Lancet Oncology recently published a study on the CASSIOPEIA study, which is a two-part, open-label, randomized, phase 3 trial of patients aged 18-65 years with newly diagnosed multiple myeloma who are eligible for ASCT. In part 1, patients were randomly assigned (1:1) to induction and consolidation with daratumumab, bortezomib, thalidomide and dexamethasone (D-VTd) or VTd. Patients still on study who had a partial response or better were randomly assigned (1:1) to daratumumab 16 mg/kg IV every 8 weeks or observation only for up to 2 years.
Between May 2016 and June 2018, 886 patients (458 [84%] of 543 in the D-VTd group and 428 [79%] of 542 in the VTd group) were randomly assigned to daratumumab maintenance (n=442) or observation only (n=444). At a median follow-up of 35.4 months from second randomization, median PFS with daratumumab versus 46.7 months with observation only (hazard ratio 0.53, 95% CI 0.42-0.68, p<0.0001). A prespecified analysis of PFS results showed a significant interaction between maintenance and induction and consolidation therapy (p<0.0001).
Professor Pieter Sonneveld, who is the last author of the publication, talks to IMS Newsletter for the maintenance results of the CASSIOPEIA study and the implications they have in everyday clinical practice.
