EHA2021: MAIA Trial Update on Daratumumab-Based Therapy for Newly Diagnosed Myeloma
Posted: Monday, June 14, 2021
In the phase III MAIA trial, the monoclonal antibody daratumumab plus lenalidomide and dexamethasone reduced the risk of disease progression or death by 44% versus lenalidomide plus dexamethasone in patients with newly diagnosed multiple myeloma, according to Thierry Facon, MD, of the University of Lille, France, and colleagues. The 5-year follow-up of transplant-ineligible patients from the prespecified interim overall survival analysis was presented during the European Hematology Association Virtual Congress (EHA2021; Abstract LB1901).
“The favorable benefit-risk profile observed supports the use of daratumumab plus lenalidomide and dexamethasone,” the investigators commented. “These results, together with the overall survival benefit observed in [the phase III ALCYONE trial], support the use of front-line daratumumab-based combination regimens to maximize progression-free survival for optimal long-term outcomes.”
A total of 737 patients were randomly assigned in a 1:1 ratio to receive lenalidomide plus dexamethasone with or without daratumumab. Compared with lenalidomide plus dexamethasone, the addition of daratumumab reduced the risk of death by 32%; the median duration of overall survival was not reached in either treatment arm (hazard ratio = 0.68; P = .0013). The estimated 5-year overall survival rates were 66.3% and 53.1% with and without daratumumab, respectively. The updated median duration of progression-free survival was not reached with daratumumab plus lenalidomide and dexamethasone and was 34.4 months with lenalidomide plus dexamethasone (hazard ratio = 0.53; P < .0001). The estimated 5-year progression-free survival rate was higher with daratumumab than without (52.5% vs. 28.7%). The updated objective response rates were 92.9% and 81.6% with and without daratumumab, respectively (P < .0001).
The longer follow-up did not reveal any new safety signals. Neutropenia (54.1% vs. 37.0%), pneumonia (19.2% vs. 10.7%), anemia (16.8% vs. 21.6%), and lymphopenia (16.5% vs. 11.2%) were among the most commonly reported grade 3 or 4 treatment-emergent adverse events with and without daratumumab.
Disclosure: For disclosures of the study authors, visit library.ehaweb.org.
