Study of the first and only subcutaneous quadruplet regimen demonstrates 60.9 percent improvement in minimal residual disease (MRD)-negativity and 43 percent reduction in the risk of progression or death Phase 3 CEPHEUS study results presented in late-breaking oral presentation at the International Myeloma Society (IMS) Annual Meeting RIO DE JANEIRO , Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ ) announced today results from the Phase 3 CEPHEUS study demonstrating a significant clinical improvement with DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) in the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are transplant ineligible (TIE) or for whom transplant was not planned as initial therapy (transplant deferred).
The data showing significant improvement in minimal residual disease (MRD) negativity rate, progression-free survival (PFS) and complete response (CR) or better rate, were featured as a late-breaking oral presentation at the 2024 International Myeloma Society (IMS) Annual Meeting (Abstract #OA — 63). 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 (VRd) for NDMM patients for whom transplant was not planned as initial therapy (TIE or deferred). Results show that treatment with D-VRd resulted in deeper responses, including MRD.