
Among patients with relapsed or refractory multiple myeloma (MM), treatment with belantamab mafodotin (belamaf), bortezomib, and dexamethasone (BVd) significantly improved survival versus standard of care with daratumumab, bortezomib, and dexamethasone (DVd), based on results from the phase III DREAMM-7 trial.
The study, led by María-Victoria Mateos, MD, PhD, of the Hospital Universitario de Salamanca in Spain, enrolled 494 patients with relapsed or refractory MM and one or more prior lines of therapy to receive either BVd (n=243) or DVd (n=251).
The primary endpoint was progression-free survival (PFS) as assessed by an independent review committee. Secondary endpoints included overall survival (OS), duration of response (DOR), and overall response rate (ORR).
At a median follow-up of 28.2 months (range, 0.10-40.00 months), the median PFS was 36.6 months (95% CI, 28.4 to not reached) with BVd versus 13.4 months (95% CI, 11.1-17.5) with DVd (hazard ratio [HR], 0.41; 95% CI, 0.31-0.53; P<.00001). The authors noted the OS data were 29% mature, and median OS was not reached in either arm (HR, 0.57; 95% CI, 0.40-0.80; nominal P<.0005).
The ORR in the BVd group was 82.7% (95% CI, 77.4-87.3) compared with 71.3% (95% CI, 65.3-76.8) in the DVd group, and the median DOR was 35.6 months (95% CI, 30.5 to not reached) with BVd versus 17.8 months (95% CI, 13.8-23.6) for DVd.
One or more adverse events (AEs) were observed in all patients. Grade 3/4 treatment-related AEs were reported in 90% of BVd patients versus 67% of DVd patients, and serious AEs were reported in 50% of BVd patients versus 37% of DVd patients. Additionally, 79% of the BVd group had ocular AEs compared with 29% of the DVd group, though events were manageable, according to the authors.
“These results support BVd as a potential new [standard of care] in this setting,” Dr. Mateos and colleagues wrote.
Reference
Mateos MV, Robak P, Hus M, et al. Results from the randomized phase III DREAMM-7 study of belantamab mafodotin (belamaf) + bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in relapsed/refractory multiple myeloma (RRMM). Abstract #439572. Presented at the ASCO® Plenary Series; February 6, 2024; Virtual. doi:10.1200/JCO.2024.42.36_suppl.439572