Final Analysis of Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone in the CANDOR Study.

CANDOR (NCT03158688) is a phase 3, randomized, open-label trial comparing carfilzomib, daratumumab, and dexamethasone (KdD) versus carfilzomib and dexamethasone (Kd) in adults with relapsed/refectory multiple myeloma (RRMM) with 1-3 prior therapies. The CANDOR study met its primary endpoint of progression-free survival (PFS) in the primary analysis. Here we report the final analysis of the study, including secondary endpoints and subgroup analyses thereof. Median follow-up was 50 months. Patients treated with KdD had higher minimal residual disease-negative (MRD-) achievement rates (28% vs 9%; odds ratio [OR], 4.22 [95% CI, 2.28-7.83]) and MRD- complete response rates (22% vs 8%; OR, 3.55 [1.83-6.88]) than those treated with Kd. Median PFS was 28.4 months for KdD versus 15.2 months for Kd (hazard ratio [HR], 0.64 [95% CI, 0.49-0.83]). Median overall survival (OS) was 50.8 months versus 43.6 months, respectively (HR, 0.78 [0.60-1.03]; P=0.042). Trends toward improved OS occurred in predefined subgroups, including patients refractory to lenalidomide (KdD, not reached; Kd, 38.2 months; HR, 0.69 [0.43-1.11]) and refractory to proteasome inhibitor (KdD, 43.2 months; Kd, 30.0 months; HR, 0.70 [0.45-1.09]), and there was significant improvement in patients with high-risk cytogenetics (KdD, 34.3 months; Kd: 17.1 months; HR, 0.52 [0.29-0.94]). No new safety signals were identified. In summary, the final analysis of CANDOR confirmed the PFS benefit and showed a trend in OS benefit with KdD versus Kd. These findings reinforce KdD as a standard of care for RRMM, especially in clinically relevant patient subgroups.