Daratumumab, bortezomib, and dexamethasone versus bortezomib and dexamethasone in Chinese patients with relapsed or refractory multiple myeloma: phase 3 LEPUS (MMY3009) study

Abstract Background Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 CASTOR study. We report the results of a prespecified interim analysis of the phase 3 LEPUS study of D-Vd versus Vd in Chinese patients with RRMM. Patients and Methods Chinese patients with ≥1 prior line of therapy were randomized 2:1 to receive 8 cycles (21 days/cycle) of bortezomib (1.3 mg/m2 subcutaneously) and dexamethasone (20 mg orally/intravenously) ± daratumumab (16 mg/kg intravenously). The primary endpoint was progression-free survival (PFS). Results 211 patients were randomized (D-Vd, 141; Vd, 70). After an 8.2-month median follow-up, D-Vd significantly prolonged PFS versus Vd (median, not reached vs 6.3 months; hazard ratio, 0.28; 95% confidence interval, 0.17-0.47; P Conclusion These data support the use of D-Vd in Chinese patients with RRMM. MicroAbstract Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the global phase 3 CASTOR study. In this phase 3 LEPUS study, among Chinese patients with RRMM (D-Vd, 141 patients; Vd, 70 patients), D-Vd demonstrated significant efficacy benefits versus Vd, and a safety profile generally consistent with that reported in CASTOR.