Phase 3 randomized study of isatuximab (Isa) plus lenalidomide and dexamethasone (Rd) with bortezomib versus isard in patients with newly diagnosed transplant ineligible multiple myeloma (NDMM TI)
Summary:
This abstract summarizes the results of a phase 3 randomized study evaluating the efficacy and safety of a treatment regimen comprising isatuximab (Isa) plus lenalidomide and dexamethasone (Rd) with the addition of bortezomib compared to a regimen without bortezomib in patients with newly diagnosed transplant ineligible multiple myeloma (NDMM TI). The primary objective was to assess the impact of adding bortezomib on the rate of minimal residual disease (MRD) negativity at 10-5 at 18 months. The study enrolled 270 patients, with 135 patients in each treatment arm. The results demonstrated that the addition of bortezomib significantly increased the MRD negativity rate at 10-5 at 18 months compared to the regimen without bortezomib (47% vs. 24%). This improvement was consistent across subgroups. At a median follow-up of 21.2 months, there were no significant differences in relapse or death rates between the two arms. The safety profile of the bortezomib-containing regimen was consistent with the addition of bortezomib. Based on these findings, the study supports the use of the bortezomib-containing regimen as a new standard of care for non-frail NDMM TI patients. Further research and clinical trials are warranted to validate these results and explore long-term outcomes.
Key Points:
1. CD38 targeting immunotherapy in combination with lenalidomide and dexamethasone is the current standard of care for NDMM TI.
2. The study investigated the efficacy and safety of IsaRd (isatuximab, lenalidomide, and dexamethasone) versus Isa-VRd (isatuximab, bortezomib, lenalidomide, and dexamethasone) in NDMM TI patients.
3. The primary endpoint of the study was the minimal residual disease (MRD) 10-5 negative rate at 18 months from treatment start.
4. The MRD negativity rates at 10-5 at 18 months were significantly higher in the Isa-VRd arm compared to the IsaRd arm (47% vs. 24%).
5. The addition of bortezomib to the treatment regimen significantly deepened responses, including a significant increase in the MRD negative rate at 10-5.
6. The MRD benefit was consistent across subgroups.
7. At 21.2 months median follow-up, there were no significant differences in relapse or death rates between the two arms.
8. The safety profile of Isa-VRd was consistent with the addition of bortezomib.
9. The study supports Isa-VRd as a new standard of care for non-frail patients with NDMM TI.
Authors:
Xavier P. Leleu, Cyrille Hulin, Jerome Lambert, Arthur Bobin, Salomon Manier, Aurore Perrot, Arnaud Jaccard, Lydia Montes, Lionel Karlin, Pascal Godmer, Thomas Chalopin, Borhane Slama, Kamel Laribi, Marie-Lorraine Chretien, Mohamad Mohty, Cyrille Touzeau, Philippe Moreau, Herve Avet-Loiseau, Jill Corre, and Thierry Facon.
Clinical Trial Registration Number: NCT04751877
ASCO Abstract# 7501
DOI: 10.1200/JCO.2024.42.16_suppl.7501
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18 июн 2024
