Primary objective met in the DREAMM-2 trial of belantamab mafodotin in relapsed/refractory multiple myeloma

On 23rd August 2019, headline results from the pivotal DREAMM-2 open-label, two-arm, randomized, phase II study of belantamab mafodotin (NCT03525678) were released.1 Belantamab mafodotin is an investigational anti-B-cell maturation antigen (BCMA) antibody-drug conjugate and the DREAMM-2 trial investigated the safety and efficacy at two doses in 196 patients with relapsed or refractory (R/R) multiple myeloma (MM) who had received more than three prior treatments, failed an anti-CD38 antibody and were refractory to a proteasome inhibitor and an immunomodulatory drug.

DREAMM-2 met its primary endpoint demonstrating a clinically meaningful overall response rate (ORR) and the safety profile was consistent with that observed in the preceding phase I trial - DREAMM-1.1

The results from DREAMM-2 will form the basis of regulatory submission for belantamab mafodotin, which is expected by the end of 2019.

Currently there are ongoing studies which are investigating belantamab mafodotin as third-line monotherapy in R/R MM and as a combination therapy in first- and second-line treatment.

References
  1. GlaxoSmithKline. GSK announces positive headline results from the pivotal DREAMM-2 study for multiple myeloma. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-headline-results-from-the-pivotal-dreamm-2-study-for-multiple-myeloma/ [Accessed August 27 2019]
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