Abstract The randomized, phase 3 DREAMM-7 trial (NCT04246047) previously demonstrated the efficacy and safety of belantamab mafodotin, bortezomib, and dexamethasone (BVd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM) and ≥ 1 prior therapy. The results in the Japan expansion cohort of DREAMM-7, consisting of 24 patients randomized to receive BVd (N = 10) or DVd (N = 14), are presented here. The median follow-up was 19.4 months (range, 1.3–30.3). Median progression-free survival (PFS) was not reached (NR; 95% CI, 7.0–NR) with BVd versus 11.1 months (95% CI, 4.9–NR) with DVd (PFS hazard ratio, 0.40; 95% CI, 0.11–1.52). The overall response rate was 90.0% (95% CI, 55.5–99.7) versus 71.4% (95% CI, 41.9–91.6); median duration of response was NR (95% CI, 9.7–NR) versus 14.5 months (95% CI, 3.5–NR). Safety trends in the Japan expansion cohort were similar to those in the global cohort. Ocular adverse reactions were more common with BVd and were manageable with dose modification. No new safety signals were reported. As in the global cohort, results in the Japan expansion cohort demonstrated the safety and efficacy of BVd in patients with RRMM and ≥ 1 prior therapy.
Fujisaki et al. (2026) studied this question.