Front-Line Daratumumab Triplet: Updated Overall Survival Results From MAIA
Posted: Tuesday, November 16, 2021
Overall survival improved with the addition of the monoclonal antibody daratumumab to lenalidomide and dexamethasone, versus lenalidomide and dexamethasone alone, in transplantation-ineligible patients with newly diagnosed multiple myeloma, according to updated results (median follow-up, 56.2 months) from the randomized phase III MAIA trial. According to Saad Z. Usmani, MD, of Levine Cancer Institute in Charlotte, North Carolina, and colleagues, these findings support the front-line use of the triplet in this patient population. What’s more, “the median progression-free survival is anticipated to be more than 5 years, which, to our knowledge, would be unprecedented in [these] patients,” they wrote in The Lancet Oncology.
Previously, the primary analysis (median follow-up, 28.0 months) had shown that the daratumumab regimen improved progression-free survival versus the control. The ongoing MAIA trial includes 762 adults (treated at 176 hospitals in 14 nations), all of whom were ineligible for high-dose chemotherapy with autologous stem cell transplantation because of their age (≥ 65 years) or comorbidities. Randomization was 1:1, and neither patients nor investigators were masked to treatment assignment.
In this analysis, median overall survival was not reached in either group, but the results clearly favored the daratumumab arm (daratumumab, 95% confidence interval = not reached to not reached; control, 95% CI = 55.7 months to not reached; hazard ratio, 0.68; P = . 0013). Further, the updated median progression-free survival was not reached in the daratumumab arm (95% CI = 54.8 months to not reached); it was 34.4 months (95% CI =, 29.6–39.2 months) in the control arm (hazard ratio = 0.53; P < .0001).
No new safety concerns emerged, reported Dr. Usmani and co-investigators. Serious adverse events occurred in 281 (77%) and 257 (70%) patients in the daratumumab and control arms, respectively.
Disclosure: The study authors’ disclosure information can be found at thelancet.com.
