Insight on the role of isatuximab and VRd in patients with newly diagnosed multiple myeloma following data from the GMMG-HD7 study.
Ajay K. Nooka, MD, MPH, FACP: GMMG-HD7 study is a German study that evaluated the benefit of the addition of isatuximab [Sarclisa] to the standard regimen of VRd [bortezomib (Velcade), lenalidomide (Revlimid), dexamethasone] backbone. So, the study, again randomized close to 660 patients to receive RVd, which is a standard of care arm, similar to the GRIFFIN study.
And here, the experiment lab is the addition of isatuximab to RVd backbone. The primary end point for this study is next-generation flow testing of MRD [minimal residual disease] negativity and the sensitivity of 10-5.
So again, the differences between [the] GRIFFIN study and this specific study, GMMG-HD7, [the] GRIFFIN study, the primary end point is [a] stringent complete response after 6 cycles, both as induction, as well as consolidation with a transplant sandwiched between. GMMG-HD7 study included the primary end point of MRD negativity by NGF [nerve growth factor] at 10-5 post-induction treatment.
When you compare both of these studies, I would not want people to be comparing apples to oranges, and that’s the reason why I’m explaining the differences between these studies. The primary end points are different. The number of cycles that the patients receive are different.
And here, the primary end point is MRD negative 10-5, which is seen in 50% of the patients that are receiving the isatuximab plus VRd, and the comparator arm had the MRD negativity at 10-5 seen in 35% of the patients.
If you look at the depths of responses, rather than VGPR [very good partial response], [they] were seen in 77% of the patients after 4 cycles of isatuximab plus VRd and the comparator arm had the depth of response of VGPR at 60.5%. So, this is a good study, again showing the benefit of the addition of a CD38 monoclonal antibody.
Again, both the studies showed exactly the same concept that we are discussing. [That] the addition of the fourth agent, which is a CD38 monoclonal antibody, is safe. Number 2, it is able to deliver those deeper responses at MRD negative rates to be significantly higher than what the standard of care is used in the United States.
Transcript edited for clarity.