Merck's KEYTRUDA™ (pembrolizumab) receives conditional approval in Canada for the treatment of advanced melanoma

KEYTRUDA^TM is the First Anti-PD-1 Immuno-Oncology Therapy Available in Canada

KIRKLAND, QC, June 8, 2015 /CNW Telbec/ - Merck Canada Inc. announced today that KEYTRUDA^TM (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 difficult-to-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 what 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, open-label, 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.

For 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 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; Merck'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 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 
3. KEYTRUDA^TM 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/cancer-information/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

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SOURCE Merck Canada Inc.

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Annick Robinson, Merck Canada, [phone]; Justin Holko, Merck - Investor contact, [phone]; Stephanie Lyttle, [phone], [email protected]; Astrid Morin, [phone], [email protected]

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