Merck’s Keytruda (pembrolizumab) is now available as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) in Canada. Adults whose tumors express high PD-L1, along with a few other criteria, will be able to receive Keytruda as a monotherapy to treat their cancer.

Canadian patients who are prescribed Keytruda must have metastatic NSCLC (cancer that has spread to other locations in the body), no EGFR or ALK tumor abnormalities, genes that promote cancer development, and no prior systemic chemotherapy treatment. NSCLC is the most common type of lung cancer.

Keytruda is a type of drug called a checkpoint inhibitor because it stops tumors from blocking the body’s own immune response to tumors and allowing natural defenses to kick in.

“Lung cancer is the leading cause of cancer death for both men and women in Canada, which makes this new indication especially significant,” Chirfi Guindo, president and managing director of Merck Canada, said in a press release. “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.”

“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,” Guindo added.

Approval for this indication of Keytruda was based on the results of the KEYNOTE-024 Phase 3 trial (NCT02142738). Keytruda was seen to reduce the risk of progression or death by 50% compared with chemotherapy in patients with metastatic NSCLC tested in the trial. The drug provided a 40% reduction in the risk of death when used first to treat patients compared with chemotherapy.

Keytruda is also approved in Canada for the treatment of metastatic melanoma and in the U.S. for certain patients with other types of solid tumors. Merck is known as MSD outside Canada and the U.S.

“NSCLC is an aggressive disease that can affect any Canadian with lungs,” said 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 of the nonprofit 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.”