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.