IMROZ Trial: Redefining Multiple Myeloma Treatment with Quadruple Therapy
Introduction
The IMROZ trial has brought significant advancements in the treatment landscape for multiple myeloma, particularly for patients who are transplant-ineligible. This trial explored the efficacy and safety of adding isatuximab to the standard VRd regimen (bortezomib, lenalidomide, and dexamethasone), forming the quadruple regimen Isa-VRd. With its promising results, the IMROZ trial presents a potential shift in the standard of care for these patients.
Trial Design
The IMROZ trial enrolled 447 newly diagnosed multiple myeloma patients who were ineligible for transplantation, mostly aged between 65 and 80 years. The participants were randomized to receive either the Isa-VRd regimen or the standard VRd regimen. The primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS), minimal residual disease (MRD) negativity rates, and safety profiles.
Key Findings
The trial found that the Isa-VRd regimen significantly improved progression-free survival compared to VRd alone. Specifically, the 5-year PFS rates were 63% for Isa-VRd compared to 45% for the control group. Additionally, there was a higher rate of MRD negativity with Isa-VRd, with 58% achieving MRD negativity compared to 43% in the VRd group.
Safety Profile
While the Isa-VRd regimen demonstrated improved efficacy, it also came with a high rate of adverse effects. Grade 3 or higher adverse events were noted in the Isa-VRd group (84%) compared to the VRd group (91.6%). Notably, treatment-related deaths were higher in the Isa-VRd group, with 11% compared to 5.5% in the VRd group.
FDA Approval
The positive outcomes from the IMROZ trial have led to the FDA approving the use of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients who are not candidates for transplantation. This approval opens up new avenues for treatment and offers hope for better management of the disease.
Conclusion
The IMROZ trial has demonstrated that adding isatuximab to the VRd regimen significantly improves efficacy, as evidenced by higher PFS and MRD negativity rates. Despite the increased adverse events, the benefits appear to outweigh the risks for many patients, positioning Isa-VRd as a potential new standard of care for transplant-ineligible multiple myeloma patients
