Expert discusses the patient-reported outcomes from the GRIFFIN trial at the final study analysis after all patients completed 1 year of follow-up post maintenance therapy.
Pharmacy Times® interviewed Ajai Chari, MD, director of clinical research, Multiple Myeloma Program, Mt Sinai Cancer Clinical Trials Office, on the poster presentation titled “Health-Related Quality of Life in Transplant-Eligible Patients with Newly Diagnosed Multiple Myeloma Treated with Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone: Patient Reported Outcomes from GRIFFIN” at the 64th American Society of Hematology (ASH) Annual Meeting and Exhibition in New Orleans, Louisiana.
Pharmacy Times®: What are the implications of the GRIFFIN trial results for clinical practice?
Ajai Chari: The addition of daratumumab I think is now supported not just from a single arm study, but from a randomized study. And even though the primary endpoint was the depth of response, we actually saw also PFS benefit, and that seemed to favor almost all groups. So I think the addition of daratumumab is now an evidence-based treatment for frontline myeloma in the US.
Some practitioners really want randomized phase 3, those are the later adopters. But personally, I think the data are quite compelling. If the Cassiopeia study across the Atlantic Ocean, which was Dara VTd versus VTd, showed improved response, PFS and OS, we have now 2 different datasets that are supporting the use of quadruplet induction.
But I should, again, emphasize that it's not Dara for everyone forever, it's during induction consolidation and for 2 years. So I think that's quite compelling.
One can always in practice deviate from the study, if you have somebody who gets quadruplet induction, and after transplant there MRD negative, maybe you don't need the 2 drugs. But that's an extrapolation, and that's not how the study was done. But I think these the GRIFFIN data really supports the quadruplet induction.
The other point I would make is that it's important to remember that myeloma itself causes devastating impact on the quality of life, right? So high calcium, kidneys, anemia, bone disease, that has a significant impact on the quality of life of a patient. So the more quickly we can debulk the disease and get them into remission, that translates into better outcomes for the patient.
So I think we should use our best drugs and not save them, but not necessarily use them forever. So use them judiciously for a period of time so our patients get the best optimal outcome.
Pharmacy Times®: What are the next steps following these phase 2 GRIFFIN trial results?
Ajai Chari: So this phase 2 study will have a confirmatory phase 3 known as PERSEUS [NCT03710603], and that's basically combining the Dara VRD versus VRD study, but it's a phase 3 global study to expand and confirm these phase 2 study results.