FDA Expands Approval of Pembrolizumab for First-Line Treatment of NSCLC
Posted: Thursday, July 12, 2018
The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC).
This new approval of pembrolizumab was based on the results of the phase II KEYNOTE-021 (ClinicalTrials.gov identifier NCT02039674) trial of 123 patients with advanced or metastatic nonsquamous NSCLC without mutations in the EGFRgene or alterations in the ALKgene, for which there are existing targeted therapies. Patients in the trial had not been treated previously and were randomly assigned to receive either pembrolizumab plus chemotherapy or chemotherapy alone.
In the trial, 55% of the patients who received pembrolizumab and chemotherapy had at least a partial response to treatment, compared with 29% of patients who received chemotherapy alone. The median progression-free survival for the groups was 13 months vs. 8.9 months, respectively.
The most common severe side effects among patients who received pembrolizumab with chemotherapy included fatigue, dyspnea, and nausea. The initial results from a phase III trial with an expected enrollment of 570 patients are expected within the next year.
