FDA approves Isa-VRd for transplant-ineligible NDMM

On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.¹

This approval was based on data from the phase III IMROZ (NCT03319667) trial.

IMROZ pivotal data²

IMROZ, an open-label, phase III trial, enrolled adult patients with newly diagnosed multiple myeloma ineligible for transplant. Patients were randomly assigned 3:2 to receive isatuximab-VRd (Isa-VRd) or VRd alone. The primary endpoint was progression-free survival (PFS), with secondary endpoints including complete response, measurable residual disease negativity, and overall survival (OS).

• At a median follow-up of 59.7 months, median primary endpoint of PFS was not reached in the Isa-VRd arm and was 54.3 months in the VRd arm.
• Key secondary outcomes in the Isa-VRd arm vs VRd arm were as follows:
  • The overall response rate and the complete response or better rate were 91.3% and 74.7% vs 92.3% and 64.1%
  • The MRD negativity rates were 58.1% vs 43.6%
  • Sustained MRD negativity at ≥12 months were 46.8% vs 24.3%
  • The 60-month OS rates were 72.3% vs 66.3%
• Common adverse effects included infections, diarrhea, fatigue, neuropathy, and pneumonia.