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
SOURCE Merck
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/March2019/18/c0633.html