Luciano J. Costa, MD, PhD, discussed the results from the phase 2 GRIFFIN study, designed to evaluate the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in transplant-eligible patients with multiple myeloma.
As part of CancerNetwork’s Face-Off video series, Luciano J. Costa, MD, PhD, professor of medicine - hematology and oncology, Department of Medicine, University of Alabama at Birmingham, discussed the results from the phase 2 GRIFFIN study (NCT02874742), evaluating daratumumab (Darzalex) in addition to bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (RVd) induction/consolidation therapy along with lenalidomide maintenance in patients with multiple myeloma.
Costa: So, the GRIFFIN study is a trial that took the standard of care in the US for transplant-eligible patients. There was a combination of bortezomib, lenalidomide, and dexamethasone induction, followed by autologous transplant followed by 2 more cycles of bortezomib, lenalidomide, and dexamethasone, followed by lenalidomide maintenance, and compared this standard with the same regimen with the addition of daratumumab [Darzalex]. So, it's VRd versus dara-VRd. And the maintenance was [lenolidomide] versus [daratumumab] for 2 years.
This study was designed in a randomized phase 2 study with about 100 patients in each arm. And the primary end point was stringent [complete response (CR)]. This trial was reported many times before, and met the primary end point. The stringent CR was more frequent, as we would expect with dara-VRd.
Now, what is exciting that has come up on subsequent updates is that the [minimal residual disease (MRD)] negativity rate is also higher with dara-VRd. So, in my opinion that speaks for the depth of response in a more meaningful way, than the stringent CR does. And even though progression-free survival is not the primary end point of that study, the most recent update to that study shows there is also a progression-free survival advantage of dara-VRd over VRd. So, what that means is that we do provide what I consider strong evidence, particularly when taken in context with every other trial done with the addition of monoclonal antibody to establish regimens that consistently show the same thing: deeper, more frequent responses and longer progression-free survival. So I consider that to be a sufficient evidence to call dara-VRd standard of care for newly diagnosed transplant-eligible myeloma patients.
Transcription edited for clarity.