Lung Cancer Immunotherapy Approved for Use Before and After Surgery
The FDA has approved pembrolizumab for the treatment of certain surgically removable tumors before and after resection.
The U.S. Food and Drug Administration (FDA) has approved the immunotherapy pembrolizumab (Keytruda) for use in combination with platinum chemotherapy before surgery and on its own after surgery in patients with surgically removable non-small cell lung cancer (NSCLC).
Pembrolizumab is a type of immunotherapy called an immune checkpoint inhibitor. These drugs block signals that cancer cells use to protect themselves from the immune system; pembrolizumab inhibits PD-1, a receptor of such signals that is found on immune cells.
The combination of pembrolizumab and certain chemotherapies was approved for the first-line treatment of patients with metastatic NSCLC in 2018. This was followed by the 2023 approval for the use of single-agent pembrolizumab to prevent the recurrence of NSCLC tumors that had been surgically removed and treated with chemotherapy. The current approval expands the use of chemotherapy plus pembrolizumab to shrink resectable NSCLC tumors before surgery and allows patients to continue pembrolizumab treatment alone after surgery.
This approval was based on results from the multicenter, randomized, double-blind, phase III KEYNOTE-671 trial, which enrolled 797 patients with stage 2, 3A, or 3B NSCLC that could be surgically removed and had not been previously treated. Prior to surgery, patients were randomly assigned to receive platinum-based chemotherapy plus either pembrolizumab or a placebo. After surgery, they continued with up to 13 cycles of single-agent pembrolizumab or placebo.
The median overall survival was not reached among patients receiving pembrolizumab and was 52.4 months among patients receiving placebo. The median event-free survival, defined as the amount of time a patient survives without disease progression or a relapse, was also not reached among patients receiving pembrolizumab and was 17 months among patients receiving placebo.
Non-small cell lung cancer is the most common type of lung cancer, accounting for over 80% of cases. Typically, around 25% of NSCLC cases are diagnosed at stage 2, 3A, or 3B. According to federal statistics, it was estimated that 238,340 individuals would be diagnosed with lung cancer and 127,070 patients would die of the disease in the United States in 2023.
The FDA rendered its decision on October 16, 2023.
