Johnson & Johnson (JNJ) has announced the results from the Phase 3 CEPHEUS study, highlighting a notable clinical enhancement achieved with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) when used in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for treating newly diagnosed multiple myeloma (NDMM) in patients who are either ineligible for transplant (TIE) or for whom transplant was not initially planned (transplant deferred). The study's data indicated significant improvements in minimal residual disease (MRD) negativity rates, progression-free survival (PFS), and complete response (CR) rates or better.
At a median follow-up of 58.7 months, the primary endpoint was achieved, with an overall MRD-negativity rate at a sensitivity of 10^-5 (no cancer cells detected within 100,000 bone marrow cells) standing at 60.9 percent for patients receiving D-VRd, compared to 39.4 percent for those on VRd alone. The study further demonstrated that D-VRd substantially reduced the risk of disease progression or death by 43 percent compared to VRd. While the median progression-free survival was not reached for patients on D-VRd, it was recorded at 52.6 months for those on VRd.
The DARZALEX FASPRO-based quadruplet regimen also significantly enhanced the depth of response, yielding higher rates of CR or better. The CR or better rate reached 81.2 percent with D-VRd, as opposed to 61.6 percent with VRd. While the data on overall survival are not yet mature, the safety profile of D-VRd remains consistent with the known safety profiles of DARZALEX FASPRO and VRd.
