KEYTRUDA®
(pembrolizumab) in Combination with Pemetrexed and
Platinum Chemotherapy Reduced the Risk of Death by Half Compared to
Chemotherapy Alone
- Every day, approximately 78 Canadians are diagnosed with lung
cancer and 58 die from iti
- Non-small cell lung cancer (NSCLC) is the most common form of
lung cancer, making up 80 to 85 per cent of all
casesii
- The five-year survival rate for advanced NSCLC is currently
estimated to be 2 to 13 per centiii
KIRKLAND, QC, March 18, 2019 /CNW/ - Merck (NYSE: MRK), known
as MSD outside the United States
and Canada, today announced that
Health Canada has expanded the label for KEYTRUDA®
(pembrolizumab), Merck's anti-PD-1 therapy, to include
approval for the treatment of metastatic non-squamous NSCLC, in
combination with pemetrexed and platinum chemotherapy, in adults
with no EGFR or ALK genomic tumour aberrations, and no prior
systemic chemotherapy treatment for metastatic NSCLC.
"Lung cancer is the deadliest form of cancer in Canada. It is vital that we continue to
develop new approaches to treating this, sadly, too common
disease," said Dr. Normand Blais,
medical oncologist at the Centre Hospitalier Universitaire de
Montréal. "Immuno-oncology therapies are changing the way we treat
lung cancer in Canada and helping
to change survival expectations for these patients."
In the pivotal, Phase 3 KEYNOTE-189 trial of patients regardless
of PD-L1 tumour expression status, KEYTRUDA®, in
combination with pemetrexed and platinum chemotherapy, demonstrated
a statistically significant and clinically meaningful improvement
in overall survival (OS) (HR=0.49 [95% CI, 0.38-0.64];
p<0.00001), reducing the risk of death by half compared to
chemotherapy alone. The study also showed a significant improvement
in progression-free survival (PFS) compared to chemotherapy alone
(HR=0.52 [95% CI, 0.43-0.64]; p<0.00001).iv
Changing survival expectations
"When I first learned I
had metastatic lung cancer, I was devastated. Like most people
diagnosed with this disease, it is at a late stage and the
prognosis was poor," said Larry
Frydman, a Toronto lung
cancer survivor. "I quickly learned that science was in overdrive.
Today's news of new innovative treatment options brings much needed
hope to Canadians living with lung cancer."
"Health Canada's decision means
that Canadians living with lung cancer will have a new tool to
fight this disease," said Shem
Singh, Executive Director of Lung Cancer Canada. "This is
important as innovative treatment options provide metastatic lung
cancer patients with the possibility of improved outcomes and the
hope for more time with family and loved ones."
About Lung Cancer
Lung cancer, which forms in the
tissues of the lungsv, usually within cells lining the
air passages, is the leading cause of cancer death
worldwide.vi Each year, more people die of lung cancer
than die of colon and breast cancers combined.vii The
two main types of lung cancer are non-small-cell and small-cell.
NSCLC is the most common type of lung cancer, accounting for 80 to
85 percent of all cases.viii The five-year relative
survival rate for patients suffering from highly advanced,
metastatic (Stage IV) lung cancers is estimated to be between 2 and
13 per cent.ix
Lung cancer is the most commonly diagnosed cancer in
Canada (excluding non-melanoma
skin cancers).x It is the leading cause of death from
cancer for both men and women in Canada. In 2017, an estimated 28,600 Canadians
were diagnosed with lung cancer; representing 14 per cent of all
new cancer cases, and 21,100 Canadians died from lung cancer,
representing 26 per cent of all cancer deaths.xi
About KEYTRUDA®
KEYTRUDA® is an
anti-PD-1 therapy that works by increasing the ability of the
body's immune system to help detect and fight tumour cells.
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.
KEYTRUDA® was first approved in Canada in 2015 and currently has eight
indications in a number of disease areas, including non-small cell
lung cancer, classical Hodgkin lymphoma, melanoma and bladder
cancer.
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
breakthrough 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 Canada
For over 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 about our operations in Canada, visit www.merck.ca and connect with us
on YouTube and Twitter @MerckCanada.
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
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|
i Canadian Cancer Society. Lung
cancer statistics. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=pe
|
ii Canadian Cancer Society. Cancerous
tumours of the lung. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/cancerous-tumours/?region=on
|
iii
Canadian Cancer Society. Survival statistics for non-small cell
lung cancer. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/lung/prognosis-and-survival/non-small-cell-lung-cancer-survival-statistics/?region=ab
|
iv New England Journal of Medicine.
Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung
Cancer. Available at
https://www.nejm.org/doi/full/10.1056/NEJMoa1801005
|
v Canadian Cancer Society. What is
lung cancer? Available at
http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/?region=on
|
vi World Health Organization. Cancer
fact sheet. Available at
http://www.who.int/mediacentre/factsheets/fs297/en/
|
vii World Health Organization. Cancer
fact sheet. Available at
http://www.who.int/mediacentre/factsheets/fs297/en/
|
viii Canadian Cancer Society.
Cancerous tumours of the lung. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/cancerous-tumours/?region=on
|
ix Canadian Cancer Society. Survival
statistics for non-small cell lung cancer. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/lung/prognosis-and-survival/non-small-cell-lung-cancer-survival-statistics/?region=ab
|
x Canadian Cancer Society. Lung
cancer statistics. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=pe
|
xi Canadian Cancer Society. Lung
cancer statistics. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=pe
|
SOURCE Merck