FDA Approves Post-Surgical Keytruda for Lung Cancer Subset

The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) to be given after surgery and platinum-based chemotherapy for patients with stage 1B, 2 or 3A non-small cell lung cancer (NSCLC), according to the agency.

The approval is based on findings from a randomized trial, KEYNOTE-091, which included 1,177 patients with NSCLC who had not undergone pre-surgical radiotherapy or chemotherapy. Participants in the study were randomly assigned to one of two groups: one group received intravenous Keytruda every three weeks for up to one year, while the other group received placebo. Then, 86% of patients (1,010 patients) received post-surgical (adjuvant) platinum-based chemotherapy after complete resection.

The main goal of the trial was to determine if Keytruda improve disease-free survival (the time after treatment for cancer when a patient survives without any symptoms or signs of the disease) over placebo, which it did. The average disease-free survival for patients given Keytruda was 58.7 months compared with 34.9 months in patients given a placebo.

In a prior discussion of the KEYNOTE-091 trial from January 2022, one expert explained that the advent of post-surgical Keytruda would be a welcomed addition for this patient population, as approximately 43% of patients with stage 1B, 2 or 3A NSCLC will experience their disease return after undergoing surgery. Of note, the goal of adjuvant therapy is often to prevent or slow cancer’s return after surgery.

Side effects observed in the KEYNOTE-091 trial were similar to what was previously seen in patients with NSCLC who were administered the immunotherapy agent, with the exception of hypothyroidism, hyperthyroidism (under- and over-active thyroid function, respectively), and pneumonitis, which is swelling of the lungs.

Two fatal instances of myocarditis (inflammation of the heart muscle) occurred on the trial.

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