CASSIOPEIA phase III study of Darzalex + Velcade + Thalomid + dexamthasone shows efficacy in multiple myeloma.- Genmab
The results of the study showed superior efficacy of D-VTd over VTd alone in combination with autologous stem cell transplantation (ASCT), which led to the regulatory approval of the treatment. The results from the CASSIOPEIA part 2 interim analysis aimed to compare daratumumab maintenance (16 mg/kg every 8 weeks) with observation treatment in all 886 responders from part 1 of the study. The interim analysis showed that patients maintained with daratumumab exhibited significantly longer progression-free survival (PFS) compared to the observation treatment arm. However, stratification of the patients by induction/consolidation treatment revealed that this benefit only appeared in patients previously treated with VTd in CASSIOPEIA part 1. Patients who received D-VTd in part 1 and were placed on daratumumab maintenance showed comparable PFS to the observation group. Furthermore, daratumumab maintenance led to a significantly higher depth of response and no new safety signals were detected. In summary, daratumumab maintenance is beneficial for patients after ASCT who received VTd induction/consolidation.