Download (pembrolizumab) Receives Conditional Approval in Canada for the

News Release
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Media Contact:
Annick Robinson
Investor Contact:
Justin Holko
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Merck’s KEYTRUDATM (pembrolizumab) Receives Conditional Approval in Canada
for the Treatment of Advanced Melanoma
KEYTRUDATM is the First Anti-PD-1 Immuno-Oncology Therapy
Available in Canada
Kirkland, Quebec, June 8, 2015 – Merck Canada Inc. announced today that KEYTRUDATM
(pembrolizumab) was authorized for sale with conditions by Health Canada on May 19, 2015.
KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the
body’s immune system to fight advanced melanoma, the most serious form of skin cancer1. It is
the first of a new class of therapies called anti-PD-1s approved in Canada. Among the different
types of skin cancer, melanoma has the greatest metastatic potential2.
KEYTRUDA is indicated 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 inhibitor3. The product has been approved in Canada under
the Notice of Compliance with Conditions (NOC/c) policy on the basis of promising evidence of
clinical effectiveness and pending the results of trials to verify its anticipated benefit.
“All of us at Merck Canada are thrilled with KEYTRUDA being available in Canada for
the treatment of advanced melanoma, as it provides new therapy to patients facing this difficultto-treat cancer,” said Chirfi Guindo, Managing Director, Merck Canada Inc. “This new product
embodies Merck’s unwavering commitment to be at the forefront of scientific discovery and
innovation to help Canadian patients.”
"The conditional approval of this new product in Canada marks a new era in how
advanced melanoma will be treated in this population with a high unmet medical need," said Dr.
Marcus Butler, Medical Oncologist at Princess Margaret Cancer Centre, Director of Princess
Margaret Immune Monitoring Laboratory. "For patients suffering from symptoms of their
advanced disease, the product is not only effective, but also well-tolerated.”
“We commend the decision to issue an NOC/c for KEYTRUDA in Canada for metastatic
melanoma, the deadliest form of skin cancer,” said Kathy Barnard, Founder of the Save Your
Skin Foundation. “As a survivor of advanced melanoma myself,” she adds, “I know first-hand
-2what great news this is for Canadians suffering from this deadly disease, who might otherwise
be out of treatment options. Immuno-oncology is an important development in cancer
treatment.”
“It is hard to contain my enthusiasm,” added Annette Cyr, Chair and Founder, Melanoma
Network of Canada. “This new therapy brings us hope to have regression of the disease,
improved quality of life and the potential to have a life free of this aggressive cancer.”
About Melanoma
Melanoma, the most serious form of skin cancer1, is characterized by the uncontrolled
growth of pigment-producing cells. The incidence of melanoma has been increasing over the
past four decades – approximately 232,130 new cases were diagnosed worldwide in 2012.
In Canada, it is estimated that, in 2015, 6,800 Canadians will be diagnosed with
melanoma, while 1,150 Canadians will die from melanoma4.
The five-year survival rates for advanced or metastatic melanoma (Stage IV) are
estimated to be 15 to 20 percent5.
About KEYTRUDA (pembrolizumab)
KEYTRUDA works by helping the immune system fight cancer. It is a high affinity
antibody against programmed-death-receptor-1 (PD-1). By inhibiting the PD-1 receptor from
binding to its ligands, the product reactivates tumour-specific cytotoxic T lymphocytes in the
tumour microenvironment and thereby also reactivates anti-tumour immunity.
The conditional approval of KEYTRUDA was based on data from a multicenter, openlabel, randomized, dose-comparative study cohort of the ongoing KEYNOTE-001 Phase 1 trial
in patients with unresectable or metastatic melanoma and progression of disease. For the
recommended 2 mg/kg dose based on data in 89 patients, the overall response rate was 24
percent (95% CI: 15, 34), with one complete response and 20 partial responses (21/89). At the
time of analysis, 86 percent (18/21) of patients with objective responses had ongoing responses
with durations ranging from 6+ to 37+ weeks, including eight patients with ongoing responses of
6 months or longer. Fourteen percent (3/21) had progression of disease 2.8, 2.9, and 8.2
months after initial response. The most common treatment-related adverse reactions (reported
in more than 10% of patients) included arthralgia, diarrhea, fatigue, nausea, pruritus and rash.
Immune-mediated adverse reactions occurred in patients receiving KEYTRUDA. In
clinical trials, most immune-mediated adverse reactions were reversible and managed with
interruptions of KEYTRUDA, administration of corticosteroids and/or supportive care.
-3For further information on KEYTRUDA, please consult the product monograph available
at http://www.merck.ca/assets/en/pdf/products/KEYTRUDA-PM_E.pdf
Our Focus on Cancer
Our goal is to translate breakthrough science into biomedical innovations to help people
with cancer worldwide. For Merck Oncology, helping people fight cancer is our passion,
supporting accessibility to our cancer medicines is our commitment, and pursuing research in
immuno-oncology is our focus to potentially bring new hope to people with cancer. For more
information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is
known as MSD outside Canada and the United States. Through our prescription medicines,
vaccines, biologic therapies, and consumer care 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.
Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe
harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These
statements are based upon the current beliefs and expectations of Merck’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 forwardlooking 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; Merck’s ability to
-4accurately predict future market conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk; dependence on the effectiveness of
Merck’s patents and other protections for innovative products; and the exposure to litigation,
including patent litigation, and/or regulatory actions.
Merck 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 Merck’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).
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References:
1. Medline Plus. (May 2012). Melanoma. Retrieved on May 20, 2015 from
http://www.nlm.nih.gov/medlineplus/ency/article/000850.htm
2. National Cancer Institute at the National Institutes of Health. Skin Cancer. Retrieved on May 20, 2015 from
http://www.cancer.gov/types/skin
TM
3. KEYTRUDA Product Monograph. Merck Canada Inc. Available at
http://www.merck.ca/assets/en/pdf/products/KEYTRUDA-PM_E.pdf
4. Canadian Cancer Society. Melanoma. Retrieved on May 20, 2015 from http://www.cancer.ca/en/cancerinformation/cancer-type/skin-melanoma/statistics/?region=on
5. American Cancer Society. Melanoma Skin Cancer. Retrieved on May 20, 2015 from
http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-survival-rates