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Efficacy and safety of Isa-VRD in the treatment of transplant-ineligible patients with NDMM: Phase III BENEFIT trial

By Jennifer Reilly

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Aug 19, 2024

Learning objective: After reading this article, learners will be able to cite a new clinical development in newly diagnosed multiple myeloma.



Data from the phase III BENEFIT trial (NCT04751877) evaluating the impact of the addition of weekly bortezomib to isatuximab, lenalidomide, and dexamethasone (Isa-VRd) for the treatment of transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM) were published by Leleu et al.1 in Nature Medicine. The efficacy and safety of Isa-Rd with and without the addition of bortezomib was evaluated. The primary endpoint was measurable residual disease (MRD) benefit at 18 months post randomization.


Key learnings:

At 18 months, the MRD negativity rate at ×10-5 was higher in the Isa-VRd arm compared with Isa-Rd arm (53% vs 26%; odds ratio, 3.16; 95% confidence interval, 1.89–5.28; p < 0.0001).

Very good partial response and complete response or better was higher with Isa-VRd compared with Isa-Rd (58% vs 31%; odds ratio, 2.97; 95% confidence interval, 2–5; p < 0.0001).

Neutropenia was the most common adverse event reported in both cohorts.

  • There was a higher incidence of neutropenia in the Isa-Rd arm compared with Isa-VRd arm (61% vs 57%).

Thrombocytopenia was more frequent in patients treated with Isa-VRd compared with those treated with Isa-Rd (27% vs 14%).

Neuropathy was more common in patients treated with Isa-VRd compared with those treated with Isa-Rd (52% vs 28%).

  • Grade ≥3 neuropathy was experienced by 27% and 10% of patients in the Isa-VRD and Isa-RD arms, respectively. 

Isa-VRd demonstrated higher rates of MRD negativity and deeper levels of response, highlighting the potential of Isa-VRd as a new standard of care treatment for transplant-ineligible patients with NDMM.

References

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