ROSEWOOD: a phase II randomized study of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma

A randomised phase 2 study in patients with relapsed or refractory follicular lymphoma who had received two or more lines of therapy including an anti-CD20 antibody and an alkylating agent. 217 patients were randomised 2 to 1 to zanubrutinib with obinutuzumab (145) or obinutuzumab alone (72). The primary endpoint was overall response rate by independent central review.

At a median study follow-up of 20.2 months the primary endpoint was met: overall response rate was 69 per cent with the combination against 46 per cent with obinutuzumab alone (p = 0.001). The complete response rate was 39 against 19 per cent, the 18-month duration of response rate 69 against 42 per cent, and median progression-free survival 28.0 against 10.4 months (hazard ratio 0.50, 95 per cent confidence interval 0.33 to 0.75).