In an analysis from the phase III DREAMM-7 trial reported in The Lancet Oncology, Hungria et al compared survival outcomes with belantamab mafodotin, bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma (RRMM) who had received at least one line of prior therapy.
The primary analysis of the trial showed a significant progression-free survival benefit with BVd vs DVd at first interim analysis.
Study Details
In the global open-label trial, 494 patients were randomly assigned between May 2020 and June 2021 to receive BVd (n = 243) or DVd (n = 251). The current report provides results for overall survival at the second interim analysis and for other secondary endpoints.
Key Findings
At a median follow-up of 39.4 months (interquartile range = 14.6–42.9 months), death had occurred in 28% of patients in the BVd group vs 41% of patients in the DVd group; median overall survival was not reached (95% confidence interval [CI] = not reached to not reached) with BVd vs not reached (95% CI = 41.0 months to not reached) with DVd (hazard ratio [HR] = 0.58, 95% CI = 0.43–0.79, P = .0002).
For other secondary endpoints, patients in the BVd group had a higher measurable residual disease negativity rate among those with complete response or better (25% vs 10%) and a longer median duration of response (40.8 vs 17.8 months).
Among 87 patients in the BVd group and 130 in the DVd group who received subsequent antimyeloma therapy after disease progression, median progression-free survival-2 was not reached with BVd (95% CI = 45.6 months to not reached) vs 33.4 months (95% CI = 26.7–44.9 months) with DVd (HR = 0.59, 95% CI = 0.45–0.77).
Overall, treatment-related grade 3 or 4 adverse events occurred in 92% of those in the BVd group vs 67% of the DVd group, most commonly thrombocytopenia (56% vs 35%). Treatment-related serious adverse events occurred in 21% vs 13% of patients. Treatment-related deaths occurred in seven patients (3%) in the BVd group (pneumonia in four and gastrointestinal hemorrhage, subdural hemorrhage, and mesenteric vessel thrombosis in one each) and in two patients (1%) in the DVd group (COVID-19 infection in both).
The investigators concluded: “DREAMM-7 showed significant and clinically meaningful overall survival, progression-free survival, [measurable] residual disease negativity, and duration of response benefits with BVd vs DVd. BVd could be a new standard of care for [relapsed or refractory multiple myeloma].”
Maria-Victoria Mateos, MD, of Hospital Universitario de Salamanca/IBSAL/CIC/Ciberonc, Salamanca, Spain, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by GSK. For full disclosures of all study authors, visit thelancet.com.
