Daratumumab plus bortezomib and dexamethasone improves progression-free survival compared with bortezomib and dexamethasone alone in patients with relapsed or relapsed and refractory multiple myeloma, according to a study published in The New England Journal of Medicine.1
For the phase 3 trial, researchers enrolled 498 patients with relapsed or relapsed and refractory multiple myeloma and randomly assigned them to receive bortezomib 1.3 mg/m2 plus dexamethasone 20 mg with or without daratumumab 16 mg/kg.
The addition of daratumumab to bortezomib and dexamethasone significantly improved the 12-month progression-free survival and median progression-free survival (not reached vs 7.2 months; hazard ratio [HR], 0.39; 95% CI, 0.28-0.53; P <.001).
The overall response rate was 82.9% in the daratumumab group compared with 63.2% in the control group (P <.001). The rates of complete response or better (P =.001) and very good partial response or better (P <.001) were also significantly higher in the immunotherapy arm.
In terms of safety, the most common grade 3 to 4 treatment-related adverse events were thrombocytopenia, anemia, and neutropenia. Nearly half of all patients treated with daratumumab reported infusion-related reactions, which were mostly grade 1 to 2 and occurred during the first infusion.
Daratumumab, a human IgGκ monoclonal antibody that targets CD38, has exhibited substantial efficacy as monotherapy in heavily pretreated patients, and in combination with bortezomib in patients with newly diagnosed multiple myeloma.
A supplemental Biologics License Application for daratumumab, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone, has been submitted to the US Food and Drug Administration to expand the current indication to patients who have received at least 1 prior therapy.
1. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2016; 375:754-766.