Recently, Lancet Oncology published an update of the MAIA study regarding overall survival (OS). MAIA is an ongoing, multicenter, randomized, open-label, phase 3 trial that enrolled patients at 176 hospitals in 14 countries across North America, Europe, the Middle East, and the Asia-Pacific region. Eligible patients were aged 18 years or older, had newly diagnosed multiple myeloma, and were ineligible for high-dose chemotherapy with autologous stem-cell transplantation (ASCT) because of their age (≥65 years) or comorbidities. Patients were randomly assigned (1:1) to receive 28-day cycles of intravenous daratumumab (16 mg/kg, once per week during cycles 1-2, once every 2 weeks in cycles 3-6, and once every 4 weeks thereafter) plus oral lenalidomide (25 mg on days 1-21 of each cycle) and oral dexamethasone (40 mg on days 1, 8, 15, and 22 of each cycle; daratumumab group) or lenalidomide and dexamethasone alone (control group).
Between March 2015 and Jan 2017, 737 patients were enrolled and randomly assigned to the daratumumab group (n=368) or the control group (n=369). At a median follow-up of 56 months, median progression-free survival (PFS) was not reached (95% CI 54.8-not reached) in the daratumumab group versus 34.4 months (29.6-39.2) in the control group (hazard ratio [HR] 0.53 [95% CI 0.43-0.66]; p<0.0001). Median overall survival was not reached in either group (daratumumab group, 95% CI not reached-not reached; control group, 95% CI 55.7-not reached; HR 0.68 [95% CI 0.53-0.86]; p=0.0013).
Professor Thierry Facon, who is the lead author of the publication, talks to IMS Newsletter for the updated results of the MAIA study.
