▎Edited by the WuXi AppTec content team

Recently, Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA, seeking approval for a new indication for Darzalex Faspro. The application proposes the use of Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd quadruplet regimen) for the induction and consolidation treatment of adult patients newly diagnosed with multiple myeloma (NDMM) who are eligible for autologous stem cell transplantation (ASCT). Additionally, it includes the use of Darzalex Faspro in combination with lenalidomide (D-R doublet regimen) as maintenance therapy for the aforementioned patient population. The press release noted,If approved, the Darzalex Faspro-based regimen is expected to provide an effective quadruplet therapy for many NDMM patients eligible for transplantation.

The submission of this sBLA is based on data from the Phase 3 PERSEUS (NCT03710603) study. The primary analysis results show,The study met the primary endpoint of progression-free survival (PFS),Compared with standard therapy,Adding Darzalex Faspro to lenalidomide, bortezomib, and dexamethasone induction and consolidation therapy (VRd triplet regimen) plus lenalidomide maintenance therapy reduced the risk of disease progression or death by 58%.(HR, 0.42; 95% CI: 0.30-0.59; P<0.0001). In addition,Compared with the combination regimen of VRd triplet therapy, ASCT, and lenalidomide maintenance therapy, the use of D-VRd quadruplet regimen and ASCT followed by D-R maintenance therapy achieved deeper remission., the rates of complete response (CR) and deeper responses, stringent complete response (sCR), and minimal residual disease (MRD)-negative were higher.

Overall, among the patients in the D-VRd treatment group who entered the maintenance treatment phase,After at least two years of D-R maintenance therapy, 64% of patients achieved CR and deeper remission with sustained MRD negativity, allowing them to discontinue Darzalex Faspro treatment.The overall safety of receiving D-R maintenance therapy after the D-VRd treatment regimen is consistent with the known safety profiles of Darzalex Faspro, VRd combination therapy, and lenalidomide.

Data from the PERSEUS study were presented as a late-breaking oral abstract (LBA-1) at the 2023 American Society of Hematology (ASH) Annual Meeting and simultaneously published in The New England Journal of Medicine (NEJM).

Darzalex Faspro, jointly developed by Johnson & Johnson and Genmab, is the first anti-CD38 antibody that can be administered via subcutaneous injection., reducing the treatment time for patients from several hours to just a few minutes.Darzalex Faspro was approved by the U.S. FDA in May 2020 for eight indications in multiple myeloma, three of which are for frontline treatment of newly diagnosed multiple myeloma patients, whether eligible or ineligible for transplantation.

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