346 patients were assigned to the daratumumab arm, and 344 to the control group. During the first 9 cycles, 19.4% of patients discontinued treatment in the daratumumab arm, compared with 33.1% in the control group. Discontinuations were more frequent in the control group due to progressive disease (6.6% v 13.3%) and adverse events (4.9% v 9.3%).
The median PFS was not reached (NR) in the daratumumab group, compared with 18.1 months in the control group (p<0.001). 18 month PFS was 71.6% versus 50.2%. Superiority of daratumumab was seen across all subgroups, including poor risk patients based on age, stage, and cytogenetics.r
© NEJM 2018
© NEJM 2018
Overall response rate was 90.9% in the daratumumab arm v 73.9% in the control group (p<0.001). Similarly rates of complete response were higher in the experimental arm (42.6% v 24.4%, p<0.001).
The data was recently updated at ASH2018, with an additional 12 months of follow-up.r Now with median follow-up of 27.8 months, median PFS remained significantly improved in the daratumumab arm (NR v 19.1 months, p<0.0001). Median PFS to next line of treatment (PFS2) was also higher in the daratumumab arm (NR v NR, p=0.0013).