7.6-month increase in median OS1
*47.6 months (Kd) vs 40.0 months (Vd); hazard ratio (Kd/Vd) = 0.791 (95% CI: 0.648-0.964); one-sided P = 0.01
9.3-month increase in median PFS2
18.7 months (Kd) vs 9.4 months (Vd); hazard ratio (Kd/Vd) = 0.53 (95% CI: 0.44-0.65); one-sided P < 0.0001
CI = confidence interval; Kd = KYPROLIS® (carfilzomib) and dexamethasone; OS = overall survival; PFS = progression-free survival; Vd = VELCADE® (bortezomib) and dexamethasone.
The Kd vs Vd OS results have not yet been reviewed by FDA, and inclusion in the final, FDA-approved label for KYPROLIS® has yet to be determined.
SEE Kd RESULTS
†Kd vs Vd study: A phase 3, randomized, open-label, multicenter superiority study compared KYPROLIS® plus dexamethasone (Kd) to VELCADE® plus dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 lines of therapy. 929 patients were randomized to a 1:1 ratio to receive Kd (n = 464) for 28-day cycles or Vd (n = 465) for 21-day cycles until disease progression or unacceptable toxicity occurred. Patient stratification included prior proteasome inhibitor therapy (either VELCADE® or KYPROLIS®, or no prior therapy), prior lines of therapy (1 vs 2 or 3), International Staging System stage (1 vs 2 or 3), and planned route of VELCADE® administration, if randomized to the VELCADE® group (intravenous vs subcutaneous). The primary endpoint was progression-free survival (PFS). Select secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DoR), and safety. The significance level of the pre-planned OS second interim analysis is determined by the O’Brien-Fleming type alpha spending function based on the number of OS events observed by the analysis time.1-4