Fig 1.
KEYNOTE-555 cohort B CONSORT flow diagram.
PK, pharmacokinetics. aMaximum serum concentration (Cmax) or trough serum concentration (Ctrough) or both.
Table 1.
Baseline demographics and disease characteristics.
Fig 2.
Best percentage change from baseline in target lesions as per RECIST v1.1 by BICRa.
BICR, blinded independent central review; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1. aIncludes patients with baseline and postbaseline target lesion assessment. *Indicates patient had progressive disease in non-target lesions.
Fig 3.
Kaplan-Meier estimate of progression-free survival as per RECIST v1.1 by BICR.
BICR, blinded independent central review; NR, not reached; PFS, progression-free survival; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1.
Table 2.
Objective response as per RECIST v1.1 by BICR.
Fig 4.
Observed pharmacokinetic data from patients treated with pembrolizumab 400 mg Q6W in cohort B of KEYNOTE-555 compared with (A, B) the model-predicted pharmacokinetic profile for pembrolizumab 400 mg Q6W (median and 90% prediction interval); (C, D) the model-predicted Ctrough for pembrolizumab 200 mg Q3W, 2 mg/kg Q3W, and 400 mg Q6W; (E, F) and the model predicted Cmax for pembrolizumab 2 mg/kg Q3W, 200 mg Q3W, 400 mg Q6W, and 10 mg/kg Q2W. The green dots are the observed pharmacokinetic data from patients treated with pembrolizumab 400 mg Q6W in cohort B of KEYNOTE-555. Cmax, maximum serum concentration; Ctrough, trough serum concentration; Q3W, every 3 weeks; Q6W, every 6 weeks.
Table 3.
Summary of adverse events.
Table 4.
Treatment-related adverse events occurring in ≥5% of patients.