Multicenter phase 3 trial of first-line zuberitamab plus CHOP versus rituximab plus CHOP for CD20-positive diffuse large B-cell lymphoma

A multicenter phase 3 trial in China compared first-line zuberitamab (rituximab biosimilar) plus CHOP (Hi-CHOP) versus rituximab plus CHOP (R-CHOP) for CD20-positive DLBCL. In the per-protocol set, Hi-CHOP was noninferior to R-CHOP regarding objective response rate (95.3% versus 93.7%) and exhibited higher complete response rate (85.7% versus 77.3%; p=0.038). At median follow-up of 29.6 months, the Hi-CHOP group had a slight advantage with regard to duration of response, progression-free survival, event-free survival, and overall survival. Patients with the germinal-center B-cell like subtype who received Hi-CHOP had statistically significant improvements in ORR, CR, EFS, and OS. Treatment-emergent adverse events rates was comparable across groups, with exception of grade 1-3 infusion-related reactions (32.1% with Hi-CHOP versus 19.9% with R-CHOP; p=0.006). The authors conclude that Hi-CHOP was non-inferior to R-CHOP in terms of ORR and resulted in higher CR rate and was well tolerated in previously untreated CD20-positive DLBCL.