Trial Overview
- Design & Population
DREAMM-8 is a randomized, open-label Phase III trial comparing:- BPd arm: belantamab mafodotin (B-Pd) combined with pomalidomide and dexamethasone
- PVd arm: pomalidomide, bortezomib, and dexamethasone
It enrolled approximately 302 patients with RRMM who had prior lenalidomide exposure and documented progression, excluding those with prior BCMA-targeted therapy or bortezomib intolerance/refractoriness.
Key Findings
- Progression-Free Survival (PFS)
The BPd regimen demonstrated a significant PFS advantage. The 12-month PFS rate was 71% vs 51% in the PVd group (hazard ratio ~0.52) - Response Rates & Duration
- Overall Response Rate (ORR): 77% with BPd vs 72% with PVd
- Complete Response or Better: 40% vs 16% favoring BPd
- Median Duration of Response: Not reached for BPd, vs ~17.5 months for PVd
- Safety & Adverse Events
Ocular adverse events were notably more frequent with BPd (grade 3/4 in 43% vs 2%). Overall AE rates were high across both arms (>95%) but manageable
Clinical Significance
- These results mark a potential resurgence for belantamab mafodotin (Blenrep) in RRMM, especially following its market withdrawal after prior trial setbacks. Analysts are anticipating regulatory filings based on DREAMM-7/8 data to restore its role in treatment.