Merck’s 20-year commitment to HPV research
highlighted in oral session
Merck (NYSE:MRK), known as MSD outside of the United States and
Canada, announced results from final analyses of the pivotal Phase
III efficacy, immunogenicity, and safety clinical trial for
GARDASIL® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant).
The data, which showed sustained efficacy for up to six years in
the per protocol population, were presented during an oral session
at the European Research Organization on Genital Infection and
Neoplasia (EUROGIN) congress in Amsterdam, Netherlands.
GARDASIL 9 is a vaccine indicated for use in girls and women 9
through 26 years of age for the prevention of cervical, vulvar,
vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45,
52, and 58; pre-cancerous or dysplastic lesions caused by HPV types
6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by
HPV types 6 and 11. GARDASIL 9 is also indicated for use in boys
and men 9 through 26 years of age for the prevention of anal cancer
caused by HPV types 16, 18, 31, 33, 45, 52, and 58; precancerous or
dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45,
52, and 58; and genital warts caused by HPV types 6 and 11.
GARDASIL 9 is contraindicated in individuals with hypersensitivity,
including severe allergic reactions to yeast, or after a previous
dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent
(types 6, 11, 16, and 18) Vaccine, Recombinant].
These final analyses evaluated study outcomes, including
efficacy for up to six years following receipt of first vaccine
dose, and antibody responses over five years. Vaccination impact on
cervical cytology abnormalities and related therapeutic procedures
were also reported. These final analyses are from the base study; a
study extension is ongoing to evaluate long term follow-up for an
additional 10 years following the end of the base study.
In these analyses at six years, efficacy for GARDASIL 9 against
HPV31/33/45/52/58-related cervical pre-cancers (cervical
intraepithelial neoplasia Grade 3 (CIN 3) was 100 percent (95% CI:
39·4, 100) in the per-protocol population. Efficacy against HPV
type 31/33/45/52/58-related cervical, vulvar, and vaginal disease,
persistent infection, cervical cytological abnormalities; cervical
biopsy; and cervical definitive therapy ranged from 90-98 percent.
Incidence of HPV6/11/16/18-related persistent infection, disease,
cytological abnormalities, and procedures was similar in recipients
of GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
and GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16
and 18) Vaccine, Recombinant].
GARDASIL 9 produced similar antibody protection against the four
HPV types in GARDASIL. Antibodies to the HPV types targeted by
GARDASIL 9 persisted through five years following vaccination.
Geometric mean titer ratios (GARDASIL 9/GARDASIL) for HPV6/11/16/18
varied minimally over time. The two vaccines had similar adverse
event profiles; injection-site adverse events were more common with
GARDASIL 9; most were mild-to-moderate in intensity. A paper
detailing these results was also published online on September 5 in
The Lancet.
“These new analyses show that efficacy of GARDASIL 9 in
preventing certain HPV-related cancers and diseases was sustained
for up to six years,” said Elmar A. Joura, M.D., Associate
Professor of Gynecology and Obstetrics at the Medical University of
Vienna, General Hospital (AKH), and Comprehensive Cancer Center
Vienna, Austria, who presented these data at EUROGIN. “Despite the
progress we’ve made with HPV vaccination over the past 11 years,
HPV-related cancers and diseases are still a significant public
health issue and continued efforts are needed to increase uptake of
the vaccine.”
About the study
The clinical trial program for GARDASIL 9 was designed to build
upon the efficacy established in clinical trials with GARDASIL. In
this Phase III active comparator-controlled, double-blind,
randomized clinical trial (Protocol 001), 14,215 females 16-26
years of age were randomized to receive a three-dose series of
GARDASIL 9 (n=7,106) or GARDASIL (n=7,109). The primary comparison
between GARDASIL 9 and GARDASIL was clinical efficacy for the five
additional HPV types. Efficacy of GARDASIL 9 against persistent
infection and disease related to the original four HPV types (6,
11, 16, or 18) was inferred based on immunogenicity comparisons.
The primary efficacy analysis was conducted in those who received
all three doses of vaccine within one year of enrollment, did not
have deviations from the study protocol that could affect the
evaluation of vaccine efficacy, were negative (PCR negative and
seronegative) to the relevant HPV type(s) prior to dose 1, and who
remained PCR negative to the relevant HPV type(s) through Month 7
(per-protocol efficacy, or PPE, population).
