Belantamab mafodotin (belamaf), bortezomib, and dexamethasone vs daratumumab, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma: updated 4-year results of the phase 3 DREAMM-7 trial
Advancements in relapsed/refractory multiple myeloma (RRMM) treatment with BCMA-targeted agents have revolutionized outcomes; however, an unmet need remains for broadly accessible therapies. Belamaf is a BCMA-targeting antibody-drug conjugate that can be given in the outpatient setting; in combination with bortezomib and dexamethasone (BVd), belamaf has demonstrated significant improvement in progression-free survival (PFS) and overall survival (OS) vs daratumumab, bortezomib, dexamethasone (DVd) in patients with RRMM.
Materials and Methods/Case Presentation/Objective:
DREAMM-7 (NCT04246047) is a phase 3, open-label, randomized trial evaluating the efficacy and safety of belamaf vs daratumumab with Vd backbones in patients with RRMM. The primary endpoint was independent review committee-assessed PFS. Secondary endpoints included OS, response rates, and safety. Here, we assess the long-term benefit of BVd vs DVd in patients with ≥1 prior line of therapy (intention-to-treat [ITT]) as well as a subgroup of patients with ≥2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent (3L+). The data cutoff for this descriptive analysis was Jan 9, 2026.
Results/Description/Main Outcome Measure(s):
At >4 years of follow-up in the ITT population (median, 52.9 months), BVd (n=243) maintained continued OS benefit vs DVd (n=251) [HR, 0.62; 95% CI, 0.46-0.82]. In 3L+ (BVd, n=108; DVd, n=109), OS also favored BVd (HR, 0.49; 95% CI, 0.33-0.74) with consistent findings in investigator-assessed PFS (HR, 0.39; 95% CI, 0.27-0.55) and PFS2 (HR, 0.51; 95% CI, 0.36-0.73). In the ITT population and the 3L+ subgroup, complete response or better was achieved in 38% and 35% of BVd-treated patients, respectively, compared with 21% and 12% of those treated with DVd. Median duration of response in 3L+ with BVd was 30.5 months (95% CI, 23.5-49.0) vs 13.9 months (10.4-17.3) with DVd. No new safety concerns emerged. Adverse event (AE) incidence remained consistent with previous analyses, with no new fatal AEs, and infection rates were unchanged. HRQOL remained stable over time, underscoring the long-term tolerability following switch to belamaf monotherapy after 8 cycles.
Conclusion(s).: With >4 years of follow-up, BVd OS benefit was maintained vs DVd. The overall safety profile remained consistent with the known profile of belamaf. These results, along with the convenience of outpatient administration, support BVd as a potential new standard-of-care therapy in RRMM at first relapse or later.
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