Summary

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• This summary is based on the review of two randomized controlled trials. ^[1-2]
• Blenrep (belantamab mafodotin-blmf) is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
• In adults with RRMM, belantamab mafodotin, bortezomib, and dexamethasone (BVd) showed longer median Progression-Free Survival (PFS) (36.6 months [95% Confidence interval (CI), 28.4 to not reached]) than daratumumab, bortezomib, and dexamethasone (DVd) (13.4 months [95% CI, 11.1 to 17.5]), with a Hazard Ratio (HR) for disease progression or death of 0.41 (95% CI, 0.31 to 0.53; P<0.001). OS at 18 months was 84% with BVd vs. 73% with DVd, and the HR for death at the second interim analysis was 0.58 (95% CI, 0.43-0.79; P=0.0002).
• BVd was associated with greater response durability, including favored restricted mean response duration (P<0.001) and higher rates of complete response or better plus Minimal Residual Disease (MRD)-negative status (25% vs. 10%).
• Median Progression-Free Survival on Next-Line Therapy (PFS2) was not reached for BVd (95% CI, 45.6 months to not reached) vs. 33.4 months for DVd (95% CI, 26.7 to 44.9), with an HR for PFS2 of 0.59 (95% CI, 0.45-0.77).
• Grade ≥ 3 Adverse Events (AEs) occurred in 95% (BVd) vs. 78% (DVd); ocular events occurred in 79% (BVd) vs. 29% (DVd); thrombocytopenia was the most common grade 3–4 AE (56% BVd vs. 35% DVd); serious AEs occurred in 53% (BVd) vs. 38% (DVd), with pneumonia (12% vs. 4%), pyrexia (5% vs. 4%), and COVID-19 (5% vs. 4%) as the most common serious AEs.
• Treatment-related serious AEs leading to death occurred in 3% of BVd patients (pneumonia, gastrointestinal hemorrhage, subdural hemorrhage, mesenteric vessel thrombosis) vs. 1% of DVd patients (COVID-19).
• Adults with RRMM had a median age of 64.5 years (IQR 57.0–71.0), 55% were male, 83% were White, all had Eastern Cooperative Oncology Group (ECOG) 0–2 and ≥ 1 prior therapy, and enrollment spanned 142 centers across 20 countries. Subgroup analyses by age, gender, ethnicity, or prior treatment lines were not detailed.