Twelve-month maintenance data from this study demonstrate the survival and response benefits associated with daratumumab, noted Mark Wildgust, PhD, vice president of Global Medical Affairs/Oncology at Janssen.
Twelve-month maintenance data from this study demonstrate the survival and response benefits associated with daratumumab, especially the 81% rate of complete response and 51.4% rate of minimal residual disease negativity, noted Mark Wildgust, PhD, vice president of Global Medical Affairs/Oncology at Janssen.
What will the newest GRIFFIN trial results add to our knowledge of daratumumab’s benefit in multiple myeloma?
We've known before from the CASSIOPEIA trial, which was a study using daratumumab [dara] plus VTD [Velcade/thalidomide/dexamethasone], that when we add dara to that induction regimen, we improve the depth of response. We saw that in terms of the CR [complete response] rate and also MRD [minimal residual disease] negativity. We also saw a significant improvement in progression-free survival [PFS], too. And that CASSIOPEIA study led to the approval for daratumumab to be used with dara/VTD in induction.
However, [we have] our phase 3 PERSEUS study coming, which is the phase 3 version of GRIFFIN. But GRIFFIN really gives us those insights in terms of what do we see when we use dara plus VRD [Velcade/Revlimid/daratumumab] instead of VTD. So really using Revlimid instead of thalidomide.
Now we've reported out the primary results from GRIFFIN before, where we saw a significant improvement in the CR rate. We also saw higher rates of MRD negativity as well. But here at ASH [American Society of Hematology annual meeting] with the GRIFFIN study, we're now reporting the 12-month maintenance data. So if you remember the design of the trial, it's dara plus VRD, followed by transplant, followed by 2 cycles of dara/VRD, and then patients go on to a maintenance regimen of dara/lenalidomide, and in the control arm, it's just lenalidomide. And what we've seen now at 12 months is that, again, we see that significantly higher rate of depth of response. And we see an 81% rate of CR or better at 12 months vs 60.8% when we look at the VRD regimen.
So we're seeing that significant improvement in depth of response, and we're also seeing a significantly higher rate of MRD negativity as well when we look at those results. So we're looking at 51% vs 20.4%. So I think those, again, continue to show that when we add dara, we improve the rate of response in terms of the CR rate improving the MRD negativity. And at a 24-month mark, we're seeing a PFS rate of 95% with dara/VRD vs 91% with VRD.
So I think this really gives us confidence that [by] adding dara to that initial induction consolidation regimen and the maintenance, we do significantly improve overall response and depth of response. And we're excited now to see the PERSEUS study read out in the future.