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Part 1 of the two-part, randomized, phase III CASSIOPEIA trial evaluated daratumumab in combination with bortezomib, thalidomide, and dexamethasone (D-VTd) as induction and consolidation therapy following auto-HSCT in patients with NDMM.1 During part 2, daratumumab maintenance therapy was compared with observation alone in patients who achieved partial or complete response during part 1.1 Here, we summarize the long-term outcomes of the CASSIOPEIA trial, which were published in Lancet Oncology by Moreau et al.1 |
Key learnings: |
At a median follow-up of 80.1 months from first randomization, median PFS was longer in the D-VTd group compared with the VTd group (83.7 months vs 52.8 months; HR, 0.61; p < 0.0001). |
At a median follow-up of 70.6 months from second randomization, PFS was longer in the daratumumab maintenance group compared with the observation group (HR 0.49; p <0.0001). The estimated 72-month PFS rates were 57.1% in the daratumumab group and 36.5% in the observation group. |
OS was longer in the D-VTd group; the estimated 72-month OS rates were 86.7% and 77.7% in the D-VTd and VTd groups, respectively. Median OS was not reached in either group. |
Patients treated with daratumumab maintenance therapy experienced higher rates of sustained MRD negativity at 12 and 24 months, at both 10⁻⁵ and 10⁻⁶ sensitivity thresholds, regardless of whether they had previously been treated with D-VTd or VTd. |
Due to its increased efficacy, delayed disease progression, and sustained responses, these data highlight the potential benefits of incorporating daratumumab into induction and maintenance therapies for NDMM. |
Abbreviations: auto, autologous; D-VTd, daratumumab-bortezomib-thalidomide-dexamethasone; HSCT, hematopoietic stem cell transplantation; MRD, measurable residual disease; NDMM, newly diagnosed multiple myeloma; OS, overall survival; PFS, progression-free survival; VTd, bortezomib-thalidomide-dexamethasone.
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