The European Commission has granted conditional marketing authorisation for Blenrep ( Belantamab mafodotin ) as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Blenrep is a first-in-class humanised anti-BCMA ( B-cell maturation antigen ) treatment for these patients whose disease has progressed despite the current standard of care.
The approval is based on data from the pivotal DREAMM-2 ( DRiving Excellence in Approaches to Multiple Myeloma ) study, including 13-month follow-up data.
These data have demonstrated that treatment with single-agent Belantamab mafodotin, administered as a 2.5 mg/kg dose every three weeks ( Q3W ), resulted in an overall response rate of 32%. The median duration of response was 11 months and median overall survival was 13.7 months.
The safety and tolerability profile were consistent with previously reported data on Belantamab mafodotin.
The most commonly reported adverse events in the 2.5 mg/kg arm ( greater than or equal to 20% ) were keratopathy / microcyst-like epithelial changes or MECs ( 71% ), thrombocytopenia ( 38% ), anaemia ( 27% ), blurred vision events ( 25% ), nausea ( 25% ), pyrexia ( 23% ), increased aspartate aminotransferase ( AST ) ( 21% ), infusion-related reactions ( 21% ), and lymphopenia ( 20% ).
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF ( B-cell activating factor ) and APRIL ( a proliferation-inducing ligand ). This pathway has been shown to be important for myeloma cell growth and survival.
BCMA expression is limited to B cells at later stages of development.
BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.
Belantamab mafodotin is an antibody drug conjugate comprising a humanised anti-BCMA monoclonal antibody conjugated to the cytotoxic agent Auristatin F via non-cleavable linker.
There are approximately 48,000 new cases of multiple myeloma diagnosed each year across Europe. ( Xagena )
Source: GSK, 2020