New Cancer Immunotherapy Indication for Canadian Patients with Untreated Metastatic Melanoma

• Melanoma kills over 1,100 Canadians every year¹
• KEYTRUDA is now indicated for metastatic melanoma in the first-line setting
• New indication marks third approval for KEYTRUDA^® in Canada
• Simple dosing regimen: 30-minute infusion, once every 3 weeks

KIRKLAND, QC, May 31, 2016 /CNW Telbec/ - Merck (NYSE: MRK), known as MSD outside Canada and the United States, announced today that KEYTRUDA^® (pembrolizumab) received approval for the treatment of patients with unresectable or metastatic melanoma who have not received prior treatment with ipilimumab. KEYTRUDA is now the first and only anti-PD1 agent approved for first-line treatment regardless of BRAF mutation status.

"We are excited to share this announcement with Canadian cancer patients during Melanoma Awareness Month," says Chirfi Guindo, President and Managing Director Merck Canada Inc.  "The development program for pembrolizumab promises to continue to deliver advances for patients in the years to come. We currently have over 250 clinical trials on-going in 30 different tumour types, with positive data already published from 20 of them. We are committed to research and development and to bringing innovative therapies to patients. Saving and improving lives is at the heart of everything we do."

Melanoma is a very serious form of skin cancer  
In 2015, it was estimated that 6,800 Canadians were diagnosed with melanoma, with 1,150 patients dying of the disease. Metastatic melanoma is particularly devastating. Fewer than 1 in 5 patients with metastatic melanoma are expected to survive beyond 5 years.¹

"When I was diagnosed with advanced melanoma in 2013, my outlook was grim as there weren't a lot of treatment options at the time," says Alan Taylor, an advanced melanoma patient from Toronto. "I am so grateful I was eventually able to access and respond to KEYTRUDA and have this quality time to spend with my family. Now it's even better news for other patients who will be able to access it earlier in their treatment."

"For years, melanoma has been a difficult type of cancers to treat, where most treatments provided limited benefit and possibly some harsh toxicity," explains Dr. Marcus Butler, Medical Oncologist at the Princess Margaret Cancer Centre. "The development of immunotherapies has been a true innovation in the care of melanoma patients. Now we see many patients living longer, with good quality of life.  We are not there yet, but there is hope that one day melanoma might become a manageable disease for all patients."

KEYTRUDA is now indicated for metastatic melanoma in the first-line setting
"Canadian melanoma patients have been waiting a long time for this announcement," said Annette Cyr, Chair and Founder, Melanoma Network of Canada. "We are so fortunate to be able to access clinical trials, but access to this new indication in the first line setting is a welcome additional therapy for melanoma patients. The tolerability of this class of immuno-oncology treatment is bringing new hope for patients to improve their quality of life while in treatment, and have a longer, durable response than the current standard of care."

"The most devastating diagnosis a melanoma patient can hear is that their cancer has metastasized," shared Kathy Barnard, President and Founder of the Save Your Skin Foundation. "Until now, these very sick patients had few options, and a bleak outlook on how their disease would affect both their quality and quantity of life. The hope immuno-oncology is bringing to melanoma patients is to see improvements on both those fronts. We welcome the news that patients with advanced melanoma will now have access to this new treatment in the first line setting. Access to clinical trials and innovative therapies like this one are critical for patients."

About KEYTRUDA (pembrolizumab)
KEYTRUDA indicated for the treatment of patients with unresectable or metastatic melanoma who have not received prior treatment with ipilimumab, has been issued marketing authorization without conditions. Subjects with BRAF V600 mutant melanoma may have received prior BRAF inhibitor therapy.² KEYTRUDA is administered as a single 30-minute intravenous infusion every 3 weeks.²

In the Phase III KEYNOTE-006 registration study, patients with unresectable or metastatic melanoma were treated with either KEYTRUDA every 2 or 3 weeks, or ipilimumab, considered to be the standard of care at the time.³ KEYTRUDA significantly improved overall survival, reducing the risk of death significantly by 31 to 37% vs.  ipilimumab (p<0.004).³ Tumour response rates more than doubled with KEYTRUDA vs. ipilimumab (33 to 34% vs. 12%, p<0.001).³

Because KEYTRUDA demonstrated significant survival benefit vs. ipilimumab, the study was stopped early to allow patients receiving ipilimumab to switch to KEYTRUDA.³

In Canada, KEYTRUDA is also 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 inhibitor and 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. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on authorized therapy for these aberrations prior to receiving KEYTRUDA.²  An improvement in survival or disease-related symptoms has not yet been established.²  KEYTRUDA has been issued these marketing authorizations with conditions, pending the results of studies to verify its clinical benefit.²

For more information about KEYTRUDA, consult the product monograph.

KEYTRUDA reactivates the immune system against cancer
T-cells are a specialized type of cells that can recognize, attack and destroy foreign invaders of the human body including cancer cells. PD-1 is a protein that limits the activity of T-cells in normal tissue. Tumour cells can use this process to suppress T-cell by sending signals through PD-1.² When the T-cells stop attacking, the cancer cells keep growing undisturbed.

KEYTRUDA binds to PD-1 and blocks the signals that cancer cells may send, therefore reactivating cancer-specific killer T-cells and restoring the anti-tumour immune response.² 

About pembrolizumab's broad and fast growing development program
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. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

For more information about cancer, please see our video. 
For more information about immuno-oncology, please see our video. 

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 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 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. Canadian Cancer Society. Melanoma statistics. Available at http://www.cancer.ca/en/cancer-information/cancer-type/skin-melanoma/statistics/?region=on. Accessed on April 15, 2016.
2. KEYTRUDA^® Product Monograph. Merck Canada Inc. May 6, 2016.
3. Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med 2015;372:2521-32. 

SOURCE Merck Canada Inc.

Video with caption: "Video: Cancer The Big Picture: Demystifying Immuno-Oncology". Video available at: http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20160531_C4121_VIDEO_EN_701924.mp4&posterurl=http%3a%2f%2fphotos.newswire.ca%2fimages%2f20160531_C4121_PHOTO_EN_701924.jpg&order=1&jdd=20160531&cnum=C4121

PDF available at: http://stream1.newswire.ca/media/2016/05/31/20160531_C4121_PDF_EN_701940.pdf

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