Chari and colleagues presented results of a 4-arm, open-label, multicenter, phase 1b study that evaluated the safety and efficacy of the anti-CD38 monoclonal antibody daratumumab in combination with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma.1 The study population (n = 98) had received a median of 4.0 (2-13) prior therapies; 98% of patients were refractory to bortezomib, 32% to carfilzomib, 89% to lenalidomide, and 67% to both a proteasome inhibitor and immunomodulatory drug. Of the 38 patients who discontinued study treatment, 19 (50%) were due to progressive disease and 8 (21%) were due to adverse events (AEs). Daratumumab-specific infusion-related reactions occurred in 52 patients, and included chills (14%), cough (11%), and dyspnea (11%). Grade 3/4 AEs were mostly hematologic, including neutropenia, anemia, leukopenia, and thrombocytopenia; nonhematologic grade 3/4 AEs included dyspnea, hypertension, and fatigue. Seventeen deaths were reported. In the 75 patients who had >1 postbaseline assessments, an overall response rate (ORR) of 53% was achieved, including 4 stringent complete responses, 3 complete responses, 25 very good partial responses, and 21 partial responses. Patients also achieved greater depth of response over time. In the cohort of patients with double-refractory disease, an ORR of 67% was achieved. The 6-month progression-free survival was 66%. Based on these results, the authors concluded that the addition of daratumumab to Pom/Dex resulted in high response rates, greater depth of responses, without unexpected or exacerbating known toxicities.
- Chari A, et al. ASH 2015. Abstract 508.