Dr Sidana on the FDA Approval of Belantamab Mafodotin Plus Vd in R/R Myeloma

“My one message to any provider that is going to adapt [belantamab mafodotin for use in their practice] is to not be scared of dose delays and dose reduction. Dose reduce at the first sight of any blurred vision or dry eye, because I think it's very important that you know this is a major toxicity that we need to be cognizant of.”

Surbhi Sidana, MD, a medical oncologist at Stanford Medicine, discussed the clinical significance of the FDA approval of belantamab mafodotin-blmf (Blenrep) in combination with bortezomib (Velcade) and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 2 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD). The approval was supported by results from the phase 3 DREAMM-7 trial (NCT04246047).

In DREAMM-7, BVd significantly improved overall survival (OS) and progression-free survival (PFS) compared with daratumumab (Darzalex), bortezomib, and dexamethasone (DVd). Among patients who had received at least 2 prior lines of therapy, BVd reduced the risk of death by 51% (HR, 0.49; 95% CI, 0.32-0.76). The median OS was not reached (NR; 95% CI, NR-NR) with BVd compared with 35.7 months (95% CI, 21.2-NR) with DVd. The median PFS was 31.3 months (95% CI, 23.-–NR) in the BVd arm vs 10.4 months (95% CI, 7.0-13.4) with DVd (HR, 0.31; 95% CI, 0.21-0.47). The safety profile of BVd was consistent with the known toxicities of the individual agents.

Sidana highlighted the clinical value of this approval, noting that belantamab mafodotin is a B- BCMA-targeted antibody-drug conjugate that can be administered in the community setting. This expands access to BCMA-directed therapy for patients who may not be eligible for or able to access CAR T-cell therapy or bispecific therapies, Sidana noted.

Sidana emphasized that the data from DREAMM-7 demonstrated meaningful clinical activity for the belantamab mafodotin–based regimen. However, ocular toxicity remains a key consideration. Corneal adverse effects, including keratopathy, were observed in approximately 80% of patients treated with BVd, with grade 3 or 4 effects reported in approximately 30% of patients. Sidana stressed the importance of proactive dose holds, reductions, and early ophthalmologic evaluation for any visual changes to prevent severe complications.