MedPath

Belantamab mafodotin

Generic Name
Belantamab mafodotin
Brand Names
BLENREP
Drug Type
Biotech
Chemical Formula
-
CAS Number
2050232-20-5
Unique Ingredient Identifier
DB1041CXDG
Background

Belantamab mafodotin, or GSK2857916, is an afucosylated monoclonal antibody that targets B cell maturation antigen conjugated to the microtubule disrupter monomethyl auristatin-F (MMAF).

Belantamab mafodotin was granted FDA accelerated approval on 5 August 2020 for the treatment of multiple myeloma; however, its manufacturer began the process for withdrawal of the US marketing authorization in November 2022. In the meantime, belantamab mafodotin will be available for patients in the Risk Evaluation and Mitigation Strategy (REMS) program who can enrol in a compassionate use program.

Indication

Belantamab mafodotin is indicated in the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

Associated Conditions
Relapsed/Refractory Multiple Myeloma (RRMM)
Associated Therapies
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BPd Maintains QOL vs PVd, Supporting Its Use as a New SOC in R/R Myeloma

DREAMM-8 trial showed BPd (belantamab mafodotin-blmf, pomalidomide, dexamethasone) was generally well-tolerated and maintained HR-QOL over time in relapsed/refractory multiple myeloma patients compared to PVd (bortezomib, pomalidomide, dexamethasone). BPd led to more significant improvements in physical functioning and fatigue, supporting its potential as a new standard of care.
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The GEM-BELA-VRD trial showed 94% ORR with belantamab mafodotin-blmf, bortezomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma patients, with CR rates improving from 36% to 82% over treatment phases. MRD-negative rates increased from 60.9% to 91.2%. High-risk patients achieved 100% MRD-negative status post-consolidation. PFS rates were 90% at 12 months and 85% at 24 months, with OS rates of 92% and 85% respectively. Ocular toxicity was the main adverse effect, with manageable outcomes.
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