Final analysis results from DREAMM-3, a phase 3 study of belantamab mafodotin versus pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma - Scorecard - MDSpire
Clinical Scorecard: Final DREAMM-3 Phase 3 Findings: Belantamab Mafodotin Compared With Pomalidomide Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma
At a Glance
Category
Detail
Condition
Relapsed or refractory multiple myeloma (RRMM)
Key Mechanisms
Belantamab mafodotin is an anti-BCMA antibody-drug conjugate with a multimodal mechanism of action.
Target Population
Adults with multiple myeloma verified using IMWG criteria and at least two prior lines of therapy, including lenalidomide and a proteasome inhibitor.
The final descriptive analysis included 325 randomized patients and had a median follow-up of approximately 22 months in each treatment group.
Median PFS was 11.2 months with belantamab mafodotin and 7.0 months with pomalidomide-dexamethasone; the HR was 0.87 (95% CI, 0.64–1.18).
Median OS was 24.0 versus 22.9 months, respectively; the HR was 0.98 (95% CI, 0.73–1.30).
Median duration of response was 25.3 months with belantamab mafodotin and 9.9 months with pomalidomide-dexamethasone.
Grade 3–4 adverse events occurred in 71% and 66% of patients, respectively; blurred vision was reported in 48% versus 7%.
Guideline-Based Recommendations
Diagnosis
Trial eligibility required multiple myeloma verified using International Myeloma Working Group criteria.
Management
Participants were randomized 2:1 to single-agent belantamab mafodotin or pomalidomide-dexamethasone and continued treatment until progression, death, unacceptable toxicity, loss to follow-up, or study completion.
Treatment-emergent adverse events with belantamab mafodotin were generally managed with dose delays and/or reductions.
Ophthalmic examination findings were managed with dose delays and dose reductions.
Monitoring & Follow-up
The trial assessed investigator-assessed PFS using IMWG criteria, overall survival, response outcomes, adverse events, and ophthalmic examination findings.
Ophthalmic examination findings were graded by investigators or derived when investigator-assessed grades were unavailable.
Risks
At least one maximum Grade 3–4 adverse event occurred in 71% of belantamab mafodotin recipients and 66% of pomalidomide-dexamethasone recipients.
Blurred vision occurred in 48% with belantamab mafodotin and 7% with pomalidomide-dexamethasone.
Any-grade thrombocytopenia occurred in 35% and 34%, anemia in 29% and 34%, and neutropenia in 12% and 40%, respectively.
Patient & Prescribing Data
The final analysis included 325 patients: 218 assigned to belantamab mafodotin and 107 to pomalidomide-dexamethasone. Median age was 68 years; 22% were aged 75 years or older.
Median treatment duration was 4.5 months with belantamab mafodotin and 5.5 months with pomalidomide-dexamethasone. Among belantamab mafodotin recipients with available assessments, 80% of those with derived any-grade ophthalmic findings had Grade 2+ findings; 80% of patients with an initial Grade 2+ event had resolution to Grade 1 or better by data cutoff.
Clinical Best Practices
Assess ophthalmic examination findings during belantamab mafodotin treatment; the trial reports dose delays and reductions as management approaches.
Monitor adverse events, including ocular events, cytopenias, and reported liver enzyme or liver function abnormalities.
Interpret the final efficacy estimates as descriptive: no formal hypothesis testing was prespecified because the primary analysis had not met the superiority threshold.
