Claire Li

TL;DR: It is suggested that weight-based and fixed-dose regimens are appropriate for pembrolizumab and high-weight patients had the lowest exposures with 200 mg Q3W; however, exposures in this group (>90 kg) were within the range of prior clinical experience at 2 mg/kgQ3W associated with near maximal efficacy.

TL;DR: Results support the use of the approved pembrolizumab dose of 2 mg/kg every 3 weeks without dose adjustment in a variety of patient subpopulations and demonstrate the model has robust power to detect clinically relevant covariate effects on clearance.

TL;DR: The results support the use of a 2 mg/kg Q3W dosage in patients with previously treated, advanced NSCLC and show the exposure-safety analysis showed the AE incidence to be similar among the clinically tested doses.

TL;DR: Overall results indicate that CL decreases over the treatment period of a typical patient in a pattern well described by a sigmoidal function of time with three parameters: the maximum proportion change in CL from baseline, the time to reach Imax/2 (TI50), and a Hill coefficient.

TL;DR: Chemotherapies have limited effectiveness and are associated with unfavorable toxicity profiles, highlighting a considerable unmet medical need for improved therapeutic options in mTNBC.