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EC approves subcutaneous daratumumab in combination with VRd for NDMM regardless of transplant eligibility
On April 7, 2025, the European Commission approved subcutaneous daratumumab (D) in combination with bortezomib-lenalidomide-dexamethasone (VRd) for the treatment of patients with newly diagnosed multiple myeloma regardless of transplant eligibility.1
This approval was based on data from the phase III PERSEUS trial.1 The Multiple Myeloma Hub has previously reported on the U.S. Food and Drug Administration (FDA) approval, as well as the primary safety and efficacy data from the PERSEUS trial (NCT03710603).
PERSEUS pivotal data1
In total, 395 patients with newly diagnosed multiple myeloma who were ineligible for transplant or for whom allogeneic stem cell transplantation was not planned as initial therapy were randomized 1:1 to receive D-VRd (n = 197) or VRd (n = 198).
At a median follow-up of 59 months:
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The D-VRd regimen achieved a significantly higher minimal residual disease-negativity rate (sensitivity of 10−5) vs VRd (60.9% vs 39.4%; p < 0.0001).
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The proportion of patients achieving sustained minimal residual disease-negativity for ≥12 months was almost double with D-VRd vs VRd (48.7% vs 26.3%; p < 0.0001).
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The D-VRd regimen resulted in a higher complete response rate vs VRd (81.2% vs 61.6%; p < 0.0001).
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D-VRd significantly reduced the risk of progression or death by 43% compared to VRd (p < 0.0005), with the median progression-free survival not reached for D-VRd vs 52.6 months for VRd.
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The safety profile of D-VRd was consistent with known profiles, with the most common (>10%) Grade 3/4 hematologic and non-hematologic adverse events being neutropenia (44.2% vs 29.7%), thrombocytopenia (28.4% vs 20.0%), anemia (13.2% vs 11.8%), peripheral neuropathies (8.1% vs 8.2%), diarrhea (12.2% vs 9.2%), and COVID-19 (11.2% vs 4.6%) for D-VRd vs VRd, respectively.
References
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