Abstract Title:

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 Sarclisa (isatuximab) (https://www.myeloma.org/sarclisa-isatuximab-irfc), Velcade (bortezomib) (https://www.myeloma.org/velcade-bortezomib), Revlimid (lenalidomide) (https://www.myeloma.org/revlimid-lenalidomide), and dexamethasone (https://www.myeloma.org/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 (https://clinicaltrials.gov/study/NCT03319667)
Abstract# 7500 (https://meetings.asco.org/abstracts-presentations/231717)
DOI: 10.1200/JCO.2024.42.16_suppl.7500