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Interim Analysis of Phase III Trial of Combination Therapies for Resistant Myeloma

By: Kayci Reyer
Posted: Thursday, July 22, 2021

A combination therapy of the monoclonal antibody daratumumab and the proteasome inhibitor bortezomib plus the corticosteroid dexamethasone may result in substantially improved outcomes for some patients with relapsed or refractory multiple myeloma compared with bortezomib/dexamethasone alone, suggested research presented in Clinical Lymphoma, Myeloma, & Leukemia. In the phase III LEPUS study, Xiaojun Huang, MD, PhD, of Peking University People’s Hospital in Beijing, and colleagues investigated the results of this combination treatment versus bortezomib/dexamethasone alone in a population of Chinese patients.

The study included 211 patients who were randomly assigned 2:1 to receive 8 cycles of either 1.3 mg/m2 of subcutaneous bortezomib and 20 mg of oral or intravenous dexamethasone with (n = 141) or without (n = 70) 16 mg/kg of intravenous daratumumab. At a median follow-up of 8.2 months, median progression-free survival was superior with daratumumab (not reached vs. 6.3 months). The daratumumab group also experienced significantly higher rates of overall response (83% vs. 65%), very good partial response or better (65% vs. 33%), complete response or better (33% vs. 11%), and minimal residual disease negativity (10-5 sensitivity; 22% vs. 3%). Progression-free survival superiority was maintained across all predetermined patient subgroups within the daratumumab cohort.

Grade 3 or 4 lymphopenia and infections occurred more often for patients in both groups of the LEPUS study than for those in the previous global phase III CASTOR study. However, the overall safety profile was comparable to the safety profile observed in the CASTOR study. In the LEPUS study, the most common grade 3 or 4 treatment-related adverse events included thrombocytopenia (with daratumumab, 51%; without, 37%), lymphopenia (with daratumumab, 44%; without, 29%), and lung infection (with daratumumab, 30%; without, 22%).

Disclosure: For full disclosures of the study authors, visit

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