Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that Health Canada has expanded the label for KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy, to include approval for the treatment of metastatic non-squamous NSCLC, in combination with pemetrexed and platinum chemotherapy, in adults with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.

“Lung cancer is the deadliest form of cancer in Canada. It is vital that we continue to develop new approaches to treating this, sadly, too common disease,” said Dr. Normand Blais, medical oncologist at the Centre Hospitalier Universitaire de Montréal. “Immuno-oncology therapies are changing the way we treat lung cancer in Canada and helping to change survival expectations for these patients.”

In the pivotal, Phase 3 KEYNOTE-189 trial of patients regardless of PD-L1 tumour expression status, KEYTRUDA^®, in combination with pemetrexed and platinum chemotherapy, demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001), reducing the risk of death by half compared to chemotherapy alone. The study also showed a significant improvement in progression-free survival (PFS) compared to chemotherapy alone (HR=0.52 [95% CI, 0.43-0.64]; p><0.00001).^iv

Changing survival expectations

“When I first learned I had metastatic lung cancer, I was devastated. Like most people diagnosed with this disease, it is at a late stage and the prognosis was poor,” said Larry Frydman, a Toronto lung cancer survivor. “I quickly learned that science was in overdrive. Today’s news of new innovative treatment options brings much needed hope to Canadians living with lung cancer.”

“Health Canada’s decision means that Canadians living with lung cancer will have a new tool to fight this disease,” said Shem Singh, Executive Director of Lung Cancer Canada. “This is important as innovative treatment options provide metastatic lung cancer patients with the possibility of improved outcomes and the hope for more time with family and loved ones.”

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs^v, usually within cells lining the air passages, is the leading cause of cancer death worldwide.^vi Each year, more people die of lung cancer than die of colon and breast cancers combined.^vii The two main types of lung cancer are non-small-cell and small-cell. NSCLC is the most common type of lung cancer, accounting for 80 to 85 percent of all cases.^viii The five-year relative survival rate for patients suffering from highly advanced, metastatic (Stage IV) lung cancers is estimated to be between 2 and 13 per cent.^ix

Lung cancer is the most commonly diagnosed cancer in Canada (excluding non-melanoma skin cancers).^x It is the leading cause of death from cancer for both men and women in Canada. In 2017, an estimated 28,600 Canadians were diagnosed with lung cancer; representing 14 per cent of all new cancer cases, and 21,100 Canadians died from lung cancer, representing 26 per cent of all cancer deaths.^xi

About KEYTRUDA^®

KEYTRUDA^® is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. KEYTRUDA^® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.

KEYTRUDA^® was first approved in Canada in 2015 and currently has eight indications in a number of disease areas, including non-small cell lung cancer, classical Hodgkin lymphoma, melanoma and bladder cancer.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 750 trials studying pembrolizumab across a wide variety of cancers and treatment settings. This clinical program seeks to understand the role of pembrolizumab across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with this medication, including exploring several different biomarkers.

Our Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.

About Merck Canada

For over a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. 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 health care through far-reaching policies, programs and partnerships.

Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola.