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

5 Important Facts About Lung Cancer Biomarkers (CNW Group/Merck Canada Inc.)

Lung Cancer Facts (CNW Group/Merck Canada Inc.)

• On average, 78 Canadians will be diagnosed with lung cancer every day¹
• Non-small cell lung cancer is the most common form of lung cancer, making up 80 to 85% of all cases²
• The five-year relative survival rate for patients suffering from highly advanced, metastatic (Stage IV) NSCLC is estimated to be 1%³
• KEYTRUDA^® (pembrolizumab) was found to provide a 40% reduction in the risk of death in first-line treatment versus chemotherapy⁴

KIRKLAND, QC, Sept. 20, 2017 /CNW Telbec/ - Merck (NYSE: MRK), known as MSD outside Canada and the United States, announced today that KEYTRUDA^® (pembrolizumab) as monotherapy is now indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have high PD-L1 expression, with no EGFR or ALK genomic tumour aberrations and no prior systemic chemotherapy treatment.

A validated biomarker test to determine a patient's tumour proportion score (TPS) enables physicians to determine the level of PD-L1 expression on a patient's tumour cells. A PD-L1 expression on at least 50% of tumour cells (TPS ≥50%) is associated with a higher response rate.^4,5

Non-small cell lung cancer is a deadly disease
Lung cancer, which forms in the cells of the lungs,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 80 to 85 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.³ On average, 58 Canadians will die from lung cancer every day.¹

"NSCLC is an aggressive disease that can affect any Canadian with lungs," explains Dr. Rosalyn Juergens, Medical Oncologist with the Juravinski Cancer Center in Hamilton, Ontario. "We believe speed and the right diagnostic tools, like the PD-L1 biomarker test, are critical to treating lethal diseases like lung cancer. The key is bringing the right treatment as early as possible to the patients most likely to benefit. For lung cancer patients, it's critical we avoid losing time on treatments that may not work for them."

"At Lung Cancer Canada, every day we see how lung cancer shocks, overwhelms and separates families" said Shem Singh, Executive Director, Lung Cancer Canada. "Patients need treatment options in the first line setting that both work and allow them to spend quality time with their families. KEYTRUDA offers this potential for patients meeting the criteria. For this population of patients, every moment counts."

Our Commitment to Patients
The approval in Canada of this first line indication for KEYTRUDA is a milestone for Merck's immuno-oncology pipeline. 

"Lung cancer is the leading cause of cancer death for both men and women in Canada,¹ which makes this new indication especially significant. We look forward to working with provinces and other jurisdictions to ensure that Canadians who need immunotherapy for first line treatment of metastatic NSCLC have rapid access to KEYTRUDA." says Chirfi Guindo, President and Managing Director, Merck Canada Inc. "Merck has a long history of bringing innovative treatments to patients suffering from cancer, and we are proud to be at the forefront of this new era in immuno-oncology."

KEYTRUDA is also approved in Canada for the treatment of metastatic melanoma.

Data Supporting First-Line Approval
The approval was based on data from KEYNOTE-024, a randomized, open-label, phase 3 study evaluating KEYTRUDA monotherapy compared to standard of care platinum-containing chemotherapy for the treatment of patients with both squamous (18%) and non-squamous (82%) metastatic NSCLC. The study enrolled patients who had not received prior systemic chemotherapy treatment for their metastatic disease and whose tumours had high PD-L1 expression (TPS of 50 percent or more) and with no EGFR or ALK aberrations. The study randomized 305 patients to receive KEYTRUDA (200 mg every three weeks) or investigator-choice standard of care platinum-based chemotherapy (pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+cisplatin, gemcitabine+carboplatin, or paclitaxel+carboplatin). Pemetrexed maintenance therapy was permitted for patients with non-squamous histologies.

The primary endpoint was progression-free survival (PFS); additional efficacy outcome measures were overall survival (OS) and overall response rate (ORR). Based on an interim analysis demonstrating KEYTRUDA (pembrolizumab) was superior compared to chemotherapy for both the primary endpoint of PFS and the secondary endpoint of OS, the trial was stopped early in June 2016 to give patients still on chemotherapy the opportunity to receive KEYTRUDA. Findings demonstrated that KEYTRUDA reduced the risk of progression or death by 50 percent compared to chemotherapy (HR, 0.50 [95% CI, 0.37, 0.68]; p<0.001). Additionally, KEYTRUDA resulted in a 40 percent reduction in the risk of death compared to chemotherapy (HR, 0.60 [95% CI, 0.41, 0.89]; p=0.005). 

About KEYTRUDA (pembrolizumab)
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-1.⁸ 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.⁸

In Canada, KEYTRUDA has been issued marketing authorization without conditions for the treatment of patients with:

• Unresectable or metastatic melanoma who have not received prior treatment with ipilimumab. Subjects with BRAF V600 mutant melanoma may have received prior BRAF inhibitor therapy.
• Metastatic NSCLC as monotherapy, in adults whose tumours have high PD-L1 expression (TPS ≥50%) as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.

KEYTRUDA has also been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit 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 as per proposed indication.
• Metastatic NSCLC as monotherapy, in adults whose tumours express PD-L1 (TPS ≥ 1%) 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 received authorized therapy for these aberrations prior to receiving KEYTRUDA.⁸

Merck is advancing a broad and fast-growing clinical development program that has rapidly expanded to encompass more than 30 tumour types in more than 550 clinical trials, of which more than 300 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 tumours, 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: https://pdf.hres.ca/dpd_pm/00040232.PDF

About Merck
For over a century, Merck has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Merck is a leading global biopharmaceutical company with a diversified portfolio of prescription medicines, vaccines, biologic therapies, including biosimilars, and animal health products. In Canada, Merck is a leader in a broad range of areas such as oncology, infectious diseases, diabetes, and vaccines, and markets more than 250 pharmaceutical and animal health products.

Based in Montréal, Québec, Merck employs approximately 810 people across Canada. Merck is one of the top R&D investors in Canada, with investments totalling $25.1 million in 2015 and more than $1 billion since 2000. For more information about our operations in Canada, visit www.merck.ca and connect with us on YouTube and Twitter @MerckCanada.

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 June 19, 2017.
	2.	Canadian Cancer Society. Malignant tumours of the lung. Available at http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/cancerous-tumours/?region=on. Accessed on August 28, 2017.
	3.	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 June 19, 2017.
	4.	Reck M, Rodriguez-Abreu D, Robinson AG, et al. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. NEJM 2016;375:1823-33
	5.	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
	6.	Canadian Cancer Society. What is lung cancer? Available at http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/non-small-cell-lung-cancer/?region=on. Accessed on June 19, 2017.
	7.	World Health Organization. Cancer fact sheet. Available at http://www.who.int/mediacentre/factsheets/fs297/en/. Accessed on June 19, 2017.
	8.	KEYTRUDA^® Product Monograph. Merck Canada Inc. July 20, 2017. Available at https://pdf.hres.ca/dpd_pm/00040232.PDF

SOURCE Merck Canada Inc.

Media Contacts: Annick Robinson, [phone]; Ana Gajic, NATIONAL Public Relations, [phone], [email protected]; Amélie Forcier, NATIONAL Public Relations, [phone], [email protected]; Investor Contact: Teri Loxam, [phone]

Related Links

www.merck.ca