Belantamab gets approval as a fourth-line therapy for multiple myeloma

August 7, 2020 0 By FM

Belantamab mafodotin (Blenrep) has been recently approved by the US FDA as a fourth-line therapy in treating adult patients with relapsed or refractory multiple myeloma, announced GlaxoSmithKline.

Belantamab mafodotin (blmf) monotherapy is an anti-BCMA (B-cell maturation antigen) therapy that can be used in patients who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.

Multiple myeloma is the second most common blood cancer and is generally considered treatable, but not curable. There are numerous multiple myeloma treatments but some patients become resistant to those drugs considered standard of care. When their cancer relapses, they are often re-treated with drugs from the same class, which lowers the probability of a patient responding.

Hence, BCMA, which is a cell-surface protein that plays an important role in the survival of plasma cells and is expressed on multiple myeloma cells, becomes an important therapeutic target.

The approval of blmf was based on six-month primary results from the pivotal DREAMM-2 study, which enrolled patients with relapsed or refractory multiple myeloma who had actively progressing disease that had worsened despite the current standard of care.

The findings from the trial showed that treatment with single-agent bmlf 2.5 mg/kg every three weeks demonstrated a clinically meaningful overall response rate (ORR) of 31% (97.5% CI; 21-43) in patients who had received a median of seven prior lines of treatment (n=97).

About 73% of responders had a duration of response (DoR) equal to or greater than six months. The most commonly reported adverse events (≥20%) were keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.

Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population and included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%).