Treatment with belantamab mafodotin-blmf (Blenrep) plus pomalidomide (Pomalyst) and dexamethasone (BPd) improved rates of minimal residual disease (MRD) negativity sustained for at least 12 months compared with pomalidomide, bortezomib (Velcade), and dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma, according to a long-term update from the phase 3 DREAMM-8 trial (NCT04484623) presented at the
At a data cutoff of July 7, 2025, and a median follow-up of 35.8 months, the updated median progression-free survival (PFS) in the intention-to-treat (ITT) population was 32.6 months with BPd (n = 155) vs 12.5 months with PVd (n = 147; HR, 0.49; 95% CI, 0.36-0.67).
In the ITT population, the complete response (CR) or better rates were 64.2% for BPd vs 36% for PVd. CR or better with MRD negativity at a sensitivity threshold of 10-5 was reported in 27.7% of patients treated with BPd vs 6.1% of those treated with PVd. MRD negativity sustained for at least 12 months occurred in 15.5% of patients in the ITT population treated with BPd vs 2.7% of those treated with PVd. Among those who achieved CR, MRD negativity was sustained for at least 12 months by 55.8% of patients in the BPd arm (n = 43) vs 44.4% of patients in the PVd arm (n = 9).
“Patients treated with BPd who achieved sustained MRD negativity had features consistent with disease in earlier lines of therapy…suggesting that earlier use in the disease course contributes to deeper and more durable responses,” Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens in Athens, Greece, and colleagues wrote in a poster presentation of the data.
Notably, belantamab mafodotin is
DREAMM-8 was a phase 3, open-label, randomized trial evaluating BPd vs PVd in patients with relapsed/refractory multiple myeloma who received at least 1 prior line of therapy, including lenalidomide (Revlimid).1
A total of 302 patients were enrolled between October 2020 and December 2022. Patients in the BPd arm received belantamab mafodotin at 2.5 mg/kg intravenously in cycle 1, followed by 1.9 mg/kg every 4 weeks from cycle 2 onward, plus pomalidomide and dexamethasone.
The primary end point was PFS by independent review committee per International Myeloma Working Group criteria; key secondary end points included overall survival, CR or better, MRD negativity, and duration of response. MRD was assessed with a next-generation sequencing–based assay at a threshold of 10-5 by a central laboratory once patients reached a very good partial response or better, and was repeated every 6 months until disease progression. Sustained MRD negativity was defined as CR or better with MRD negativity maintained for at least 12 months.
Regardless of treatment arm, patients with sustained MRD negativity experienced longer PFS and time to second progression (PFS2) than those without sustained MRD negativity.
For patients in the BPd arm, the median PFS for those with sustained MRD negativity (n = 24) was NR (95% CI, NR-NR) vs 21.1 months (95% CI, 15.0-28.4) for those without sustained MRD negativity (n = 131). The respective PFS2 values for these groups were NR (95% CI, NR-NR) and 20.2 months (95% CI, 13.9-24.0).
In the control arm, the median PFS and PFS2 were both NR (95% CI, NR-NR) for those with sustained MRD negativity (n = 4). In those without sustained MRD negativity (n = 142), these respective rates were 10.2 months (95% CI, 8.6-16.0) and 9.2 months (95% CI, 7.4-11.9).
