pembrolizumab alone (n=151) vs. brentuximab vedotin (n=153)
randomized controlled trial
pembrolizumab
pembrolizuma intravenously at200 mg every 3 weeks
brentuximab vedotin
Brentuximab vedotin wasadministered intravenously at 1·8 mg/kg every 3 weeks(maximum 180 mg per dose)
Dose modifications werenot permitted for pembrolizumab, but were permittedfor brentuximab vedotin
R/R cHL - second line or more (L2)
open label
78 hospitals and cancer centres in 20 countries and territories
P3/ one sided and 4 interim analysis. The full statistical analysis plan specified four interimanalyses and a final analysis. Overall type I error acrossthe testing of overall survival, primary progression-freesurvival, and frequency of objective response hypotheseswas strongly controlled at 2·45% (one-sided).
Treatment with pembrolizumab resulted in a statistically and clinically significant improvement in progression-free survival compared with brentuximab vedotin in adults patients with relapsed or refractory classical Hodgkin lymphoma (interim analysis results)