KYPROLIS® + dexamethasone
Superior efficacy in a proteasome inhibitor for deeper more durable responses1
Kd vs Vd study design (ENDEAVOR): Phase 3, randomized, open-label superiority study: (N=929) comparing Kd 56 mg/m2 twice weekly to Vd in relapsed or refractory multiple myeloma patients who had received 1 to 3 prior lines of therapy. The primary endpoint was PFS. Select secondary endpoints included OS, ORR, DoR, and safety.1,2
47.6 months with Kd (n=464) vs 40 months with Vd (n=465)
(HR=0.79; 95% CI: 0.65-0.96; P=0.01, one-sided)2
Higher ORR and deeper responses seen with Kd vs Vd2
Kd = carfilzomib + dexamethasone; mPFS = median progression-free survival; Vd = bortezomib + dexamethasone; HR= hazard ratio; CI = confidence interval; ORR = overall response rate; VGPR = very good partial response; CR = complete response.
Kd Patient Profile*
Meet Alice, a frail, standard risk patient with multiple myeloma at first relapse
*Hypothetical patient profile.
Kd vs Vd in RRMM (ENDEAVOR)
Phase 3, randomized, open-label superiority study: (N=929) comparing Kd 56 mg/m2 twice weekly to Vd in relapsed or refractory multiple myeloma patients who had received 1 to 3 prior lines of therapy. The primary endpoint was PFS. Select secondary endpoints included OS, ORR, DoR, and safety.1,2
Key eligibility criteria (N = 929):
Key exclusion criteria:
*Patient stratification included prior proteasome inhibitor therapy (either bortezomib or carfilzomib, 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 bortezomib administration, if randomized to the bortezomib group (intravenous vs subcutaneous).2
†NYHA classification of heart failure III is defined as: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea (shortness of breath). IV is defined as: Unable to carry out any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Kd = carfilzomib and dexamethasone; Vd = bortezomib and dexamethasone. R = randomization; mg/m2 = milligrams per meter squared body surface area; BIW = twice a week; mg = milligram; PFS = progression free survival; OS = overall survival; ORR = overall response rate; DoR = depth of response; MM = multiple myeloma; ECOG PS = Eastern Cooperative Oncology Group performance status; PR = partial response; PI = proteasome inhibitor; LVEF = left ventricular ejection fraction; CrCI = creatinine clearance; NYHA = New York Heart Association.
Kd = carfilzomib + dexamethasone.
References: 1. Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomized, phase 3, open-label, multicentre study. Lancet Oncol. 2016;17(1):27-38. 2. KYPROLIS® (carfilzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary.