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 analysis1.
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 %. “These findings reflect a reduction of 40.4 % for disease progression or death,” commented Prof. Facon. Furthermore, the minimal residual disease negativity (10-5) rates were 58.1 and 43.6 %, respectively, favouring the experimental arm 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 the 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 treatment option for frontline disease control, supporting Isa-VRd as a new standard of care for patients aged ≤80 years with transplant-ineligible, newly diagnosed MM,” concluded Dr Facon.
Medical writing support was provided by Robert van den Heuvel.