Research in context
Evidence before this study
Effective therapies with acceptable safety profiles are needed to improve outcomes of patients with relapsed or refractory multiple myeloma, particularly for patients with disease that is refractory to immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies, who have few treatment options available. Before initiating the DREAMM-1 study, we searched PubMed with the terms “relapsed”, “myeloma”, “BCMA”, and “clinical trial” for studies published from Jan 1, 1990, onwards. Although we identified multiple trials assessing B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor T-cell therapies and related adoptive cellular approaches, we found no published studies in humans of BCMA-targeting antibodies or immunoconjugates. Belantamab mafodotin (GSK2857916) is a first-in-class, anti-BCMA immunoconjugate with a multimodal mechanism of action. In the first-in-human, phase 1 DREAMM-1 study, belantamab mafodotin showed promising anti-myeloma activity, inducing responses in heavily pre-treated patients with relapsed or refractory multiple myeloma.
Added value of this study
DREAMM-2 builds on the results from DREAMM-1, showing that the responses observed with single-agent belantamab mafodotin at both the 2·5 mg/kg and 3·4 mg/kg doses (every 3 weeks) compare favourably with the responses described with other approved treatments in patients who were heavily pre-treated and refractory to immunomodulatory drugs and proteasome inhibitors and refractory or intolerant to anti-CD38 monoclonal antibodies (either alone or in combination). Results from DREAMM-2 also show that the safety profile of belantamab mafodotin is manageable, with no new safety concerns compared to DREAMM-1.
Implications of all the available evidence
Belantamab mafodotin might be a viable treatment option for patients with relapsed or refractory multiple myeloma, particularly those who are refractory to immunomodulatory drugs and proteasome inhibitors, and refractory or intolerant (or both) to anti-CD38 monoclonal antibodies as a single-agent treatment. Additional studies of belantamab mafodotin in combination with standard of care or novel agents are ongoing or planned.