The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) of belantamab mafodotin (GSK2857916; GlaxoSmithKline) for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Belantamab mafodotin is a humanized, afucosylated, IgG1 anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent, monomethyl auristatin F. The application is supported by data from the phase 2, two-arm, open-label trial (DREAMM-2) that assessed the efficacy and safety of belantamab mafodotin in 196 patients with relapsed or refractory multiple myeloma after 3 or more lines of therapy that included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Patients were randomized 1:1 to receive belantamab mafodotin 2.5mg/kg (n=97) or 3.4mg/kg (n=99) via intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. The primary end point was the overall response rate, defined as the proportion of patients with a confirmed partial response (PR) or better.
Results demonstrated that patients in the 2.5mg/kg and 3.4mg/kg cohorts achieved overall response rates of 31% (97.5% CI, 20.8-42.6) and 34% (97.5% CI, 20.8-42.6), respectively, according to a recently published study in The Lancet Oncology.
With regard to safety, the most common grade 3-4 adverse events reported in the 2.5mg/kg and 3.4mg/kg cohorts were keratopathy (27% [n=26] and 21% [n=21]), thrombocytopenia (20% [n=19] and 33% [n=33]), and anemia (20% [n=19] and 25% [n=25]), respectively.
The FDA previously granted Breakthrough Therapy designation to belantamab mafodotin.
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