Isa-VRd proves its value in newly diagnosed MM in the IMROZ trial

Isatuximab (Isa) combined with bortezomib, lenalidomide, and dexamethasone (VRd) yielded better health outcomes than VRd alone for the first-line treatment of transplant-ineligible participants with newly diagnosed multiple myeloma (MM) in the phase 3 IMROZ study.

The anti-CD38 monoclonal antibody isatuximab was added to VRd (Isa-VRd) to challenge the current standard frontline VRd treatment for patients with newly diagnosed MM. The phase 3 IMROZ trial (NCT03319667) randomised 446 participants with transplant-ineligible, newly diagnosed MM 3:2 to Isa-VRd or VRd alone. Progression-free survival (PFS) was the main outcome and Prof. Thierry Facon (University of Lille, France) presented the findings of the current interim analysis [1].

After a median follow-up of 5 years, the median PFS was not reached in the experimental arm and 54.3 months in the control arm (HR 0.60; 98.5% CI 0.41–0.88; log-rank P=0.0005). The corresponding 60-month PFS rates were 63.2% and 45.2%, respectively. “These findings reflect a reduction of 40.4% for disease progression or death,” commented Prof. Facon. Furthermore, the measurable residual disease negativity (10^-5) rates were 58.1% and 43.6%, respectively, favouring the experimental over the control arm. Although the overall survival data was immature, there was a favourable trend for the Isa-VRd arm compared with the VRd arm, with 60-month overall survival rates of 72.3% and 66.3% (HR 0.78; 99.97% CI 0.41–1.48).

Serious adverse events were seen in 70.7% and 67.4% of participants in the experimental arm and control arm, respectively. Grade ≥3 infections (44.9 vs 38.1%), grade ≥3 cataracts (15.6 vs 11.0%), and grade ≥3 diarrhoea (7.6 vs 8.3%) were common side effects in both arms.

“The improved efficacy of isatuximab plus VRd, combined with a consistent safety profile, provides an important frontline treatment, supporting Isa-VRd as a new standard of care for patients aged ≤80 years with transplant-ineligible, newly diagnosed MM,” concluded Prof. Facon.

1. Facon T, et al. Phase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ). S100, EHA congress 2024, 13–16 June, Madrid, Spain.

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Posted on 12 August 2024