Efficacy Data in the Phase 3 MAIA Study for Multiple Myeloma
Sagar Lonial, MD, FACP, discusses the efficacy data from the phase 3 MAIA study, as well as the role of daratumumab when treating newly diagnosed patients with multiple myeloma.
Sagar Lonial, MD, FACP: What we saw at ASH [American Society of Hematology] this year was an update of the phase 3 randomized MAIA trial, presented by Dr Shaji Kumar. What was really striking is that with a median follow-up now of about 48 months, or 4 years, it looks like roughly 60% to 70% of patients continue to remain in remission. This suggests that the combination of daratumumab/lenalidomide/dexamethasone—as opposed to lenalidomide/dexamethasone, where the median PFS [progression-free survival] was somewhere around 25 months, which is what we would have expected with lenalidomide/dexamethasone in this patient population—not only deepens response with a much higher rate of MRD [minimal residual disease] negativity and a much higher rate of complete remission, but also seems to really translate to improvements in progression-free survival.
When we think about lenalidomide/daratumumab/dexamethasone, for instance, in the POLLUX study in first-relapse myeloma, we know that the median progression-free survival is somewhere between 4 and 5 years. What it looks like from the MAIA study update that Dr Kumar presented is that this is similar for newly diagnosed myeloma as well. This would, in fact, make it one of the longest progression-free survivals we see in a newly diagnosed myeloma patient population, and it really raises the question of whether we should consider this triplet for transplant-eligible patients because of the very long PFS and deep responses.
One could make the case that speed of response in a transplant-eligible patient population is just as important as depth of response. And so, maybe we can’t make this generalization to the younger, fitter patient population. But I think given the fact that daratumumab, particularly in the subQ formulation, is a relatively easy drug to administer and is not associated with significant impacts on quality of life—particularly the once-a-month administration of subQ [subcutaneous] daratumumab—this really makes this a pretty reasonable treatment opportunity, particularly for the standard-risk patients. And given this long follow-up from the MAIA study, I think we have good phase 3 evidence supporting its routine use in this patient population.
Transcript edited for clarity.
Case: A 78-Year-Old Man with Multiple Myeloma
Initial Presentation
- An active 78-year-old man presents with a year history of progressive fatigue; he feels joint and muscle pain diffusely for about 2 months
- PMH: suffered a myocardial infarction 4 years ago; LVEF 45%
- PE: bony tenderness appreciated on the hips and lower back
Clinical Workup
- Labs: Hb 10.9 g/dL, calcium 10.0 mg/dL, LDH 160 U/L, creatinine 2.1 mg/dL, albumin 3.3 g/dL, beta-2 microgloblulin 5.2 mcg/mL, M-protein 2.6 g/dL, lambda free light chains 4.1 mg/dL
- Hepatitis B negative
- Skeletal survey and MRI revealed lytic bone lesions in the left hip, pelvis and L2 vertebrae
- Bone marrow shows 70% plasma cells IgG k restricted
- FISH: normal
- Diagnosis: R-ISS stage II MM
- ECOG 0
Treatment
- Patient is ineligible for ASCT due to comorbidities
- Initiated treatment with daratumumab + lenalidomide + dexamethasone
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