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Moreau detailed the patient characteristics of those enrolled on the CASSIOPEIA trial, which investigating bortezomib, thalidomide and dexamethasone plus daratumumab in patients with newly diagnosed multiple myeloma.
Philippe Moreau, MD, of the University Hospital of Nantes, spoke with CancerNetwork® at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, details results from part 2 of the phase 3 CASSIOPEIA trial (NCT02541383), which utilized daratumumab (Darzalex) maintenance following bortezomib, thalidomide and dexamethasone (VTd) in patients with newly diagnosed multiple myeloma.
In part 2, we were able to randomize 886 patients—442 [to] daratumumab maintenance [for] 2 years and 444 for observation. In fact, the patient characteristics were well balanced [between] the 2 groups. Of note, 76.2% of those in the daratumumab arm and 75.9% of those in the observation arm were MRD negative at the time of the second randomization. The study met its primary end point, indicating that daratumumab is significantly improving progression-free survival from second randomization versus observation with a hazard ratio of 0.53. [However], when we looked at the subgroup analysis and pre-specified subgroup analysis, we saw that the benefit of daratumumab maintenance was observed only in patients who did not receive daratumumab up front. Patients who only received VTd up front benefited from daratumumab maintenance. That is a very important finding.
Moreau P, Sonneveld P. Daratumumab (DARA) maintenance or observation (OBS) after treatment with bortezomib, thalidomide and dexamethasone (VTd) with or without DARA and autologous stem cell transplant (ASCT) in patients (pts) with newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 2. J Clin Oncol. 2021;39(suppl 15):8004. doi:10.1200/JCO.2021.39.15_suppl.8004