The primary efficacy evaluation was based on a composite
clinical endpoint of HPV 31-, 33-, 45-, 52-, and 58-related
cervical, vulvar, and vaginal cancer, and high-grade
cervical/vulvar/vaginal disease [CIN 2/3 (cervical intraepithelial
neoplasia 2/3) or AIS (adenocarcinoma in situ), VIN 2/3 (vulvar
intraepithelial neoplasia 2/3), and VaIN 2/3 (vaginal
intraepithelial neoplasia 2/3)]. Additional secondary endpoints
related to HPV 31, 33, 45, 52, and 58 were also evaluated. Efficacy
for all endpoints was measured starting after the Month 7
visit.
Efficacy of GARDASIL 9 against persistent infection and disease
related to HPV types 6, 11, 16, or 18 was inferred from
non-inferiority comparisons of geometric mean titers (GMTs) in 16-
through 26-year-old girls and women following vaccination with
GARDASIL 9 with those following vaccination with GARDASIL [Human
Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine,
Recombinant]. Antibody responses for HPV 6, 11, 16, and 18
(measured by GMTs and seroconversion rates at Month 7) for GARDASIL
9 among young women 16 to 26 years of age were non-inferior to
those who received GARDASIL.
Important Information about GARDASIL 9 (Human Papillomavirus
9-valent Vaccine, Recombinant)
GARDASIL 9 does not eliminate the necessity for women to
continue to undergo recommended cervical cancer screening.
Recipients of GARDASIL 9 should not discontinue anal cancer
screening if it has been recommended by a health care
professional.
GARDASIL 9 has not been demonstrated to provide protection
against diseases from vaccine HPV types to which a person has
previously been exposed through sexual activity.
GARDASIL 9 is not a treatment for external genital lesions;
cervical, vulvar, vaginal, and anal cancers; or CIN; VIN; VaIN; or
AIN.
Not all vulvar, vaginal, and anal cancers are caused by HPV, and
GARDASIL 9 protects only against those vulvar, vaginal, and anal
cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58.
Vaccination with GARDASIL 9 may not result in protection in all
vaccine recipients.
Select Safety Information for GARDASIL 9
GARDASIL 9 is contraindicated in individuals with
hypersensitivity, including severe allergic reactions to yeast, or
after a previous dose of GARDASIL 9 or GARDASIL.
Because vaccinees may develop syncope, sometimes resulting in
falling with injury, observation for 15 minutes after
administration is recommended. Syncope, sometimes associated with
tonic-clonic movements and other seizure-like activity, has been
reported following HPV vaccination. When syncope is associated with
tonic-clonic movements, the activity is usually transient and
typically responds to restoring cerebral perfusion.
Safety and effectiveness of GARDASIL 9 have not been established
in pregnant women.
The most common (≥10%) local and systemic adverse reactions in
females were injection-site pain, swelling, erythema, and headache.
The most common (≥10%) local and systemic reactions in males were
injection-site pain, swelling, and erythema.
The duration of immunity with GARDASIL 9 has not been
established.
About GARDASIL® 9 (Human Papillomavirus
9-valent Vaccine, Recombinant)
GARDASIL 9 includes the greatest number of HPV types in any
available HPV vaccine. After HPV types 16 and 18, the five
additional HPV types in GARDASIL 9 are the most common cervical
cancer-causing types worldwide. Seven HPV types in GARDASIL 9 (HPV
16, 18, 31, 33, 45, 52 and 58) cause approximately 90 percent of
cervical cancer cases and approximately 80 percent of high-grade
cervical lesions (cervical precancers, defined as CIN 2, CIN 3 and
AIS) worldwide. These seven HPV types also cause 85-90 percent of
HPV-related vulvar cancers, 80-85 percent of HPV-related vaginal
cancers, and 90-95 percent of HPV-related anal cancers. HPV types 6
and 11 cause approximately 90 percent of genital warts cases. In
addition, approximately 50 percent of cases of low-grade cervical
lesions (CIN 1) are caused by the nine HPV types included in the
vaccine.
GARDASIL 9 is approved for use in more than 60 countries, and
since 2015 more than 26 million doses have been distributed
worldwide, although the exact number of doses that have been
administered is unknown. GARDASIL [Human Papillomavirus
Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] is no
longer available in the United States.
