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Responses Improved for Newly Diagnosed Myeloma in Phase III CASSIOPEIA Trial

Phillipe Moreau, MD
Published Online:7:52 PM, Thu July 11, 2019

Phillipe Moreau, MD, head of the Hematology Department at the University Hospital of Nantes, France, discusses the results from the randomized, open-label, multicenter phase III CASSIOPEIA trial. The results of the trial led to a priority review designation from the FDA for the combination of daratumumab (Darzalex) plus bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone (VTd) for patients with treatment-naïve multiple myeloma who are candidates for autologous stem cell transplant (ASCT).

Over 1000 patients with newly diagnosed multiple myeloma were randomized to receive VTd either with or without daratumumab. The trial was separated into 2 parts; this included an induction and consolidation phase followed by maintenance with either durvalumab or observation.

The stringent complete response rate was 28.9% in the combination arm versus 20.3% in the control arm. Additionally, the progression-free survival (PFS) rate at 18 months was 92.7% versus 84.6%, respectively. Overall survival (OS) data were immature, and neither arm reached a median OS.

Moreau says the reason for conducting this study was to improve on the results seen with the standard of care of VTd followed by ASCT, followed by VTd consolidation. These findings showed an increased response rate with the addition of daratumumab, while the agent also improved the quality of response, depth of response, and minimal residual disease negativity. Moreau adds that this translates to a better PFS, with a hazard ratio of less than 0.5 compared with VTd alone, which is significant.

This study could be a game changer, Moreau concludes; the CASSIOPEIA trial will be pivotal for the approval of daratumumab in the context of ASCT.
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