Patients with relapsed or refractory multiple myeloma (MM) who had relapsed after treatment with as many as 3 prior therapeutic agents may benefit from a new triple-therapy approach. Results from the open-label phase 3 CANDOR study were reported by Amgen.
In the study, researchers evaluated carfilzomib in combination with dexamethasone and daratumumab (KdD) in comparison with carfilozomib and dexamethasone alone (Kd). The 2 regimens were compared in 466 patients with relapsed or refractory MM who had received 1 to 3 prior therapies. Patients were treated until disease progression.
The primary end point was PFS; secondary end points included overall response rate, minimal residual disease, and overall surival. For this investigation, the researchers defined PFS as time from randomization until disease progression or death from any cause.
In one arm, patients received 56 mg/m2 carfilzomib twice weekly and dexamethasone in combination with daratumumab. In the second arm (control), patients received 56 mg/m2 carfilzomib twice weekly and dexamethasone.
KdD demonstrated a 37% reduction in risk for disease progression or death in patients with relapsed or refractory MM (hazard ratio [HR], 0.630; 95% CI, 0.464-0.854; P =.0014). Median PFS in patients treated with Kd alone was 15.8 months, whereas median PFS in patients treated with KdD had not been reached by the cutoff date.
A higher rate of adverse events (AEs) was reported with the 3-agent regimen compared with the 2-agent regimen. However, the observed AEs were consistent with the known safety profiles of the individual agents. In the triple-agent arm, the most frequently reported treatment-emergent AEs (incidence of 20% or more) were thrombocytopenia, anemia, diarrhea, hypertension, upper respiratory tract infection, fatigue, and dyspnea.
“The potential to combine [carfilzomib] with [daratumumab], 2 powerful targeted agents, represents an additional therapeutic approach for patients with relapsed or refractory MM,” said David M Reese, MD, executive vice president of research and development at Amgen. “The results from the CANDOR study confirm the potential for [carfilzomib] to be used in combination with an anti-CD38 monoclonal antibody.”
1. Amgen announces phase 3 CANDOR study combining KYPROLIS® (carfilzomib and DARZALEX® (daratumumab) meet primary endpoint of profression-free survival [press release]. Thousand Oaks, CA: Amgen; September 13, 2019.