J&J says Phase 3 CEPHEUS study meets primary endpoint

Johnson & Johnson announced results from the Phase 3 CEPHEUS study demonstrating a significant clinical improvement with DARZALEX FASPRO in combination with bortezomib, lenalidomide and dexamethasone in the treatment of patients with newly diagnosed multiple myeloma who are transplant ineligible or for whom transplant was not planned as initial therapy. The data showing significant improvement in minimal residual disease negativity rate, progression-free survival and complete response or better rate, were featured as a late-breaking oral presentation at the 2024 International Myeloma Society Annual Meeting. CEPHEUS is an ongoing, multicenter, randomized, open-label, Phase 3 study evaluating the efficacy and safety of D-VRd compared to bortezomib, lenalidomide and dexamethasone for NDMM patients for whom transplant was not planned as initial therapy. Results show that treatment with D-VRd resulted in deeper responses, including MRD-negativity, compared with VRd. At a median follow-up of 58.7 months, the primary endpoint was met, with overall MRD-negativity rate at a sensitivity of 10-5 of 60.9 percent for patients receiving D-VRd and 39.4 percent for VRd. The proportion of patients achieving sustained MRD-negativity of greater than or equal to 12 months almost doubled with D-VRd vs VRd. The study also demonstrated that D-VRd significantly reduced the risk of progression or death by 43 percent vs VRd. The median PFS was not reached for D-VRd vs 52.6 months for VRd. The DARZALEX FASPRO-based quadruplet regimen, compared to VRd, also significantly increased the depth of response with higher rates of CR or better. The CR or better rate was 81.2 percent with D-VRd vs 61.6 percent with VRd. Overall survival data are not yet mature. The overall safety profile of D-VRd was consistent with the known safety profiles for DARZALEX FASPRO(R) and VRd.