Keynote 189 trial#
Keynote 189 license#

1,2 Data from the phase 1 KEYNOTE-001 and phase 3 KEYNOTE-010 studies indicated that patients with advanced NSCLC and a PD-L1 tumor proportion score of 50% or greater were more likely than those with lower tumor proportion scores to have a response to pembrolizumab, a highly selective, humanized monoclonal antibody against programmed death 1 (PD-1) that prevents PD-1 from engaging PD-L1 and PD-L2. (Funded by Merck KEYNOTE-024 number, NCT02142738.) IntroductionĪpproximately 23 to 28% of patients with advanced non–small-cell lung cancer (NSCLC) have a high level of programmed death ligand 1 (PD-L1) expression, which is defined as membranous PD-L1 expression on at least 50% of tumor cells, regardless of the staining intensity (i.e., a PD-L1 tumor proportion score of 50% or greater). In patients with advanced NSCLC and PD-L1 expression on at least 50% of tumor cells, pembrolizumab was associated with significantly longer progression-free and overall survival and with fewer adverse events than was platinum-based chemotherapy. 90.0% of patients), as were grade 3, 4, or 5 treatment-related adverse events (26.6% vs. 6.3 months ), and treatment-related adverse events of any grade were less frequent (occurring in 73.4% vs. 27.8%), the median duration of response was longer (not reached vs. The response rate was higher in the pembrolizumab group than in the chemotherapy group (44.8% vs.

The estimated rate of overall survival at 6 months was 80.2% in the pembrolizumab group versus 72.4% in the chemotherapy group (hazard ratio for death, 0.60 95% CI, 0.41 to 0.89 P=0.005). Median progression-free survival was 10.3 months (95% confidence interval, 6.7 to not reached) in the pembrolizumab group versus 6.0 months (95% CI, 4.2 to 6.2) in the chemotherapy group (hazard ratio for disease progression or death, 0.50 95% CI, 0.37 to 0.68 P<0.001). Secondary end points were overall survival, objective response rate, and safety. The primary end point, progression-free survival, was assessed by means of blinded, independent, central radiologic review. Crossover from the chemotherapy group to the pembrolizumab group was permitted in the event of disease progression. In this open-label, phase 3 trial, we randomly assigned 305 patients who had previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene to receive either pembrolizumab (at a fixed dose of 200 mg every 3 weeks) or the investigator’s choice of platinum-based chemotherapy. Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non–small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1).

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Keynote 189 license#

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Keynote 189 trial#

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