Johnson & Johnson’s DARZALEX FASPRO® Regimen Shows 95% 4-Year Progression-Free Survival in Newly Diagnosed Myeloma Patients

Johnson & Johnson has revealed that treatment based on DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) achieved a 95% rate of progression-free survival (PFS) at four years in transplant-eligible, newly diagnosed multiple myeloma patients who had sustained minimal residual disease (MRD) negativity.

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This important result highlights the promise of MRD negativity as a substitute endpoint for long-term clinical outcomes in myeloma. The findings were presented at the 2024 American Society of Hematology (ASH) Annual Meeting.

The data show that D-VRd followed by an investigational D-R maintenance regimen is a highly effective treatment option for transplant-eligible patients with newly diagnosed multiple myelom,

The depth and durability of MRD negativity observed—paired with unprecedented progression-free survival at four years underscore the long-term benefit the DARZALEX FASPRO-based regimen can offer patients early in their treatment journey.

Philippe Moreau

Key Findings

  1. The Phase 3 CEPHEUS trial assessed the effectiveness of the DARZALEX FASPRO®-regimen in patients with newly diagnosed multiple myeloma who are candidates for autologous stem cell transplant.
  2. Of patients who became sustained MRD negative, 95% were progression-free at four years.
  3. The trial illustrated that the achievement of MRD negativity is associated with favorable long-term outcomes, including prolonged PFS.

These findings emphasize how crucial it is to include MRD status in multiple myeloma treatment evaluation and decision-making procedures.

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