Patients with relapsed or refractory multiple myeloma treated with carfilzomib plus dexamethasone and daratumumab had improved progression-free survival compared with those treated with carfilzomib plus dexamethasone alone, according to results of the CANDOR study released by Amgen.
The median progression-free survival for the daratumumab-based combination was not yet reached compared with 15.8 months for carfilzomib plus dexamethasone alone. The combination of carfilzomib plus daratumumab resulted in a 37% reduction in risk for progression or death (hazard ratio [HR], 0.630; 95% CI, 0.464-0.854; P=.0014).
The phase 3 study randomly assigned 466 patients to carfilzomib twice weekly at 56 mg/m2 and dexamethasone in combination with daratumumab or the same dose of carfilzomib plus dexamethasone alone. Patients had received between 1 and 3 prior therapies.
There was a higher frequency of adverse events reported in patients assigned the 3-drug regimen compared with the 2-drug regimen. The most commonly reported treatment-emergent adverse events for carfilzomib plus daratumumab and dexamethasone 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,” Ajai Chari, MD, 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, said in a press release. “CANDOR confirms in a large Phase 3 study the benefit for patients demonstrated in the earlier Phase 1 study using the same combination.”
Full data from the study have not yet been presented or published.
Carfilzomib is approved by the US Food and Drug Administration in relapsed or refractory multiple myeloma as a single agent in patients who have received 1 or more prior lines of therapy, or in combination with dexamethasone or lenalidomide plus dexamethasone for patients who have received 1 to 3 prior lines of therapy.
Amgen. Amgen announces phase 3 CANDOR study combining Kyprolis (carfilzomib) and DARZALEX (daratumumab) meets primary endpoint of progression-free survival [press release]. Published September 13, 2019. Accessed September 24, 2019.