Phase III CANDOR study of Kyprolis + Darzalex + dexamethasone meets primary endpoint of progression-free survival for multiple myeloma

Amgen announced the Phase III CANDOR study evaluating Kyprolis (carfilzomib) in combination with dexamethasone and Darzalex (daratumumab) (KdD) compared to Kyprois and dexamethasone alone (Kd) met its primary endpoint of progression-free survival (PFS). The regimen resulted in a 37% reduction in the risk of progression or death in patients with relapsed or refractory multiple myeloma treated with KdD (HR=0.630; 95% CI: 0.464, 0.854; p=0.0014). The median PFS for patients treated with Kd alone was 15.8 months, while the median PFS for patients treated with KdD has not been reached by the cut-off date.

There was a higher frequency of adverse events reported in KdD, a three-agent regimen, than in Kd, a two-agent regimen. The types of observed adverse events were consistent with the known safety profiles of the individual agents. The most frequently reported treatment-emergent adverse events (greater than or equal to 20%) in the KdD arm were thrombocytopenia, anemia, diarrhea, hypertension, upper respiratory tract infection, fatigue and dyspnea.

"While treatment advances have improved outcomes for patients with multiple myeloma, there remains a need for additional therapeutic options for patients who have relapsed," said Ajai Chari, M.D., associate professor of medicine, the director of clinical research in the Multiple Myeloma Program and the associate director of clinical research, Mount Sinai Cancer Clinical Trials Office. "CANDOR confirms in a large Phase III study the benefit for patients demonstrated in the earlier Phase 1 study using the same combination."

The CANDOR data will be submitted to a future medical meeting and discussed with health authorities in preparation for regulatory submissions.

CANDOR, a randomized, open-label Phase III study of Kyprolis, dexamethasone and Darzalex (KdD) compared to Kyprolis and dexamethasone (Kd), has evaluated 466 relapsed or refractory multiple myeloma patients who have received one to three prior therapies. Patients were treated until disease progression. The primary endpoint was PFS, and the key secondary endpoints were overall response rate, minimal residual disease and overall survival. PFS was defined as time from randomization until disease progression or death from any cause. In the first arm, patients received Kyprolis twice weekly at 56 mg/m2 and dexamethasone in combination with Darzalex. In the second arm (control), patients received Kyprolis twice weekly at 56 mg/m2 and dexamethasone. CANDOR was initiated as part of a collaboration with Janssen, and under the terms of the agreement, Janssen co-funded the study. For more information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT03158688.