The PERSEUS trial is a large prospective randomised study which included transplant eligible patients with multiple myeloma. They were randomised to receive either the standard VRd high-dose therapy, VRd consolidation and lenalidomide maintenance, or the investigational arm which included daratumumab both in induction, consolidation and maintenance. The main endpoint was progression free survival and the study showed there was a very significant improvement of PFS in favour of the daratumumab arm.
Furthermore, a prespecified analysis included the correlation of cytogenetics with progression free survival and response and we saw that for patients who had high-risk cytogenetics there was a significant improvement of their outcome when they received the daratumumab-based combination. The improvement was not complete, still patients without high-risk cytogenetics did better, but definitely there was an improvement as compared with VRd alone.
What could be the clinical impact of these results?
The clinical impact of these observations is that now we have a more effective regimen for patients with high-risk cytogenetics, including patients with 1q abnormalities. Of course, we need to improve the results for this particular subset of patients but definitely it is an improvement over the previous standard of care.