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CEPHEUS: Long-term follow-up of D-VRd vs VRd in transplant-ineligible NDMM
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The current SoC for transplant-ineligible NDMM is triplet therapy with D-Rd or VRd.1 The phase III CEPHEUS trial (NCT03652064) evaluated the efficacy and safety of the quadruplet therapy D-VRd vs VRd in patients with NDMM who were transplant-ineligible or transplant-deferred.1 Eligible patients were randomized to receive D-VRd (n = 197) or VRd (n = 195).1 The primary endpoint was the overall MRD-negativity rate, defined as the proportion of patients who achieved ≥CR and had MRD-negative status after randomization and before progression. Key secondary endpoints included ≥CR rate, PFS, and sustained MRD-negativity rate at ≥12 months. Results were published in Nature Medicine by Usmani et al.1 |
| Key learnings |
| After a median follow-up of 58.7 months, the overall MRD negativity rate with CR or ≥CR was higher in the D-VRd vs VRd group (60.9% vs 39.4%; OR, 2.37; 95% CI, 1.58–3.55; p < 0.0001). |
| ≥CR rates (81.2% vs 61.6%; OR, 2.73; 95% CI, 1.71–4.34; p < 0.0001) and sustained MRD-negativity rates (48.7% vs 26.3%; OR, 2.63; 95% CI, 1.73–4.00; p < 0.0001) were higher in the D-VRd vs VRd group, respectively. |
| The most frequent Grade 3 or 4 TEAEs were neutropenia (44.2% vs 29.7%) and thrombocytopenia (28.4% vs 20.0%), while SAEs occurred in 72.1% vs 67.2% of patients in the D-VRd and VRd groups, respectively. |
| A lower risk of disease progression or death translated to improved PFS in the D-VRd vs VRd group (HR, 0.57; 95% CI, 0.41–0.79; p = 0.0005). |
| These findings show that D-VRd improved rates of MRD negativity and durability of responses compared to VRd in patients with NDMM who were transplant-ineligible or transplant-deferred. This is consistent with the PERSEUS trial, supporting the D-VRd quadruplet therapy as the new SoC. |
Abbreviations: CI, confidence interval; CR, complete response; D-VRd, daratumumab-bortezomib-lenalidomide-dexamethasone; HR, hazard ratio; MRD, measurable residual disease; NDMM, newly diagnosed multiple myeloma; PFS, progression-free survival; SoC, standard of care; SAE, serious adverse event; TEAE, treatment-related adverse event; VRd, bortezomib-lenalidomide-dexamethasone.
- Usmani SZ, Facon T, Hungria V, et al. Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: the randomized phase 3 CEPHEUS trial Nat Med. 2025. Online ahead of print. DOI: 10.1038/s41591-024-03485-7
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