ASCO 2024 | Findings from DREAMM-7 establish belantamab mafodotin as a new SoC for R/R multiple myeloma

DREAMM-7 is a phase three randomized clinical trial conducted in relapsed refractory multiple myeloma patients after at least one prior line of therapy, in which balantamab mafodotin in combination with bortezomib and dexamethasone, has been compared with daratumumab in combination with bortezomib and dexamethasone. 494 patients were included in this study. Baseline characteristics of the patients were well balanced, and the primary endpoint was progression free survival.

And the primary endpoint was met, and balantamaf in combination with Vd resulted into a statistically significant and clinically meaningful prolongation of the progression free survival in comparison with the dara-Vd; median for bela-Vd 36.6 months versus 14 months for dara-Vd, with a hazard ratio of 0.4. This superiority was indeed sustained across the different pre-specified subgroup of patients remarking the efficacy in patients with the disease refractory to lenalidomide or patients with high risk cytogenetic abnormalities. This superiority was also observed in a clear trend to benefit also in overall survival, overall response rate, CR rate was the double for bela-Vd, as well as the minimal residual disease negativity rate. Safety profile was acceptable and according to the well known safety profile for each of the compounds, keratopathy was the most relevant adverse event in relation with the administration of belamaf. But it was manageable and it was reversible. And with those modifications and those delays, the rate of discontinuation was only 9%. Quality of life was comparable, and I would say that the final conclusion is bela-Vd can result in a new standard of care for relapsed refractory myeloma patients after at least one prior line of therapy.