Keytruda, Alimta and carboplatin for lung cancer – pro
On May 10, 2017 the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda), an antiprogrammed cell death protein 1 (PD-1) therapy, in combination with pemetrexed (Alimta) and carboplatin for the first-line treatment of metastatic nonsquamous nonsmall cell lung cancer (NSCLC), irrespective of programmed death-ligand 1 (PD-L1) expression. Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival (PFS) and may be revised once OS data becoems available.
The approval was based on data from the KEYNOTE-021 trial, Cohort G1, in 123 previously untreated patients with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations and irrespective of PD-L1 expression. In this trial, pembrolizumab plus pemetrexed/carboplatin demonstrated an objective response rate (ORR) that was nearly double the ORR of pemetrexed/carboplatin alone: 55% (95% confidence interval [CI] = 4268) compared to 29% (95% CI = 1841), respectively; all responses were partial responses.
Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators.. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508
Keytruda, Prescribing Information 2017