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

医学 奥比努图库单抗 内科学 中性粒细胞减少症 临床终点 胃肠病学 危险系数 临床研究阶段 不利影响 美罗华 外科 随机对照试验 淋巴瘤 化疗 置信区间
作者
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 Johnson,Alejandro Martín García-Sancho,M. Provencio Pulla,Marek Trněný,Sam Yuen,Hervé Tilly,Edwin C. Kingsley,Gayane Tumyan,Sarit Assouline,Rebecca Auer,Elena Ivanova,Pil Kim,Sha Huang,Richard Delarue,Judith Trotman
出处
期刊:Journal of Clinical Oncology [American Society of Clinical Oncology]
卷期号:41 (33): 5107-5117 被引量:10
标识
DOI:10.1200/jco.23.00775
摘要

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).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.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.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.
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