Final analysis results from DREAMM-3, a phase 3 study of belantamab mafodotin versus pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma

Targeting B-cell maturation antigen (BCMA) has transformed the relapsed/refractory multiple myeloma (RRMM) landscape with unprecedented overall survival (OS) outcomes versus standard-of-care triplet regimens. Belantamab mafodotin, an anti-BCMA antibody-drug conjugate, has a multimodal mechanism of action involving minimal immunosuppression and no evidence of induction of T-cell exhaustion [ 1 , 2 ]. DREAMM-3 (NCT04162210) was a confirmatory phase 3 study to support the initial United States Food and Drug Administration and European Medicines Agency authorization of belantamab mafodotin monotherapy for patients with RRMM who had ≥4 prior lines of therapy (LOTs) [ 3 , 4 ]; approval was withdrawn following DREAMM-3 findings, as the primary endpoint of progression-free survival (PFS) superiority against the doublet comparator, pomalidomide-dexamethasone, was not met [ 5 , 6 , 7 ]. Subsequently, belantamab mafodotin combination regimens with bortezomib-dexamethasone (BVd) and pomalidomide-dexamethasone (BPd) have received approval for patients with RRMM who have received ≥1 prior LOT in multiple countries [ 8 ]. In the US, BVd was approved for patients with RRMM who have received ≥2 prior LOT [ 9 ].