The IMROZ trial

Dr Marie Vercruyssen, a haematologist at the Institut Jules Bordet in Brussels, summarised the outcomes of the IMROZ trial, which evaluated the addition of the anti-CD38 monoclonal antibody isatuximab to the VRd regimen in transplant-ineligible patients with newly diagnosed MM. The trial included over 400 patients from various global regions.

The primary endpoint of the study, PFS, was 54 months for the VRd arm, while the PFS was not reached for the Isa-VRd arm. Notably, the projected median PFS for the Isa-VRd arm is approximately 90 months, indicating a significant improvement.

Secondary key endpoints included CR and MRD negativity at a sensitivity level of 10-5, as assessed by NGS. A CR was achieved by three out of four patients, with nearly 60% attaining MRD negativity. Importantly, nearly 50% of these patients achieved sustained MRD negativity for 12 months. Given that MRD negativity, particularly sustained MRD negativity, is widely accepted as a surrogate marker for patient outcomes in MM, these results are considered a substantial advancement in the field.

Regarding safety, the Isa-VRd regimen was well-tolerated, with slightly increased incidences of myelosuppression and infection as expected, but no new safety concerns emerged from the trial.

In conclusion, the IMROZ trial demonstrates that the addition of an anti-CD38 monoclonal antibody to the VRd regimen significantly improves outcomes for transplant-ineligible patients with newly diagnosed MM, establishing Isa-VRd as a new standard of care in this patient population.