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Combination prolongs PFS in relapsed or refractory myeloma
The addition of daratumumab to carfilzomib and dexamethasone extended PFS for patients with relapsed or refractory multiple myeloma, according to topline results from the randomized phase 3 CANDOR study.
Carfilzomib (Kyprolis, Amgen) is a proteasome inhibitor, and daratumumab (Darzalex, Janssen) is a human monoclonal antibody that targets CD38. Both agents are approved in the United States for treatment of certain patients with multiple myeloma.
The CANDOR study included 466 patients with relapsed or refractory myeloma who had received one to three prior therapies.
Researchers assigned patients to carfilzomib twice weekly at 56 mg/m2 and dexamethasone with or without daratumumab. Treatment continued until disease progression.
PFS served as the primary endpoint. Key secondary endpoints included overall response rate, minimal residual disease and OS.
Patients assigned the three-agent regimen demonstrated a 37% reduced risk for progression or death (median PFS, not reached vs. 15.8 months; HR = 0.63; 95% CI, 0.46-0.85).
“The potential to combine Kyprolis and Darzalex — two powerful targeted agents — represents an additional therapeutic approach for patients with relapsed or refractory multiple myeloma,” David M. Reese, MD, executive vice president of research and development at Amgen, said in a company-issued press release. “The results from the CANDOR study confirm the potential for Kyprolis to be used in combination with an anti-CD38 monoclonal antibody.”
Researchers reported a higher frequency of adverse events in the carfilzomib-daratumumab-dexamethasone group. The most frequently reported treatment-emergent events in that group were thrombocytopenia, anemia, diarrhea, hypertension, upper respiratory tract infection, fatigue and dyspnea.
“[Although] 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 and director of clinical research in the multiple myeloma program at Mount Sinai, said in the 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 results from the CANDOR study will be submitted for presentation at a future medical meeting. Healio.com will publish more detailed results when they are available.