The FDA has approved belantamab mafodotin-blmf as a treatment for patients with relapsed/refractory multiple myeloma who have received 4 prior therapies, including an immunomodulatory drug (IMiD), a proteasome inhibitor, and an anti-CD38 antibody.
B-cell maturation antigen (BCMA) is an established target for the treatment of multiple myeloma, and Balantamab is a BCMA targeting antibody – drug conjugate with diverse mechanisms of anti-tumor activity.
It is an off the shelf, BCMA targeted product joining bispecific antibodies Teclistamab and elranatamab.
Tradename Blenrep.
The DREAMM-2 trial, which showed that belantamab mafodotin elicited an overall response rate (ORR) of 31% in patients with relapsed/refractory multiple myeloma who received the treatment at the recommended 2.5 mg/kg dose.
In patients who received belantamab mafodotin at 3.4 mg/kg, the ORR was 34%.
Overall, the median duration of response (DOR) was not reached.
The median PFS was 2.9 months and 4.9 months in the 2.5-mg/kg and 3.4-mg/kg cohorts, respectively.
Compared with daratumumab, bortezomib and dexamethasone (DVd), Belantamab, bortezomib ,dexamethasone (BVd) conferred a significant benefit with respect to progression free survival among patients who had relapsed or refractory multiple myeloma after at least one line of therapy (DREAMM-7 TRIAL).
DREAMM-8 among patients with relapse to refractory myeloma BVd among lenalidomide exposed patients with relapsed or refractory myeloma conferred significant greater benefit than PVD (Pomalidomide, bortezomib, dexamethasone) with respect to progression free survival as well as deeper, more durable responses: Ocular events were more common in the BVd trial.
Decrease visual acuity to 20/50 or worse has been reported in 34% of patients who received this drug.
Dose modifications, and longer treatment free intervals can lead to improvement in visual acuity in nearly all affected patients with recovery to baseline in most patients and with low discontinuation due to ocular events.
Adverse events included: keratopathy, thrombocytopenia and anemia.
2.5 mg/kg is the recommended dose.