Daratumumab plus VRd in Japanese transplant-ineligible/deferred NDMM patients: Japanese subgroup of the CEPHEUS trial

The phase 3 CEPHEUS trial was conducted in 13 countries starting December 11, 2018 in patients with newly diagnosed multiple myeloma (NDMM) who were transplant-ineligible or for whom transplantation was not planned as initial therapy. Bortezomib, lenalidomide, and dexamethasone (VRd) with daratumumab (D-VRd) provided deeper, more durable responses and lowered the risk of disease progression or death compared with VRd. This analysis evaluated the efficacy and safety of D-VRd specifically in the Japanese subpopulation of the CEPHEUS trial (D-VRd: n = 9; VRd: n = 13). At a median follow-up of 59.0 months, the overall minimal residual disease (MRD) negativity rate was 77.8% with D-VRd and 46.2% with VRd (odds ratio: 4.08 [95% confidence interval: 0.60, 27.65]). The complete response or better rate was 88.9% with D-VRd and 76.9% with VRd. Median progression-free survival was not reached in either group, with a hazard ratio of 0.34 favoring D-VRd. The sustained (≥ 12 months) MRD negativity rate was 55.6% with D-VRd and 38.5% with VRd. Efficacy and safety results were similar to those observed in the global CEPHEUS population, supporting the use of D-VRd in Japanese patients with NDMM.