Phase 3 CANDOR Trial Confirms Triplet Regimen Improves PFS for R/R MM

Final analysis results of the phase 3 CANDOR study were released to confirm the improved efficacy and safety of carfilzomib, daratumumab, and dexamethasone over carfilzomib plus dexamethasone in patients with relapsed or refractory (R/R) multiple myeloma.

“Despite recent advances in therapeutic options, there remains an unmet need for treating patients with R/R MM, especially in those previously exposed or refractory to lenalidomide,” explained Saad Usmani, MD, Levine Cancer Institute, North Carolina, and co-researchers.

A total of 466 patients with R/R MM were enrolled to the randomized, open-label trial and were stratified by disease stage, previous proteasome inhibitor or anti-CD38 antibody exposure, and number of prior regimen exposures. In all, 312 patients received the triplet regimen and 154 patients received carfilzomib plus dexamethasone.

All patients received intravenous infusion of carfilzomib twice per week at 56 mg/m². Daratumumab 8 mg/kg was given intravenously on days 1 and 2 of cycle 1, and at 16 mg/kg weekly for the remaining doses of the first 2 cycles, then every 2 weeks for 4 cycles, and every 4 weeks thereafter. Patients also received 40 mg dexamethasone weekly (20 mg for patients ≥ 75 years old).

The primary endpoint of the trial was progression-free survival (PFS).

“At data cutoff, the median follow-up time was 27.8 months with the triplet regimen, and 27 (months) for carfilzomib plus dexamethasone. Median PFS was 28.6 months in the triplet regimen group, and 15.2 months in the carfilzomib plus dexamethasone group,” continued Dr Usmani and co-authors.

Grade ≥ 3 treatment-emergent adverse events (TEAEs) occurred in 268 patients (87%) from the triplet regimen group versus 116 (76%) in the doublet group. The most common TEAEs were thrombocytopenia (25% versus 16%, respectively), hypertension (21% vs 15%), pneumonia (18% vs 9%), and anemia (17% vs 15%). No treatment-related deaths were reported.

“A clear, maintained PFS benefit of carfilzomib, daratumumab, and dexamethasone over carfilzomib plus dexamethasone with longer follow-up was confirmed, making this triplet regimen and emerging standard-of-care for patients with R/R MM,” concluded Dr Usmani, et al.—Alexa Stoia

Usmani, S, Quach H, Mateos M, et al. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): updated outcomes from a randomised, multicentre, open-label, phase 3 study. News release. The Lancet Oncology; January 1, 2022. Accessed February 9, 2022.