The follow-up for these patients was quite long, so these patients were well into maintenance therapy. With that in mind, 81% of patients experienced infection at some point. Most of [these infections were of the] upper respiratory tract, but [no events were] worse than grade 3 in severity.
We were most excited about the efficacy data. After induction therapy, 94% of the patients responded to treatment and 56% of patients had at least a VGPR. We only had 6% CRs at the end of induction, but the ORR was 100%; all patients had a VGPR. In the maintenance setting, 15 out of 16 patients had either a CR or sCR. There was also interest about whether or not frontline daratumumab would negatively impact stem cell mobilization at the time of transplant. We did look at this and saw that this was not the case.
What this all tells us is that this is a very promising regimen. [However], I do want to emphasize the fact that this [analysis] only [looked at] 16 patients, and, in fact, three-fourths of them had stage I disease. We have to be a bit cautious about the infection signal. I would encourage physicians to not use this as their standard of care at this point. We are hopeful that we can provide phase II data in 2019.
What are the take-home messages from this research?
The main takeaway is, [in terms of safety profile, adding] daratumumab to VRd is what you would expect; there were no surprises with regard to AEs. We can also safely say that stem cell mobilization was not impacted. The responses seem very promising and it is evident that responses deepen over time. This is potentially a regimen that can change practice in the future.
Voorhees PM, Rodriguez C, Reeves B, et al. Efficacy and updated safety analysis of a safety run-in cohort from Griffin, a phase 2 randomized study of daratumumab (dara), bortezomib (V), lenalidomide (R), and dexamethasone (D; dara‐vrd) vs. vrd in patients (pts) with newly diagnosed (ND) multiple myeloma (MM) eligible for high‐dose therapy (HDT) and autologous stem cell transplantation (ASCT). In: Proceedings from the 2018 ASH Annual Meeting; December 1-4, 2018; San Diego, CA. Abstract 151. ash.confex.com/ash/2018/webprogram/Paper113122.html.