Keytruda Now FDA-Approved for Patients with Melanoma

MelanomaThe KEYNOTE-054 Phase 3 clinical trial (NCT02362594) showed that the immune checkpoint inhibitor drug Keytruda decreased the risk of melanoma recurrence or death by 43% in comparison to a placebo drug. The drug has thus been approved by the U.S. Food and Drug Administration (FDA) to treat patients with stage-3 melanoma (cancer has spread to the lymph nodes but not to other organs — who have had surgery to remove the tumor.

In a recent press release, Roy Baynes, chief medical officer at Merck Research Laboratories, said “In the fight against cancer, progress is made one step at a time, and today we’re pleased to take another important step — making Keytruda available as an adjuvant therapy for patients with stage III melanoma.”

Keytruda was developed by Merck to allow the immune system to find and attack cancerous cells. By binding to a protein called PD-1 on immune T cells, it blocks an interaction with its ligand PD-L1, a protein that cancerous cells create to avoid immune system detection.

melanomaKEYNOTE-054 tested Keytruda on a group of patients with stage-3 melanoma who had full resection of their tumor. This group was also at a high risk of seeing the disease recur. The trial included 1,019 patients with a median age of 54. All of the patients had surgery with lymph node removal, and some had radiation therapy, within 13 weeks of beginning the study. Patients were randomly assigned either Keytruda or a placebo drug, and they were given it every three weeks for a year or until their disease recurred or they experienced toxic side effects.

The goal of the study was to see if Keytruda could prevent recurrence of the disease in patients with or without PD-L1 positive tumors (84% of the patients in this study did have PD-L1 positive tumors.) The study also hoped to determine Keytruda’s effect on metastasis, death, survival, and number of adverse events.

melanomaThe results showed that 75.4% of patients who received Keytruda were alive and free of disease for at least one year. This is in comparison to 61% of patients who received placebo. This means that risk of recurrence or death was reduced by 43%, and 46% in patients who had PD-L1 positive tumors. There was also a 47% reduced risk of metastasis compared to 29.7% with the placebo drugs. 16.7% of patients did experience the spread of disease within 18 months.

14.7% of patients experienced negative side effects while taking Keytruda compared to 3.4% of patients who took the placebo drug. One patient taking Keytruda died from chronic, progressive muscle inflammation, which is a noted side effect of the drug.

Alain Algazi, MD, associate clinical professor of medicine at the University of California-San Francisco Medical Center, is very enthusiastic about the promise Keytruda holds for cancer patients, and now for patients especially with stage III melanoma. “Keytruda has demonstrated significant improvement in recurrence-free survival among stage III melanoma patients,” he said. “And we now have a new option to help patients who have a high risk of recurrence.”