Johnson & Johnson (JNJ) said Tuesday that data from two phase 3 trials show a Darzalex Faspro-based regimen demonstrated "deep and sustained" minimal residual disease, or MRD, negativity and long-term progression-free survival in patients with newly diagnosed multiple myeloma, regardless of transplant status.

The Perseus study, which included transplant-eligible patients, showed that those treated with Darzalex Faspro plus bortezomib, lenalidomide, and dexamethasone, followed by Darzalex Faspro and lenalidomide maintenance, had more than double the rate of sustained MRD negativity for 24 months compared to those on VRd with lenalidomide alone.

At 48 months, 95.3% of patients on the Darzalex-based regimen were still free of disease progression.

The Cepheus study, which included transplant-ineligible patients, also showed higher MRD negativity rates and improved progression-free survival when Darzalex Faspro was added to VRd, even in older or frail patients. At 54 months, 69% of patients on the Darzalex-based regimen were progression-free, versus 48% with VRd alone.

The safety profile in both trials was consistent with that previously reported for Darzalex Faspro, the company said.

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