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Pembrolizumab in Combination With Pemetrexed and Carboplatin Granted FDA Approval as First-Line Treatment in Metastatic Nonsquamous NSCLC

On May 10, 2017, pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor, in combination with pemetrexed and carboplatin was granted approval by the U.S. Food and Drug Administration (FDA) in the first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC), irrespective of programmed cell death ligand 1 (PD-L1) expression. Continued approval of this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYNOTE-021 (cohort G1) is the study on which this approval is based. A total of 123 previously untreated patients with metastatic nonsquamous NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations were included.

In this trial, the three-drug combination therapy produced an objective response rate nearly double that of pembrolizumab/carboplatin alone (55% vs 29%), and all responses were partial responses. Furthermore, 93% of patients treated with the combination therapy had a duration of response of 6 months or more, compared with 81% of those who received pembrolizumab/carboplatin alone. An improvement in progression-free survival was also reported with the addition of pembrolizumab over the two-drug therapy, with a median progression-free survival of 13.0 months versus 8.9 months.