The DREAMM-7 trial has revealed that belantamab mafodotin (Blenrep; GSK) in combination with bortezomib (Velcade; Millennium/Takeda, Janssen Pharmaceutical Companies) and dexamethasone (BVd) provides a clinically significant overall survival (OS) benefit for patients with relapsed or refractory multiple myeloma (RRMM) in the second line setting. The multicenter, open-label, randomized, phase 3 trial demonstrated a marked reduction in the risk of death compared to treatment with daratumumab (Darzalex; Johnson & Johnson), bortezomib, and dexamethasone (DVd). These findings offer a potential new treatment option for patients facing this challenging disease.
Trial Design and Patient Population
The DREAMM-7 trial enrolled 494 patients with RRMM who had progressed after at least one prior line of therapy. Participants were randomized 1:1 to receive either BVd (n=243) or DVd (n=251). Belantamab mafodotin was administered intravenously at 2.5mg/kg every three weeks. The primary endpoint was progression-free survival (PFS), with secondary endpoints including OS, duration of response, minimal residual disease (MRD) negativity rate, safety, and quality-of-life outcomes.
Significant Improvement in Progression-Free and Overall Survival
At a median follow-up of 28.2 months, the median PFS was 36.6 months (95% confidence interval [CI], 28.4 to not reached) in the BVd group, compared to 13.4 months (95% CI, 11.1 to 17.5) in the DVd group (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). The BVd regimen also demonstrated superior OS, with 84% of patients in the BVd group alive at 18 months compared to 73% in the DVd group. Furthermore, a complete response or better with MRD-negative status was achieved in 25% of patients in the BVd group and 10% in the DVd group.
Safety Profile and Adverse Events
Regarding safety, the majority of adverse events (AEs) were grade 3 or higher, occurring in 95% of patients in the BVd group and 78% in the DVd group. Ocular events were more prevalent in patients receiving BVd (79%) versus DVd (29%). However, dose modifications were effective in managing these AEs, suggesting that the benefits of the BVd regimen can be realized with careful monitoring and management of side effects.
Implications for Multiple Myeloma Treatment
These data suggest that the belantamab mafodotin, bortezomib, and dexamethasone combination offers a valuable treatment option for patients with relapsed/refractory multiple myeloma. The significant improvements in PFS and OS, along with manageable safety concerns, position BVd as a potential new standard of care in the second-line setting. This is particularly important given the heterogeneity of multiple myeloma and the need for a diverse range of therapeutic strategies to combat this challenging malignancy.
