shingles.
Approximately 20 million American men and women are infected with HPV
HPV has been identified as the cause of cervical cancer, pre-cancers, benign
cervical lesions and genital warts. Cervical cancer, one of the leading cancers
among women, results in approximately 290,000 deaths worldwide each year. In
the United States an estimated 10,400 new cases of cervical cancer will be
diagnosed in 2005, and there will be an estimated 3,700 deaths from cervical
cancer. It is estimated that approximately 20 million men and women in the
United States are infected with HPV. In most people, HPV goes away on its own.
In some, however, certain high-risk or oncogenic types of HPV can lead to
cervical cancer. The virus is also associated with abnormal Pap tests and
genital warts. Each year, about one million women in the United States are told
they have "an abnormal Pap" - which may trigger additional testing, anxiety, and
in some cases fears of cancer.
In 1995, Merck entered into a license agreement and collaboration with CSL
Limited relating to technology used in GARDASIL. GARDASIL is also the subject
of other third-party licensing agreements.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated
to putting patients first. Established in 1891, Merck discovers, develops,
manufactures and markets vaccines and medicines in more than 20 therapeutic
categories. The company devotes extensive efforts to increase access to
medicines through far-reaching programs that not only donate Merck medicines but
help deliver them to the people who need them. Merck also publishes unbiased
health information as a not-for-profit service. For more information, visit
www.merck.com.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined
in the Private Securities Litigation Reform Act of 1995. These statements
involve risks and uncertainties, which may cause results to differ materially
from those set forth in the statements. The forward-looking statements may
include statements regarding product development, product potential or financial
performance. No forward-looking statement can be guaranteed, and actual results
may differ materially from those projected. Merck undertakes no obligation to
publicly update any forward-looking statement, whether as a result of new
information, future events, or otherwise. Forward-looking statements in this
press release should be evaluated together with the many uncertainties that
affect Merck's business, particularly those mentioned in the cautionary
statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2004, and
in its periodic reports on Form 10-Q and Form 8-K, which the company
incorporates by reference.
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