Approval Based on Significant Overall Survival
Findings from Phase 3 KEYNOTE-048 Trial
- KEYTRUDA® is an anti-PD-1 therapy that works by helping
increase the ability of the body's immune system to help detect and
fight tumour cells.1
- The Canadian Cancer Society predicts that more than 6,550
Canadians will develop head and neck squamous cell carcinoma
(HNSCC) in 2020 and 1,900 will die from it.2
KIRKLAND, QC, Oct. 15, 2020 /CNW/ - Merck (NYSE: MRK),
known as MSD outside the United
States and Canada, today
announced that Health Canada has approved
KEYTRUDA® (pembrolizumab), Merck's anti-PD-1
therapy, for the first-line treatment of metastatic or unresectable
recurrent head and neck squamous cell carcinoma (HNSCC) as
monotherapy, in adult patients whose tumours have PD-L1 expression
[Combined Positive Score (CPS) ≥ 1] as determined by a validated
test.3 Health Canada
also approved KEYTRUDA for the first-line treatment of metastatic
or unresectable recurrent HNSCC in combination with platinum and
fluorouracil (FU) chemotherapy, in adult patients.4
"Pembrolizumab targets and fights tumour cells by helping
increase the ability of the body's immune system," said Dr.
Lillian Siu, Senior Scientist and
medical oncologist at the Princess Margaret, BMO Chair in Precision
Cancer Genomics. "This is a new treatment option that physicians
can now consider in managing patients with metastatic or recurrent
head and neck cancer."
Head and neck cancers describe different tumors that develop in
or around the throat, larynx, nose, sinuses and mouth.5
More than 90% of head and neck cancers begin in the squamous cells
that line the moist, mucosal surfaces lining the mouth, nose and
throat.6,7 The five-year relative survival rate for all
stages of HNSCC is approximately 66%8 and the Canadian
Cancer Society predicts that more than 6,550 Canadians will develop
HNSCC in 2020 and 1,900 will die from it.9
"As a survivor of head and neck cancer, I welcome new treatment
options like KEYTRUDA," said John-Peter
Bradford, HNSCC survivor. "It's significant for patients to
have a treatment option to battle with this disease."
About KEYNOTE-048 Trial
Health Canada's approval for
HNSCC is based on findings from the phase 3 study KEYNOTE-048, a
randomized, multicenter, open-label, active-controlled trial
conducted in 882 patients with metastatic or recurrent HNSCC who
had not previously received systemic therapy for recurrent or
metastatic disease and who were considered incurable by local
therapies.10 Randomization was stratified by tumor PD-L1
expression (TPS≥50% or <50%), HPV status (positive or negative),
and ECOG PS (0 vs. 1).11
The results of KEYNOTE-048 showed treatment with
KEYTRUDA® in combination with chemotherapy resulted in
a median overall survival of 13.0 months compared to 10.7 months
with standard treatment (cetuximab in combination with
chemotherapy) (HR=0.72 [95% CI, 0.60-0.87];
p=0.00025).12 In the monotherapy study arm, the median
overall survival was 12.3 months with KEYTRUDA®
compared to 10.3 months with standard treatment in the PD-L1 CPS ≥1
population (HR=0.74 [95% CI, 0.61-0.90];
p=0.00133).13
"The approval of KEYTRUDA® for the first-line
treatment of recurrent and metastatic HNSCC further reinforces
Merck's continued commitment to pursue research and development in
immuno-oncology with the ultimate goal of improving patient lives,"
says AnnA Van Acker, President,
Merck Canada. "HNSCC can have a significant negative impact on
patients, affecting a person's appearance or their ability to eat
or speak. We are proud that our work can help these patients and
provide new treatment options for the first-line management of
their disease."
