Canadian patients with metastatic non-small cell lung cancer (NSCLC) can now receive Merck‘s Keytruda (pembrolizumab) as their first treatment following a recent approval by health authorities.
The approval covers patients who have tumors with a high content of PD-L1, no tumor mutations in the EGFR or ALK genes, and no earlier chemotherapy treatment.
“Lung cancer is the leading cause of cancer death for both men and women in Canada, 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 NSLC have rapid access to Keytruda,” Chirfi Guindo, president and managing director of Merck Canada (known as MSD outside the U.S. and Canada), said in a press release.
In this type of lung cancer, higher levels of PD-L1 have been linked to a better response to Keytruda treatment, and physicians can use a validated test to determine the PD-L1 content of a tumor.
“NSCLC is an aggressive disease that can affect any Canadian with lungs,” said Rosalyn Juergens, medical oncologist at 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,” she added.
The approval was based on data from the Phase 3 KEYNOTE-024 clinical trial (NCT02142738), which compared Keytruda as the sole treatment to platinum chemotherapy, currently the standard of care for metastatic NSCLC.
Since findings showed that Keytruda lowered the risk of progression or death by 50%, and the risk of death by 40% compared to chemotherapy, the trial was stopped at an interim analysis in 2016 to allow patients in the control group to receive Keytruda.
“At Lung Cancer Canada, every day we see how lung cancer shocks, overwhelms and separates families,” said Shem Singh, executive director of 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,” Singh added.
