Real-world characteristics and outcomes of patients with multiple myeloma treated with belantamab mafodotin: a German claims data study

Ann Hematol. 2025 May 31. doi: 10.1007/s00277-025-06427-6. Online ahead of print.

Abstract

In the DREAMM-2 trial, belantamab mafodotin (belamaf) monotherapy demonstrated clinical activity and a manageable safety profile in pretreated patients with relapsed/refractory multiple myeloma (RRMM). Real-world evidence on this patient population is scarce. This study describes real-world baseline characteristics, ocular events, and time-to-event outcomes of patients with RRMM before, during, and after belamaf treatment between August 1, 2020, and March 31, 2023, in Germany based on anonymized health insurance claims data. In the overall cohort (N = 31), the median age was 66 years and all patients had received several MM therapies prior to treatment with belamaf. Of the patients included in the pre-belamaf (n = 31), belamaf (n = 31), and post-belamaf (n = 22) treatment periods, 10 (32.3%), 16 (51.6%), and 15 (68.2%) had at least one recorded ophthalmological visit, respectively. Keratitis was the most frequent among ocular diagnoses of interest across all three study periods. During the belamaf treatment period, seven (22.6%) patients had one or more incident ocular diagnoses of interest, the most frequent being corneal-related events. In the overall cohort, the real-world progression-free survival and overall survival were 4.3 months (95% confidence interval [CI] 2.4-7.7) and 12.3 months (95% CI 6.9-not evaluable), respectively. Our data emphasize the importance of ocular supportive care during belamaf treatment in real-world clinical practice. Our findings also highlight that RRMM remains an aggressive disease with a poor prognosis.

Keywords: Belamaf; Belantamab mafodotin; Ocular events; Real-world evidence; Relapsed/refractory multiple myeloma.