ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

作者：Zinzani, Pier Luigi^*; Mayer, Jiri; Flowers, Christopher R.; Bijou, Fontanet; De Oliveira, Ana C.; Song, Yuqin; Zhang, Qingyuan; Merli, Michele; Bouabdallah, Krimo; Ganly, Peter; Zhang, Huilai; Johnson, Roderick; Martin Garcia-Sancho, Alejandro; Provencio Pulla, Mariano; Trneny, Marek; Yuen, Sam; Tilly, Herve; Kingsley, Edwin; Tumyan, Gayane; Assouline, Sarit E.; Auer, Rebecca; Ivanova, Elena; Kim, Pil; Huang, Sha; Delarue, Richard; Trotman, Judith

来源：Journal of Clinical Oncology, 2023, 41(33): 5107-+.

DOI：10.1200/JCO.23.00775

• NON-HODGKIN-LYMPHOMA
• CHRONIC LYMPHOCYTIC-LEUKEMIA
• OPEN-LABEL
• RITUXIMAB
• MULTICENTER
• COPANLISIB
• INHIBITION
• IBRUTINIB
• SURVIVAL
• GA101

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 A total of 217 patients were randomized (ZO, 145; O, 72). Median study follow-up was 20.2 months. The study met its primary end point: ORR by ICR was 69% (ZO) versus 46% (O; P = .001). Complete response rate was 39% (ZO) versus 19% (O); 18-month DOR rate was 69% (ZO) versus 42% (O). Median PFS was 28.0 months (ZO) versus 10.4 months (O; hazard ratio, 0.50 [95% CI, 0.33 to 0.75]; P < .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.

• 单位
  哈尔滨医科大学; 河南工业大学; i