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

ZINZANI, Pier Luigi, Jiří MAYER, Christopher R FLOWERS, Fontanet BIJOU, Ana C De OLIVEIRA, Yuqin SONG, Qingyuan ZHANG, Michele MERLI, Krimo BOUABDALLAH, Peter GANLY, Huilai ZHANG, Roderick JOHNSON, Alejandro Martín GARCÍA-SANCHO, Mariano Provencio PULLA, Marek TRNĚNÝ, Sam YUEN, Herve TILLY, Edwin KINGSLEY, Gayane TUMYAN, Sarit E ASSOULINE, Rebecca AUER, Elena IVANOVA, Pil KIM, Sha HUANG, Richard DELARUE and Judith TROTMAN. ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma. Journal of Clinical Oncology. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS, 2023, vol. 41, No 33, p. 5107-5117, 13 pp. ISSN 0732-183X. Available from: https://dx.doi.org/10.1200/JCO.23.00775.

Basic information

• Original name: ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
• Authors: ZINZANI, Pier Luigi, Jiří MAYER (203 Czech Republic, belonging to the institution), Christopher R FLOWERS, Fontanet BIJOU, Ana C De OLIVEIRA, Yuqin SONG, Qingyuan ZHANG, Michele MERLI, Krimo BOUABDALLAH, Peter GANLY, Huilai ZHANG, Roderick JOHNSON, Alejandro Martín GARCÍA-SANCHO, Mariano Provencio PULLA, Marek TRNĚNÝ, Sam YUEN, Herve TILLY, Edwin KINGSLEY, Gayane TUMYAN, Sarit E ASSOULINE, Rebecca AUER, Elena IVANOVA, Pil KIM, Sha HUANG, Richard DELARUE and Judith TROTMAN.
• Edition: Journal of Clinical Oncology, PHILADELPHIA, LIPPINCOTT WILLIAMS & WILKINS, 2023, 0732-183X.

Other information

• Original language: English
• Type of outcome: Article in a journal
• Field of Study: 30205 Hematology
• Country of publisher: United States of America
• Confidentiality degree: is not subject to a state or trade secret
• WWW: URL
• Impact factor: Impact factor: 45.300 in 2022
• RIV identification code: RIV/00216224:14110/23:00132497
• Organization unit: Faculty of Medicine
• Doi: http://dx.doi.org/10.1200/JCO.23.00775
• UT WoS: 001112781400018
• Keywords in English: Zanubrutinib; Obinutuzumab; Refractory Follicular Lymphoma
• Tags: 14110212, rivok
• Tags: International impact, Reviewed

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: 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.