Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients with Relapsed or Refractory Follicular Lymphoma: Final Analysis of the Phase 2 ROSEWOOD Study

In the primary analysis of the phase 2 ROSEWOOD trial, combination zanubrutinib and obinutuzumab (ZO) demonstrated superior overall response rate (ORR) and progression-free survival (PFS) compared with obinutuzumab monotherapy (O) in patients with relapsed/refractory follicular lymphoma (R/R FL) who had received ≥ 2 prior lines of therapy. To report the final analysis of ROSEWOOD with a median follow-up of 34.6 months. Patients with R/R FL were randomised 2:1 to receive ZO or O. Efficacy endpoints included ORR, duration of response (DoR), PFS, overall survival (OS) and time to next anticancer therapy or crossover (TTNT); safety was also assessed. ZO maintained superior ORR versus O (70.3% versus 44.4%; risk difference, 25.5% [95% CI: 11.8–39.3%; P = 0.0003]) and higher complete response rate (42.1% versus 19.4%). Efficacy findings across patient subgroups were generally consistent with the overall population. Median DoR and PFS were longer with ZO than O (DoR, 32.9 versus 14.0 months; PFS, 22.1 versus 10.3 months), as was median TTNT (51.7 versus 12.1 months). The OS comparison did not reach statistical significance (hazard ratio, 0.66; 95% CI, 0.43–1.04%). The safety profile of ZO was manageable and consistent with known effects of both drugs, with no new safety signals. With nearly 3 years of follow-up, these updated results support a favourable risk-benefit profile of ZO in heavily pretreated patients with R/R FL. ClinicalTrials.gov identifier: NCT03332017.

Authors

Institutions

Publication Details

Journal
Targeted Oncology
Published
2026-11-03
DOI
https://doi.org/10.1007/s11523-026-01268-3
Primary Topic
Lymphoma Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients with Relapsed or Refractory Follicular Lymphoma: Final Analysis of the Phase 2 ROSEWOOD Study

Rebecca L. Auer, Sam Yuen, Marco Brociner, Peter S. Ganly et al.
Targeted Oncology
Lymphoma Diagnosis and Treatment
article

Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients with Relapsed or Refractory Follicular Lymphoma: Final Analysis of the Phase 2 ROSEWOOD Study

Rebecca L. Auer, Sam Yuen, Marco Brociner, Peter S. Ganly, Roderick J. Johnson, Jamie H. Hirata, Krimo K. Bouabdallah, Fontanet Delices Bijou, Judith Trotman, Christopher R. Flowers, Marek Trněný, Pier Luigi Zinzani, David Šálek, Sha Huang, Mariano Provencio Pulla, Ana C. de Oliveira, Alejandro Martín García-Sancho, Qingyuan Zhang, Jiayi Shen, Huilai Zhang, Yuqin Song
article en

Abstract

In the primary analysis of the phase 2 ROSEWOOD trial, combination zanubrutinib and obinutuzumab (ZO) demonstrated superior overall response rate (ORR) and progression-free survival (PFS) compared with obinutuzumab monotherapy (O) in patients with relapsed/refractory follicular lymphoma (R/R FL) who had received ≥ 2 prior lines of therapy. To report the final analysis of ROSEWOOD with a median follow-up of 34.6 months. Patients with R/R FL were randomised 2:1 to receive ZO or O. Efficacy endpoints included ORR, duration of response (DoR), PFS, overall survival (OS) and time to next anticancer therapy or crossover (TTNT); safety was also assessed. ZO maintained superior ORR versus O (70.3% versus 44.4%; risk difference, 25.5% [95% CI: 11.8–39.3%; P = 0.0003]) and higher complete response rate (42.1% versus 19.4%). Efficacy findings across patient subgroups were generally consistent with the overall population. Median DoR and PFS were longer with ZO than O (DoR, 32.9 versus 14.0 months; PFS, 22.1 versus 10.3 months), as was median TTNT (51.7 versus 12.1 months). The OS comparison did not reach statistical significance (hazard ratio, 0.66; 95% CI, 0.43–1.04%). The safety profile of ZO was manageable and consistent with known effects of both drugs, with no new safety signals. With nearly 3 years of follow-up, these updated results support a favourable risk-benefit profile of ZO in heavily pretreated patients with R/R FL. ClinicalTrials.gov identifier: NCT03332017.

Targeted Oncology
The University of Sydney (AU), St Bartholomew's Hospital (GB), The University of Texas MD Anderson Cancer Center (US), Universidad de Salamanca (ES), Barts Health NHS Trust (GB), Leeds Teaching Hospitals NHS Trust (GB), Concord Repatriation General Hospital (AU), St James's University Hospital (GB), Ospedale di Circolo e Fondazione Macchi (IT), Tianjin Medical University Cancer Institute and Hospital (CN), Christchurch Hospital (NZ), Centre Hospitalier Universitaire de Bordeaux (FR), Peking University Cancer Hospital (CN), University Hospital Brno (CZ), Third Affiliated Hospital of Harbin Medical University (CN), Hospital Universitario Puerta de Hierro Majadahonda (ES), Istituto di Ematologia di Bologna (IT), Azienda USL di Bologna (IT), Hôpital Cardiologique du Haut-Lévêque (FR), Instituto de Investigación Biomédica de Salamanca (ES), Institut Bergonié (FR), Centro de Investigación del Cáncer (ES), Duran i Reynals Hospital (ES), Calvary Mater Newcastle Hospital (AU), Centro de Investigación Biomédica en Red de Cáncer (ES), General University Hospital in Prague (CZ), Instituto de Biología Molecular y Celular del Cáncer de Salamanca (ES), BeOne Medicines (Switzerland) (CH)
Openalex Percentile: Top 14%
Lymphoma Diagnosis and Treatment
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.

Laika access coming soon