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K.L. Yong et al.
achieving an objective response (i.e., ≥partial response) at 24 weeks was higher for KCd than for VCd (84.0% vs. 68.1%, respectively), with a difference of 15.9% (90% CI: 6.8, 25.0). In logistic regression modeling of overall response at 24 weeks, the odds ratio was 2.72 (90% CI: 1.62, 4.55; P=0.0014). Subgroup analysis (Figure 3B) indi- cated broadly similar treatment effects across all sub- groups, except that patients not treated with ASCT and those relapsing within 12 months had particular benefit from carfilzomib (interaction P<0.05 for both).
Similar results were observed for ORR and VGPR with- in 12 months (Online Supplementary Table S2). Participants in the KCd arm had significantly longer time to maximum response (median 2.9 vs. 2.2 months for VCd: HR=0.74, 90% CI: 0.60, 0.92; P=0.0220). The median duration of
A
response was 11.1 months for KCd vs. 10.1 months for VCd (HR=0.87 and 90% CI: 0.64, 1.17; P=0.441).
MRD was assessed at 24 weeks in 157 samples that were received and evaluable, 121 for the KCd arm, and 46 for the VCd arm. For KCd, 22 (18.2%) participants were MRD negative, compared to six (13.0%) for VCd (OR=1.48, 90% CI: 0.64, 3.40) (Online Supplementary Table S3).
Progression-free survival, overall survival and time to next treatment
All participants in the analysis population were included in the inverse probability of censoring weighted PFS analysis (n=169 events in participants not weighted 0) (Online Supplementary Table S1). The median PFS in the
B
Figure 3. Forest plots of responses at 24 weeks after the initial randomization. The Forest plots show results of an analysis of (A) very good partial response and (B) overall response rate in pre-specified subgroups of the intention-to-treat population, at 24 weeks after the initial randomization. The odds ratio (OR) is provided from logistic regression modeling. NI: non-inferiority; CI: confidence interval; ASCT: autologous stem cell transplantation; 12m: 12 months; thal: thalidomide; len: lenalidomide; KCd: carfilzomib, cyclophosphamide, dexamethasone; VCd: bortezomib, cyclophosphamide, dexamethasone.
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haematologica | 2021; 106(10)