European journal of haematology · 2024
Effectiveness and safety of belantamab mafodotin in patients with relapsed or refractory multiple myeloma in real-world setting: The ALFA study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Roussel Murielle, Texier Nathalie, Nael Virginie, Bitetti Jacopo, Paka Prani, Kerbouche Naima, Sail Lynda, Colin Xavier, Leleu Xavier
Аннотация
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.
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.