FDA approves Keytruda (pembrolizumab) for treatment of patients with resectable (T greater than 4 cm or N+) NSCLC in combination with chemotherapy as neoadjuvant treatment, then continued as a single agent as adjuvant treatment after surgery.- Merck Inc.
Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with resectable (tumors greater than 4 centimeters [cm] or node positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
With this approval, Keytruda has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.
The approval was based on data from the Phase III KEYNOTE-671 trial evaluating Keytruda in combination with chemotherapy as neoadjuvant treatment followed by surgery and continued adjuvant treatment with Keytruda as a single agent, for patients with resectable stage II, IIIA or IIIB (N2) NSCLC per the American Joint Committee on Cancer eighth edition (AJCC 8th edition).
In the study, the Keytruda regimen demonstrated statistically significant improvements in event-free survival (EFS) and overall survival (OS), the study’s dual primary endpoints, versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo alone. The EFS results, which were from the first interim analysis, were published in June 2023 in the New England Journal of Medicine (previously cited). The detailed OS results will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 20, 2023.
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