FDA Approves Pre- and Postsurgical Keytruda for Advanced Lung Cancer

The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) for the perioperative treatment of patients with resectable (able to be removed via surgery) stage 2, 3A or 3B non-small cell lung cancer (NSCLC), according to the agency.

The approval is based off findings from the randomized, phase 3 KEYNOTE-671 trial, which included 786 patients who were randomly assigned to receive either presurgical Keytruda plus chemotherapy followed by postsurgical Keytruda administered as a singleagent or presurgical placebo plus chemotherapy, followed by placebo.

Study findings, which will be presented at the 2023 European Society for Medical Oncology (ESMO 2023) Congress, showed that the main goal of the trial was met: overall survival (time from treatment until death of any cause) was significantly better in patients who received the Keytruda-containing regimen than those who did. Specifically, the median overall survival was not reached in the Keytruda group, meaning that not enough patients in the group had died to determine an average time until death, and 52.4 months in the placebo group.

Median event-free survival (time a patient lives without any disease-related occurrences, such as a recurrence/relapse or death) was also not met for patients given Keytruda, while it was 17 months in patients given a placebo.

Keytruda works by blocking the interaction between PD-1 and PD-L1/PD-L2, thereby allowing immune T cells to better find and destroy cancer cells.

No new safety signals were observed in KEYNOT-671, and the side effects observed were consistent with those seen in prior studies of the drug.

In KEYNOTE-671, the most common side effects reported in 20% or more of patients were nausea, fatigue, neutropenia, anemia, constipation, decreased appetite, white blood cell count decreased, musculoskeletal pain, rash, cough, vomiting, diarrhea and difficulty breathing. Of the patients who received presurgical treatment with Keytruda, 6% were unable to receive surgery due to side effects compared with 4.3% in the placebo group. Also, 3.1% of patients who received presurgical treatment and surgery in the Keytruda arm had delays in surgery because of side effects, compared with 2.5% in the placebo arm.

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