Richard Pazdur, MD
The approval was based on data from the phase I KEYNOTE-001 trial, in which the overall response rate with the drug was 41% (n = 25) among a subgroup of 61 patients with pretreated PD-L1-–positive advanced NSCLC as determined by the 22C3 pharmDx diagnostic test. Response duration ranged from 2.1 to 9.1 months. A survival improvement has yet to be demonstrated in a clincial trial, and the acclerated approval is contingent upon the eventual outcomes of confirmatory studies. Click here to read the full article at OncLive.com.