Phase 3 Study Results of Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) versus VRd for Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma (IMROZ)
Summary:
The Phase 3 IMROZ study compared the efficacy and safety of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). The study included 446 patients and the primary endpoint was progression-free survival (PFS). The results showed that Isa-VRd significantly reduced the risk of progression or death by 40.4% compared to VRd. Isa-VRd also led to deep and sustained responses, with higher rates of complete response (CR), minimal residual disease negativity (MRD-), and sustained MRD-for at least 12 months. The safety profile of Isa-VRd was consistent with the addition of isatuximab to VRd. These findings support Isa-VRd as a potential new standard of care for transplant-ineligible NDMM patients.
Key Points:
1. The Phase 3 IMROZ study compared the efficacy and safety of Isa-VRd versus VRd in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM).
2. Isa-VRd significantly reduced the risk of progression or death by 40.4% compared to VRd.
3. Isa-VRd led to higher rates of complete response (CR) compared to VRd.
4. Isa-VRd also resulted in higher rates of minimal residual disease negativity (MRD-) compared to VRd.
5. Sustained MRD-for at least 12 months was achieved in a higher percentage of patients treated with Isa-VRd compared to VRd.
6. The safety profile of Isa-VRd was consistent with the addition of isatuximab to VRd.
7. Grade 3 treatment-emergent adverse events (TEAEs) were reported in a higher percentage of patients treated with Isa-VRd compared to VRd.
8. Grade 5 TEAEs were reported in a higher percentage of patients treated with Isa-VRd compared to VRd.
9. The percentage of patients experiencing any TEAE leading to definitive treatment discontinuation was similar between Isa-VRd and VRd treatment groups.
Authors:
Thierry Facon, Meletios Athanasios Dimopoulos, Xavier P Leleu, Meral Beksac, Ludek Pour, Roman Hajek, Zhuogang Liu, Jiri Minarik, Philippe Moreau, Joanna Romejko-Jarosinska, Ivan Spicka, Vladimir I. Vorobyev, Michele Cavo, Hartmut Goldschmidt, Thomas G. Martin, Salomon Manier, Marie-France Bregeault, Sandrine Mace,Christelle Berthou, Robert Z. Orlowski
Clinical Trial Registration Number: NCT03319667
Abstract# 7500
DOI: 10.1200/JCO.2024.42.16_suppl.7500
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17 июн 2024
