New Treatment Now Available for Canadians with Metastatic Non-Small Cell Lung Cancer

•  On average, 73 Canadians will be diagnosed with lung cancer every day¹

• Non-small cell lung cancer is the most common form of lung cancer, making up 85 to 90 per cent of all cases²

KIRKLAND, QC, April 20, 2016 /CNW Telbec/ - 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 lung 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 needed 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 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).

References:

1.	Canadian Cancer Society. Lung cancer statistics. Available at http://www.cancer.ca/en/cancer-information/cancer-type/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-lung-cancer/?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-L1-positive, 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/cancer-information/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/survival-statistics/?region=on. Accessed on March 21, 2016.

SOURCE Merck Canada Inc.

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