Belantamab Mafodotin Tops Daratumumab in Multiple Myeloma


Belantamab mafodotin plus a combination of bortezomib and dexamethasone improved median progression-free survival (PFS) by 23 months in patients with relapsed or refractory multiple myeloma compared with daratumumab alongside the same combination.


  • Belantamab mafodotin, a first-in-class anti-BCMA monoclonal antibody conjugate, was approved in the US in 2020 for adult patients with relapsed or refractory multiple myeloma who had received at least 4 prior therapies. However, in February 2023, the FDA withdrew this approval, following disappointing findings from a large confirmatory trial, called DREAMM-3. Although the agent is still being investigated to treat relapsed or refractory multiple myeloma, the current FDA label says the agent is only available in the US through a restricted program.
  • Patients with multiple myeloma who relapse often become refractory to frontline triplet or quadruplet regimens and need effective second-line options.
  • In the current phase 3 DREAMM-7 study, the researchers evaluated triplet therapy with belantamab mafodotin vs daratumumab as a second-line or later treatment option in patients with relapsed or refractory multiple myeloma.
  • In this multicenter, open-label, randomized, phase 3 trial, 494 patients with relapsed/refractory multiple myeloma who previously received at least one prior line of therapy received bortezomib plus dexamethasone with either belantamab mafodotin or daratumumab.
  • The primary outcome was PFS; secondary endpoints were overall survival, duration of response, and overall response rate.


  • At a median follow-up of 28.2 months, patients who received belantamab mafodotin demonstrated significantly longer median PFS than those who received daratumumab (36.6 vs 13.4 months; hazard ratio [HR], 0.41). The improvement was evident in all prespecified groups, including patients refractory to lenalidomide (HR, 0.37) and those with a high risk for cytogenetic abnormalities (HR, 0.36).
  • The early overall survival trend favored belantamab mafodotin — with 84% of patients alive at 18 months vs 73% in the daratumumab group — but overall survival follow-up is ongoing.
  • The overall response rate was 83% in the belantamab mafodotin group vs 71% in the daratumumab group. Complete response rates were also higher in the belantamab mafodotin: 34.6% vs 17.1%. Median duration of response was twice as long in the belantamab mafodotin group (36 vs 18 months).
  • Grade 3 or higher non-ocular adverse events in belantamab mafodotin vs daratumumab group included thrombocytopenia (55% vs 35%), infections and infestations (31% vs 20%), neutropenia (12% vs 6%), pneumonia (12% vs 4%), and anemia (8% vs 10%). Grade 3 or higher ocular adverse events were reported in 34% of patients treated with belantamab mafodotin, but ocular toxicities reversed in most patients.


Based on favorable PFS and manageable safety profile, belantamab mafodotin in combination with bortezomib plus dexamethasone has potential to become a new standard of care in the second line or later among patients with relapsed or refractory multiple myeloma, the author concluded.


This study, led by Maria-Victoria Mateos, MD, PhD, from University Hospital of Salamanca, Salamanca, Spain, was presented at ASCO Plenary Series: February 2024 Session and published in the Journal of Clinical Oncology.


Open-label design was a limitation of this study. Follow-up for overall survival was ongoing.


This study was funded by GSK. Mateos reported receiving honoraria, consulting/personal fees outside this work.

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