Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large B-cell lymphoma

A randomised phase 3 trial in which 1,418 patients with previously untreated advanced diffuse large B-cell lymphoma received eight 21-day cycles of obinutuzumab (706) or rituximab (712) with six or eight cycles of CHOP. The primary endpoint was investigator-assessed progression-free survival.

After a median observation of 29 months there were 201 progression-free survival events (28.5 per cent) with obinutuzumab and 215 (30.2 per cent) with rituximab, a stratified hazard ratio of 0.92 (95 per cent confidence interval 0.76 to 1.11, p = 0.39), with three-year rates of 70 and 67 per cent. Independently reviewed progression-free survival, other time-to-event endpoints and response rates were similar. Grade 3 to 5 adverse events occurred in 73.7 against 64.7 per cent, serious adverse events in 42.6 against 37.6 per cent and fatal adverse events in 5.8 against 4.3 per cent. In exploratory analysis, patients with germinal-centre B-cell subtype disease had better progression-free survival than those with activated B-cell subtype disease irrespective of treatment.