Multinational phase 3 trial of belantamab mafodotin, pomalidomide, and dexamethasone in multiple myeloma

The multinational phase 3 DREAMM-8 trial randomized lenalidomide-exposed relapsed or refractory multiple myeloma (RRMM) to belantamab mafodotin, pomalidomide, and dexamethasone (BPd) or pomalidomide, bortezomib, and dexamethasone (PVd). The primary endpoint was progression-free survival. The 12-months PFS rate was 71% with BPd versus 51% with PVd (HR 0.52; p<0.001). Overall survival data were immature. Partial response or better was seen in 77% of BPd patients and 72% of PVd patients, and complete response in 40% and 16%, respectively. Grade 3 or higher adverse events occurred in 94% of patients in the BPd group and 76% of those in the PVd group. Ocular events occurred in 89% of patients in the BPd group and 30% in the PVd group. Ocular events in the BPd group were managed with belantamab mafodotin dose modification. Ocular events led to treatment discontinuation in 9% of the patients in the BPd group and none of the patients in the PVd group. The authors conclude that among lenalidomide-exposed RRMM patients, BPd conferred a significantly greater benefit than PVd with respect to PFS as well as deeper, more durable responses.