Filing at FDA for Darzalex Faspro-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned

This submission is supported by data from the Phase III CEPHEUS study (NCT03652064), which showed 60.9 percent of patients achieved minimal residual disease (MRD)-negativity with D-VRd and the risk of progression or death was reduced by 43 percent. The CEPHEUS study evaluated the efficacy and safety of D-VRd compared to bortezomib, lenalidomide and dexamethasone (VRd) for NDMM patients for whom ASCT was not planned as initial therapy (transplant ineligible or deferred).

The D-VRd regimen increased depth and durability of responses compared to VRd, including the primary endpoint of overall MRD-negativity rate (10^-) of 60.9 percent vs 39.4 percent at a median follow-up of 58.7 months (odds ratio [OR], 2.37; 95% confidence interval [CI], 1.58-3.55; P<0.0001). The sustained MRD-negativity rate favored D-VRd 48.7 percent vs 26.3 percent for VRd (P<0.0001). The study also demonstrated that D-VRd significantly reduced the risk of progression or death by 43 percent (hazard ratio, 0.57; 95% CI, 0.41-0.79; P<0.0005) vs VRd and achieved an overall complete response (CR) or better rate of 81.2 percent with D-VRd vs 61.6 percent with VRd (P<0.0001). The overall safety profile of D-VRd was consistent with the known safety profiles for Darzalex Faspro and VRd.

Data from CEPHEUS was presented as a late-breaking oral presentation (Abstract #OA-63) at the 2024 International Multiple Myeloma Society (IMS) Annual Meeting.