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CARTITUDE-4 MRD negativity analysis: Cilta-cel for len-refractory MM
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MRD is an increasingly recognized prognostic marker in MM, providing a sensitive measure for response to therapy. Sustained MRD negativity ≥12 months has been associated with longer PFS and OS. As treatment strategies evolve, MRD is under evaluation as a predictor of long-term outcomes in clinical trials for MM.1 During the ASH congress 2024, Rakesh Popat presented the latest data, including an MRD analysis, from the phase III CARTITUDE-4 trial (NCT04181827), which compared cilta-cel with SoC therapy for the treatment of lenalidomide-refractory MM (N = 419).1 |
| Key learnings |
| Among patients evaluable for MRD, 85.6% of those treated in the cilta-cel arm (n = 139) observed MRD negativity at a sensitivity of ×10⁻⁶, compared with 18.6% in the SoC group (n = 102) (OR 28.5; p < 0.0001). |
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82.1% of patients treated in the cilta-cel arm observed sustained MRD negativity (≥12 months) at a sensitivity of ×10⁻⁵, compared with 25.2% in the SoC group (OR 12.3; p < 0.0001). |
| The 30-month PFS and OS were 93.2% and 97.3%, respectively, in patients treated with cilta-cel who achieved sustained MRD negativity ≥CR. |
| Patients treated with cilta-cel achieved deep (×10⁻⁶) and sustained MRD negativity ≥CR rates, which correlated with prolonged PFS and OS, supporting the prognostic value of MRD negativity in CAR T-cell therapy. |
Abbreviations: CAR, chimeric antigen receptor; cilta-cel, ciltacabtagene autoleucel; CR, complete response; MRD, measurable residual disease; OR, odds ratio; OS, overall survival; PFS, progression-free survival; SoC, standard-of-care.
- Popat R. Ciltacabtagene autoleucel (cilta-cel) vs standard of care (SoC) in patients with lenalidomide (len)-refractory multiple myeloma (MM) after 1–3 lines of therapy: Minimal residual disease (MRD) negativity in the phase 3 CARTITUDE-4 trial. Oral Abstract #1032. Presented at 66th American Society of Hematology Annual Meeting and Exposition; Dec 7–10, 2024; San Diego, US.
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