belantamab mafodotin   Click here for help

GtoPdb Ligand ID: 11117

Synonyms: belamaf [4] | belantamab mafodotin-blmf | Blenrep® | GSK-2857916 | GSK2857916
Approved drug Immunopharmacology Ligand
belantamab mafodotin is an approved drug (FDA & EMA (2020))
Compound class: Antibody
Comment: Belantamab mafodotin (GSK2857916) is a humanised BCMA-targeting antibody-drug conjugate that is in clinical development for multiple myeloma. Mafodotin is the cytotoxic, synthetic antineoplastic monomethyl auristatin F (MMAF; PubChem CID 56841603). Belantamab mafodotin is an IgG1 class antibody so, in addition to its delivery of a cytotoxin, it is predicted to exhibit lytic activity (through complement binding) and/or induce antibody-dependent cell cytotoxicity (ADCC). GlaxoSmithKline claim anti-BCMA ADCs in patent US9273141B2 [1]. SEQ IDs 55 and 63 from US9273141B2 match the full-length heavy chain and light chain sequences respectively, that were submitted to the WHO for the belantamab mafodotin INN.
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Summary of Clinical Use Click here for help
Belantamab mafodotin (GSK2857916) was progressed to clinical evaluation in relapsed/refractory MM trials as a monotherapy and in combinations with other antineoplastics. The EMA granted belantamab mafodotin orphan designation in October 2017, for the treament of MM [2]. The FDA granted belantamab mafodotin (Blenrep) accelerated conditional approval in August 2020 for patients with relapsed/refractory MM. Eligible patients were those who had received prior treatment with ≥4 therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. However, the FDA's conditional marketing authorisation was rescinded in November 2022, when belantamab mafodotin treatment failed to show superiority in terms of progression-free survival compared to standard of care (pomalidomide and dexamethasone) in the DREAMM-3 confirmatory clinical trial NCT04162210.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT02064387 Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 Phase 1 Interventional GlaxoSmithKline 6-7
NCT03525678 A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody Phase 2 Interventional GlaxoSmithKline 3
NCT04162210 Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) Phase 3 Interventional GlaxoSmithKline DREAMM-3 comfirmatory study.
NCT04246047 Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma Phase 3 Interventional GlaxoSmithKline The DREAMM-7 trial.
NCT04484623 Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma Phase 3 Interventional GlaxoSmithKline The DREAMM-8 trial.