▎WuXiEdited by Kant Content Team

Recently, Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA, seeking approval for Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd quadruplet regimen) for the treatment of newly diagnosed multiple myeloma (NDMM) adult patients who have delayed or are ineligible for autologous stem cell transplantation (ASCT).The press release noted that the results of the Phase 3 CEPHEUS clinical study indicate that the D-VRd quadruplet regimen can be a potential standard treatment for NDMM patients, regardless of whether they are eligible for transplantation.

CEPHEUS is an ongoing multi-center, randomized, open-label Phase 3 study designed to compare the efficacy and safety of D-VRd versus bortezomib, lenalidomide, and dexamethasone (VRd) in NDMM patients for whom ASCT is not an initial treatment option.

The analysis showed that the median follow-up period was 58.7 months.Compared with VRd, the D-VRd regimen increases the depth and durability of patients' responses. In the D-VRd group, 60.9% of patients achieved minimal residual disease (MRD) negativity, compared to 39.4% in the VRd group (P<0.0001).The study also showed that, compared with VRd, D-VRd significantly reduced the risk of disease progression or death by 43% (HR=0.57, 95% CI: 0.41-0.79, P<0.0005), andThe overall complete response (CR) rate was higher in the D-VRd group, reaching 81.2%, compared to 61.6% in the VRd group (P<0.0001).The overall safety of D-VRd is consistent with the known safety profiles of Darzalex Faspro and VRd.

Darzalex Faspro, jointly developed by Johnson & Johnson and Genmab, is the first anti-CD38 antibody that can be administered via subcutaneous injection, reducing treatment time for patients from several hours to just a few minutes.Darzalex Faspro has been approved by the U.S. FDA for eight indications in multiple myeloma, three of which are for frontline treatment of newly diagnosed multiple myeloma patients, regardless of their eligibility for transplantation.