Effectiveness and safety of belantamab mafodotin in patients with relapsed or refractory multiple myeloma in real‐world setting: The ALFA study

Objectives The aim of this noninterventional, retrospective ALFA study was to describe belantamab mafodotin effectiveness and safety in patients with relapsed/refractory multiple myeloma in a real‐world setting in France. Methods Response rate, progression‐free survival (PFS), overall survival (OS), and safety were assessed. Results Among the 184 patients initiating belantamab mafodotin treatment, the overall response rate was 32.7% (≥very good partial response [VGPR] 20.4%, partial response [PR] 12.3%). The median PFS (mPFS) was 2.4 months (95% confidence interval [CI]: 1.9, 3.3), and median OS (mOS) was 8.8 months (95% CI: 6.3, 11.6). According to best response, mPFS was 20.6 months (95% CI: 12.1, not reached [NR]) in patients with ≥VGPR and 7.1 months (95% CI: 4.6, 9.4) in patients with PR; mOS was NR in patients with ≥VGPR and 17.5 months (95% CI: 7.7, NR) in patients with PR. For both OS and PFS, no differences were found in subgroups of interest. The adverse events (AEs) reported in 159 patients (86.4%) were mostly ocular AEs. Conclusions ALFA, the largest real‐world cohort conducted so far, confirms the results of belantamab mafodotin as reported in the DREAMM‐2 clinical trial. The clinical benefit is significant as long as the patient is a responder.