Download New Treatment Now Available for Canadians with Metastatic Non

News Release
FOR IMMEDIATE RELEASE
New Treatment Now Available for Canadians with
Metastatic Non-Small Cell Lung Cancer
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On average, 73 Canadians will be diagnosed with lung cancer every day 1
Non-small cell lung cancer is the most common form of lung cancer, making up 85
to 90 per cent of all cases 2
Kirkland, Quebec – April 20, 2016 – Merck (NYSE: MRK), known as MSD outside Canada
and the United States, announced today that KEYTRUDA ® (pembrolizumab) received
conditional approval for the treatment of Canadians living with metastatic non-small cell lung
cancer (NSCLC) whose tumours express PD-L1 (as determined by a validated test) and who
have disease progression on or after platinum-containing chemotherapy. Patients with EGFR
or ALK genomic tumour aberrations should have disease progression on authorized therapy for
these aberrations prior to receiving KEYTRUDA ®. KEYTRUDA® has been issued marketing
authorization with conditions, pending the results of studies to verify its clinical benefit.
A validated test will enable physicians to determine the level of PD-L1 expression in a
patient’s tumor cells. A PD-L1 expression on at least 50% of tumour cells was associated with a
higher response rate and better patient outcomes. 4,5
Non-small cell lung cancer is a deadly disease
Lung cancer, which forms in the tissues of the lungs, 6 usually within cells lining the air
passages,6 is the leading cause of cancer death worldwide. 7 The two main types of lung cancer
are non-small cell and small cell. 6 NSCLC is the most common type of lung cancer, accounting
for 85 to 90 percent of all cases. 2
The five-year relative survival rate for patients suffering from highly advanced, metastatic
(Stage IV) NSCLC is estimated to be one percent. 8 On average, 57 Canadians will die from lung
cancer every day.1
“Despite being the leading cause of cancer in Canadians, treatments for non -small cell
lung cancer have essentially remained the same for the last three decades,” explains Dr.
Natasha Leighl, Lung Site Lead, Division of Medical Oncology, Princess Margaret Cancer
Centre. “The discovery of immunotherapies represents a major advancement for treating
lung cancer, offering the promise of longer and better quality of life.”
KEYTRUDA reactivates the immune system against cancer
The immune system depends on T-cells to find and eliminate cancer cells. Cancer cells on
the other hand, have evolved ways to hide from T-cells by sending signals that interfere with their
normal function through a protein called PD-1.3 By preventing the PD-1 receptor from binding to
its two ligands, KEYTRUDA blocks signals that cancer cells may send, reactivating cancer specific killer T-cells and restoring the anti-tumour immune response. 3
"The approval of Keytruda means that there is another option for lu ng cancer patients
and
their
families,"
says
Casey
Cosgrove
Vice-President Lung Cancer Canada.
"Immunotherapies offer patients and their families a chance to spend quality time together while
still undergoing treatment. More research and innovations are ne eded to increase survival in
lung cancer.” Casey is living with stage IV lung cancer and can attest first hand to the chance to
fight that immunotherapies may offer.
Our Commitment to Patients
The approval in Canada of this second indication for KEYTRUDA is a milestone for
Merck’s immuno-oncology pipeline.
“Merck is advancing a broad and fast-growing pembrolizumab clinical development
program that has rapidly expanded to encompass multiple tumor types in more than 250 clinical
trials around the world,” says Chirfi Guindo, President and Managing Director Merck Canada
Inc. “Merck has a long history of bringing innovative treatments to patients suffering from
cancer. Today, we are proud to add KEYTRUDA to this list of important innovations to lung
cancer patients.”
Pembrolizumab is currently being investigated in more than 30 tumor types and has
also been approved in Canada for the treatment of metastatic melanoma.
About KEYTRUDA
KEYTRUDA (pembrolizumab) is indicated for the treatment of patients with metastatic
non-small cell lung carcinoma (NSCLC) whose tumours express PD-L1 (as determined by a
validated test) and who have disease progression on or after platinum-containing
chemotherapy.3 Patients with EGFR or ALK genomic tumour aberrations should have disease
progression on authorized therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA has been issued marketing authorization with conditions, pending the results of
studies to verify its clinical benefit. 3 KEYTRUDA is available as a single 30-minute infusion
every 3 weeks.3
In the KEYNOTE-001 study, 61 patients with PD-L1-positive NSCLC were treated with
KEYTRUDA every 2 or 3 weeks. 4 Tumour response was reported for 41% of patients, a majority
of whom remain responsive (84%). The median duration of response has not yet been
reached.4 An improvement in survival or disease-related symptoms has not yet been
established.4
In Canada, KEYTRUDA has also been approved for the treatment of patients with
unresectable or metastatic melanoma and disease progression following ipilimumab therapy
and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor. 3 An improvement in
survival or disease-related symptoms has not yet been established. 3
Merck is advancing a broad and fast-growing clinical development program that has
rapidly expanded to encompass more than 30 tumor types in more than 250 clinical trials, of
which more than 100 trials combine pembrolizumab with other cancer treatments.
Registration-enabling trials of pembrolizumab are currently enrolling patients in melanoma,
NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal
cancer, breast cancer, Hodgkin lymphoma, multiple myeloma and other tumors, with further
trials in planning for other cancers. The safety and efficacy of KEYTRUDA for these types of
cancer have not been established. For more information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
For more information please consult the KEYTRUDA product monograph available at:
http://www.merck.ca/assets/en/pdf/products/KEYTRUDA-PM_E.pdf
About Merck
For 125 years, Merck has been a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada. 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 healthcare through far -reaching policies,
programs and partnerships. For more information about our operations in Canada, visit
www.merck.ca and connect with us on YouTube.
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. There can be no guarantees with respect to pipeline products that the products
will receive the necessary regulatory approvals or that they will prove to be commercially
successful. 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 condi tions 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 he alth 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 2014 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).
Media Contact: Ani Armenian
Investor Contact: Justin Holko
(514) 428-3395
(908)-740-1879
###
References:
1. Canadian Cancer Society. Lung cancer statistics. Available at
http://www.cancer.ca/en/cancerinformation/cancertype/lung/statistics/?region=on. Accessed on
March 21, 2016.
2. Canadian Cancer Society. Malignant tumours of the lung. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/non-small-cell-lungcancer/?region=on. Accessed on March 21, 2016.
3. KEYTRUDA ® Product Monograph. Merck Canada Inc. April 15, 2016.
4. Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the Treatment of Non–Small-Cell Lung
Cancer. N Engl J Med 2015;372:2018-28.
5. Herbst RS, Baas P, Kim D, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial.
Lancet 2016; 387: 1540–50.
6. Canadian Cancer Society. What is lung cancer? Available at http://www.cancer.ca/en/cancerinformation/cancer-type/lung/lung-cancer/?region=on. Accessed on March 21, 2016.
7. World Health Organization. Cancer fact sheet. Available at
http://www.who.int/mediacentre/factsheets/fs297/en/. Accessed on March 21, 2016.
8. 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/survivalstatistics/?region=on. Accessed on March 21, 2016.