About Head and Neck Cancer
Head and neck cancers can occur in the mouth (oral cavity), the
middle part of the throat near the mouth (oropharynx), the space
inside and around the nose (nasal cavity and paranasal sinuses),
the upper part of the throat near the nasal cavity (nasopharynx),
the voice box (larynx), the lower part of the throat near the
larynx (hypopharynx), or the salivary glands.14
Depending on the location, HNSCC can cause abnormal patches or open
sores (ulcers) in the mouth and throat, unusual bleeding or pain in
the mouth, sinus congestion, sore throat, earache, pain when
swallowing or difficulty swallowing, a hoarse voice, difficulty
breathing, or enlarged lymph nodes.15 The primary risk
factors associated with head and neck cancer are tobacco use and
alcohol consumption. Other risk factors include human
papillomavirus (HPV) infection (for oropharyngeal cancer), and
Epstein-Barr virus (EBV) infection (for nasopharyngeal
cancer).16
About KEYTRUDA®
KEYTRUDA® is an anti-PD-1 therapy that works by
helping increase the ability of the body's immune system to help
detect and fight tumour cells.17
KEYTRUDA® is a humanized monoclonal antibody that
blocks the interaction between PD-1 and its ligands, PD-L1 and
PD-L2, thereby activating T lymphocytes which may affect both
tumour cells and healthy cells.18
KEYTRUDA® was first approved in Canada in 2015 and currently has 16
indications in several disease areas, including advanced renal cell
carcinoma (RCC), bladder cancer, non-small cell lung carcinoma
(NSCLC), classical Hodgkin lymphoma and melanoma.19
Merck's Research Program
Merck has the industry's largest immuno-oncology clinical
research program. There are currently more than 750 trials studying
pembrolizumab across a wide variety of cancers and treatment
settings. This clinical program seeks to understand the role of
pembrolizumab across cancers and the factors that may predict a
patient's likelihood of benefitting from treatment with this
medication, including exploring several different biomarkers.
Our Focus on Cancer
Our goal is to translate progressive science into innovative
oncology medicines to help people with cancer worldwide. At Merck
Oncology, helping people fight cancer is our passion and supporting
accessibility to our cancer medicines is our commitment. Our focus
is on pursuing research in immuno-oncology and we are accelerating
every step in the journey — from lab to clinic — to potentially
bring new hope to people with cancer.
About Merck
For more than 125 years, Merck, 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 in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals — including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases — as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information about our operations in
Canada, visit www.merck.ca and
connect with us on YouTube and Twitter.
Forward-Looking Statement of Merck & Co. Inc.,
Kenilworth, NJ, 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 2017
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 the product monograph for
KEYTRUDA® (pembrolizumab) at:
https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf
References
____________________
|
1 KEYTRUDA® Product Monograph. Merck & Co.
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|
2 Canadian Cancer Society.
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Accessed on October 8, 2020.
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3 KEYTRUDA® Product Monograph. Merck & Co.
Inc. Updated October 9, 2020.
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4 KEYTRUDA® Product Monograph. Merck & Co.
Inc. Updated October 9, 2020.
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5 National Cancer Institute. What are
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https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet.
Accessed on October 8, 2020.
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6 National Institute of Health.
Molecular Pathology of Head and Neck Cancer: Implications for
Diagnosis, Prognosis, and Treatment. Available at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3703474/pdf/nihms281267.pdf.
Accessed on October 8, 2020.
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7 National Cancer Institute. What are
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Accessed on October 8, 2020.
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8 National Cancer Institute. Cancer
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Cancer-specific stats 2020 Available at
https://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics%20supplementary%20information/2020/2020_cancer-specific-stats.pdf?la=en.
Accessed on October 8, 2020.
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10 KEYTRUDA® Product Monograph. Merck & Co.
Inc. Updated October 9, 2020.
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11 KEYTRUDA® Product Monograph. Merck & Co.
Inc. Updated October 9, 2020.
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12 KEYTRUDA® Product Monograph. Merck & Co.
Inc. Updated October 9, 2020.
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13 KEYTRUDA® Product Monograph. Merck & Co.
Inc. Updated October 9, 2020.
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14 National Cancer Institute. Head
and Neck Cancers. Available at
https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet.
Accessed on October 8, 2020.
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15 Canadian Cancer Society. Symptoms
of oral cancer
https://www.cancer.ca/en/cancer-information/cancer-type/oral/signs-and-symptoms/?region=on.
Accessed on October 8, 2020.
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16 Kerstin M Stenson et al.
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at
https://www.uptodate.com/contents/epidemiology-and-risk-factors-for-head-and-neck-cancer.
Accessed on October 8, 2020.
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17 KEYTRUDA® Product Monograph. Merck & Co.
Inc. Updated October 9, 2020.
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18 KEYTRUDA® Product Monograph. Merck & Co.
Inc. Updated October 9, 2020.
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19 KEYTRUDA® Product Monograph. Merck & Co.
Inc. Updated October 9, 2020.
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SOURCE Merck