Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients with Relapsed or Refractory Follicular Lymphoma: Final Analysis of the Phase 2 ROSEWOOD Study
In brief
Zanubrutinib plus obinutuzumab raises responses to 70% in relapsed follicular lymphoma
In this randomized phase 2 study of heavily pretreated patients, the combination produced responses in 70% versus 44% with obinutuzumab alone after a median 34.6 months of follow-up. Median progression-free survival was 22.1 versus 10.3 months, but the overall survival difference was not statistically significant; longer follow-up is needed to clarify whether the response and disease-control gains extend survival.
- Journal
- Targeted oncology (Q1)
- Published
- 3 November 2026
- Study design
- Non-randomized / quasi-experimental trial
- Evidence level
- Level 2, Moderate (CEBM 2b)
- Authors
- Pier Luigi Zinzani, David Šálek, Christopher R Flowers, Fontanet Bijou, Ana C De Oliveira, Yuqin Song, et al.
- PMID
- 42975620
- DOI
- 10.1007/s11523-026-01268-3
Why clinicians should know about it
- Picked for Hematology (paper of the day, 4 November 2026): Randomized comparison informs relapsed follicular lymphoma treatment
Abstract
BACKGROUND: 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. OBJECTIVE: To report the final analysis of ROSEWOOD with a median follow-up of 34.6 months. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03332017.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.