This is DREAMM-2 an ongoing global, open-label, phase 2 study of single-agent belantamab mafodotin, a B-cell maturation antigen-targeting antibody-drug conjugate, in a frozen-liquid presentation in patients with relapsed/refractory multiple myeloma (RRMM).
Alongside the main study, following identical inclusion/exclusion criteria, a separate patient cohort was enrolled to receive belamaf in a lyophilized presentation until disease progression/unacceptable toxicity. The primary outcome was independent review committee-assessed ORR. Twenty-five patients were enrolled; 24 received ≥1 dose of belamaf. As ORR was 52%; 24% of patients achieved a very good partial response. The median duration of response was 9.0 months; median progression-free survival was 5.7 months; median overall survival was not reached. The most common grade 3/4 adverse events were keratopathy (microcyst-like corneal epithelial changes, a pathological finding seen on eye examination, thrombocytopenia, anemia, hypercalcemia and hypophosphatemia, neutropenia, and blurred vision.
The study concluded that pharmacokinetics supported the comparability of frozen-liquid and lyophilized presentations. Single-agent belamaf in a lyophilized presentation showed a deep and durable clinical response and acceptable safety profile in patients with heavily pre-treated RRMM.