Belantamab mafodotin approved!
#mmsm #oncopharm
@SagarLonialMD
PI @ bit.ly/39YwDI6.
Clin pharm: BCMA directed ADC with MMAF maytansinoid payload (less neurotox vs MMAE)
Dose=2.5 mg/kg over 30 mins Q3 wk with art. tears QID throughout rx (avoid contact lenses)
1/
REMS for ocular AEs (blurred vision - sx in 22%, Gr 3/4 in 4%, other exam findings).
No exposure-response relationship (thus dose = 2.5 rather than 3.4).
Positive exposure-tox relationship (e.g., corneal AEs)
2/
PK: Accumulation = 70%
Slight reduction in CL over time
t1/2 @ SS = 14 days
No diff in PK on age (34-89), weight (42-130 kg), renal (30-89 mL/min).
Unknown re: < 30 mL/min - hard for me to see how CL of a MoAb and a hepatically cleared MMAF would be substantially diff
3/
DDI: MMAF substrate of OATB, MRP, and ? p-gp
Dose mod: hold for PLT < 25K, corneal (see PI).
Common AEs: > 20% keratopathy (corneal epithelium change on eye exam), decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.
4/
Grade 3/4: ≥5% platelets, lymphocytes, hemoglobin , neutrophils decreased; creatinine increased (disease confounding?), and GGT increased.
Infusion rxns in 18% (gr 3 = 1%). No premeds for all. If rxn, hold, slow rate, and rx for sx. Premed subsequently with directed agents.
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