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DREAMM-7 extended follow-up: BVd versus DVd in relapsed or refractory multiple myeloma after ≥1 prior line

Investigators reported that ocular events were managed with dose modifications and were generally reversible, alongside significant and clinically meaningful progression-free and overall survival benefits with BVd versus DVd; the authors describe BVd as a potential new standard of care in this setting.

  • Vania Hungria, MD; Paweł Robak, MD; Marek Hus, MD; Vera Zherebtsova, MD; Christopher Ward, MD; P Joy Ho, MBBS; et al.

  • July 15, 2025

  • The Lancet Oncology
  • The Lancet Oncology, Volume 26, Issue 8, Pages 1067–1080
  • 10.1016/S1470-2045(25)00330-4

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Evidence before this study

Patients with multiple myeloma often relapse after first-line triplet or quadruplet therapy, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies, highlighting the need for effective second-line treatment combinations that include therapies with novel mechanisms of action. B-cell maturation antigen (BCMA) is an established therapeutic target in relapsed or refractory multiple myeloma (RRMM). On the basis of a PubMed search using the terms “relapsed”, “myeloma”, ”BCMA”, and ”clinical trial” for studies published in English from Jan 1, 1990, to Feb, 14, 2025, multiple trials of BCMA-targeting chimeric antigen receptor T-cell and bispecific antibody therapies are ongoing. In addition, phase 1, 2, and 3 studies of belantamab mafodotin, a BCMA-targeting monoclonal antibody–drug conjugate, were identified. Belantamab mafodotin has shown promising antimyeloma activity and manageable safety as a single agent in heavily pretreated patients with RRMM (phase 1 DREAMM-1 [] and phase 2 DREAMM-2 []). In the confirmatory, randomised, phase 3 DREAMM-3 study (), belantamab mafodotin monotherapy did not reach statistical significance for superiority in median progression-free survival versus pomalidomide and dexamethasone, despite numerical benefit. Agents with differing mechanisms of action have dramatically improved outcomes in RRMM, and belantamab mafodotin showed preclinical synergy with other agents; therefore, belantamab mafodotin was combined with bortezomib and dexamethasone (BVd) and compared with daratumumab, bortezomib, and dexamethasone (DVd) in DREAMM-7, and belantamab mafodotin was combined with pomalidomide and dexamethasone and compared with pomalidomide, bortezomib, and dexamethasone in DREAMM-8 (). In the primary analyses, DREAMM-7 and DREAMM-8 showed a significant progression-free survival benefit and early positive trends for overall survival in favour of the belantamab mafodotin combinations compared with their respective comparators, with follow-up ongoing.

Added value of this study

To our knowledge, DREAMM-7 is the first phase 3, head-to-head study of a triplet regimen showing significant and clinically meaningful progression-free survival and overall survival benefits against an established anti-CD38-based triplet regimen in patients with RRMM after at least one previous line of therapy. BVd maintained durable and deep responses after extended follow-up, with greater than double the rates of complete response or better, minimal residual disease negativity rates, and median duration of response compared with DVd. Treatment benefits with BVd were also maintained after subsequent antimyeloma therapy. The overall safety profile of BVd was consistent with the DREAMM-7 primary analysis; ocular events, a known risk with belantamab mafodotin, were effectively managed with dose modifications and generally reversible with adequate follow-up, allowing patients to remain on treatment and continue to derive benefit.

Implications of all the available evidence

BVd is a potential new standard of care in patients with RRMM at first or later relapse, based on the manageable safety profile and significant and clinically meaningful overall survival, progression-free survival, minimal residual disease-negativity, and duration of response benefits compared with DVd.

Source: The Lancet Oncology

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