Dosage and administration for GARDASIL 9
GARDASIL 9 should be administered intramuscularly in the deltoid
region of the upper arm or in the higher anterolateral area of the
thigh.
- For individuals 9 through 14 years of
age, GARDASIL 9 can be administered using a2-dose or 3-dose
schedule. For the 2-dose schedule, the second dose should be
administered 6-12 months after the first dose. If the second dose
is administered less than 5 months after the first dose, a third
dose should be given at least 4 months after the second dose. For
the 3-dose schedule, GARDASIL 9 should be administered at 0, 2
months, and 6 months.
- For individuals 15 through 26 years of
age, GARDASIL 9 is administered using a3-dose schedule at 0, 2
months, and 6 months.
20-year commitment to HPV vaccine research
Prof. Anna Giuliano of Moffitt Cancer Center in Tampa, Fla.
presented a review of Merck’s 20-year history of HPV vaccine
research during an oral session at EUROGIN. Merck’s
proof-of-principle studies with monovalent HPV vaccines in 1997
were followed in 2000 with the start of clinical studies for the
quadrivalent HPV vaccine, GARDASIL [Human Papillomavirus
Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. First
regulatory approvals of GARDASIL were received in 2006. Studies
have continued to evaluate duration of protection as well as
safety.
HPV types 16 and 18 cause approximately 70 percent of cervical
cancer cases. In 2004, HPV types 31, 33, 45, 52, and 58 were
classified as the next most frequent HPV types associated with
cervical cancer, causing an additional 20 percent of cases. Merck
started a Phase II study in 2005 to evaluate a HPV vaccine
candidate that could protect against more HPV types. Ultimately
this led to the development of the 9-valent HPV vaccine, GARDASIL 9
(Human Papillomavirus 9-valent Vaccine, Recombinant), which helps
to protect against certain cancers and diseases caused by these
five HPV types in addition to the four original HPV types covered
by GARDASIL. Phase III clinical studies for GARDASIL 9, which
evaluated more than 20,000 individuals who received the vaccine,
began in 2007, just one year after GARDASIL was licensed.
“Merck has had a sustained and unwavering commitment to HPV
vaccine research for 20 years,” said Eliav Barr, MD, senior vice
president, Global Clinical Development – Infectious Disease &
Vaccines, Merck Research Laboratories. “With HPV vaccination,
screening, treatment, and education, it is our aspiration that one
day the number of women and men affected by HPV-related cancers and
diseases will be significantly reduced. There is obviously much
work ahead of us, but we look forward to continuing our efforts in
collaboration with the many stakeholders around the world who share
our commitment.”
About HPV and related cancers and diseases
In the United States, human papillomavirus (HPV) will infect
most sexually active males and females in their lifetime. According
to the CDC, there are approximately 14 million new genital HPV
infections in the United States each year, half of which occur in
people 15 through 24 years of age. For most people, HPV clears on
its own, but for others who don't clear the virus it could lead to
certain cancers and other diseases in males as well as females.
There is no way to predict who will or won’t clear the virus.
HPV causes virtually all cervical cancer cases. Each day, about
35 women are diagnosed with cervical cancer in the United States --
about 12,900 women per year. HPV also causes approximately 70-75
percent of vaginal cancer cases and approximately 30 percent of
vulvar cancer cases in females, and approximately 85-90 percent of
anal cancers and 90 percent of genital warts in both females and
males. Additionally, there are an estimated 3 million abnormal Pap
results, many of which are caused by HPV, that require follow-up
each year in the United States.
Anal cancer and genital warts affect both men and women.
According to the American Cancer Society, an estimated 2,920 men
and 5,160 women in the United States will be diagnosed with anal
cancer in 2016, and overall rates have been increasing. There is no
routine screening recommended for the general population to reduce
the risk of anal cancer. Approximately 355,000 cases of genital
warts occur each year in the United States. Treatment of genital
warts can be painful, and they may recur after treatment,
especially in the first three months. Approximately 3 out of 4
people get them after having genital contact with someone who has
genital warts.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world's most challenging diseases.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer's disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us on Twitter, Facebook,
Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2016
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for GARDASIL®
9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf
and Patient Product Information for GARDASIL® 9
at
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf.
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MerckMedia Contacts:Pamela Eisele, 267-305-3558Deb Wambold,
267-305-0642orInvestor Contacts:Teri Loxam, 908-740-1986Michael
DeCarbo, 908-740-1807
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