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GMMG-HD7 final analysis: Isa-RVd vs RVd in transplant-eligible patients with NDMM
Isatuximab (Isa), an anti-CD38 monoclonal antibody, in combination with lenalidomide, bortezomib, and dexamethasone (RVd), demonstrated improved MRD negativity rates vs RVd alone in transplant-eligible patients with NDMM in Part I of the phase III GMMG-HD7 trial (NCT03617731). The pre-specified final analysis of Part I of the GMMG-HD7 trial, evaluating the PFS benefit of Isa-RVd vs RVd, was recently published by Mai et al. in the Journal of Oncology.1 In Part I, patients were randomly assigned 1:1 to receive induction therapy with Isa-RVd (n = 331) or RVd (n = 329), with three 6-weekly cycles of RVd. In Part II, patients were randomly reassigned to receive maintenance therapy with lenalidomide (R) or Isa-R. The endpoints for the final analysis of Part I included the rates of post-transplant MRD negativity, PFS from the first random assignment, and the impact of MRD status on PFS.
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Key learnings |
Higher rates of CR (43.5% vs 34.0%; p = 0.13) and MRD negativity (66.2% vs 47.7%; p < 0.0001) were observed in the Isa-RVd vs RVd groups, respectively. |
Post-transplant MRD-negativity rates after the first random assignment were higher in the Isa-RVd vs RVd groups, irrespective of maintenance therapy (HR, 0.70; 95% CI: 0.52–0.95; p = 0.0184). |
Multivariate analysis showed PFS benefit for Isa-RVd vs RVd, including established prognostic factors (HR, 0.61; 95% CI: 0.45–0.83; p = 0.002). Isa-RVd PFS benefit vs RVd was also demonstrated by weighted risk set estimator analysis, accounting for second random assignment and maintenance (p = 0.016). |
In all patients who achieved MRD-negative vs MRD-positive status, the landmark analyses showed prolonged PFS from EOI (HR, 0.38; 95% CI: 0.26–0.55; p < 0.001) and EOT (HR, 0.42; 95% CI: 0.28–0.63; p < 0.001). |
Isa-RVd shows consistent PFS benefit and higher MRD-negativity rates compared with RVd across most subgroups, supporting the use of Isa quadruplet therapy as the SoC in transplant-eligible patients with NDMM. |
CR, complete response; EOI, end of induction; EOT, end of transplant; HR, hazard ratio; Isa, isatuximab; MRD, measurable residual disease; NDMM, newly diagnosed multiple myeloma; PFS, progression-free survival; R, lenalidomide; RVd, lenalidomide, bortezomib, and dexamethasone; SoC, standard of care.
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What is the most significant limitation you have identified when using lenalidomide or pomalidomide for the treatment of patients with multiple myeloma?
