Two relatively newer therapies (carfilzomib and daratumumab) have now been combined with dexamethasone in the Phase III CANDOR study and showed a 37% reduction in the risk of myeloma progression or death for relapsed or refractory myeloma patients treated with the triplet combination.
The CANDOR study evaluated 466 relapsed or refractory myeloma patients who had received one to three prior lines of therapy. The study had two arms – carfilzomib/daratumumab/dex (KdD) vs. carfilzomib and dex (Kd) alone. The study was first evaluating progression free survival and key secondary points of review were overall response rate, minimal residual disease and overall survival.
The median progression free survival for the Kd combination was 15.8 months, where the median progression free survival for the KdD combination has not yet been reached by the study cut-off date.
This study confirms the potential for carfilzomib and daratumumab to be combined in myeloma treatments.
“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 3 study the benefit for patients demonstrated in the earlier Phase 1 study using the same combination.”
There was a higher frequency of adverse events reported in the KdD arm compared to the Kd arm. 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 shortness of breath.
Relapsed myeloma patients or those who have become resistant to therapies are always in need of more treatment options, and this combination is a welcome addition.
We can expect to learn more about the CANDOR study outcomes at upcoming meetings, most likely at ASH 2019 in Orlando.