ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
Pier Luigi Zinzani, Jiřı́ Mayer, Christopher R. Flowers, Fontanet Bijou, Ana Carla Oliveira, Yuqin Song, Qingyuan Zhang, Michele Merli, Krimo Bouabdallah, Peter Ganly, Huilai Zhang, Roderick J. Johnson, Alejandro Martı́n, Mariano Provencio, Marek Trněný, Sam Yuen, Hervé Tilly, Edwin Kingsley, Gayane Tumyan, Sarit Assouline, Rebecca Auer, Elena V. Ivanova, Pil Kim, Sha Huang, Richard Delarue, Judith Trotman
Abstract
PURPOSE: The combination of zanubrutinib plus obinutuzumab (ZO) was found to be well tolerated with an early signal of efficacy in a phase Ib study. ROSEWOOD is a phase II, randomized study that assessed the efficacy and safety of ZO versus obinutuzumab in patients with relapsed/refractory (R/R) follicular lymphoma (FL). METHODS: Patients with R/R FL who had received ≥2 lines of therapy, including an anti-CD20 antibody and an alkylating agent, were randomly assigned 2:1 to receive ZO or obinutuzumab (O). The primary end point was overall response rate (ORR) by independent central review (ICR). Secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival, and safety. RESULTS: < .001). The most common adverse events with ZO were thrombocytopenia, neutropenia, diarrhea, and fatigue; incidences of atrial fibrillation and major hemorrhage were 3% and 1%, respectively. CONCLUSION: The combination of ZO met its primary end point of a superior ORR versus O, and demonstrated meaningful activity and a manageable safety profile in patients with R/R FL. ZO had a favorable benefit-risk profile compared with O, and represents a potential combination therapy for patients with R/R FL.