{"entity":{"id":"paper-rosewood-zanubrutinib-obinutuzumab-follicular-jco-2023","kind":"paper","name":"ROSEWOOD: a phase II randomized study of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma","aka":["ROSEWOOD","Zinzani 2023"],"tldr":"Adding a targeted tablet to an antibody roughly halved the risk of progression in follicular lymphoma that had already returned twice.","summary":"A randomised phase 2 study in patients with relapsed or refractory follicular lymphoma who had received two or more lines of therapy including an anti-CD20 antibody and an alkylating agent. 217 patients were randomised 2 to 1 to zanubrutinib with obinutuzumab (145) or obinutuzumab alone (72). The primary endpoint was overall response rate by independent central review.\n\nAt a median study follow-up of 20.2 months the primary endpoint was met: overall response rate was 69 per cent with the combination against 46 per cent with obinutuzumab alone (p = 0.001). The complete response rate was 39 against 19 per cent, the 18-month duration of response rate 69 against 42 per cent, and median progression-free survival 28.0 against 10.4 months (hazard ratio 0.50, 95 per cent confidence interval 0.33 to 0.75).","asOf":"2026-10-01","links":[{"label":"Journal of Clinical Oncology 2023","url":"https://doi.org/10.1200/JCO.23.00775"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37506346/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/37506346"}],"tags":["lymphoma-evidence"],"related":["lymphoma-roadmap"],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["targeted-therapy","immunotherapy"],"technologies":[],"targets":["btk","cd20"],"drugs":["zanubrutinib","obinutuzumab"],"companies":[],"institutions":[],"pathways":["bcr-signalling"],"terms":["orr","complete-response"],"trials":["rosewood"],"people":[],"bottlenecks":["b-combination-space"],"keyPapers":[],"journals":["jco"],"dependsOn":[],"notes":[],"journal":"Journal of Clinical Oncology","year":2023,"doi":"10.1200/JCO.23.00775","pmid":"37506346","authors":"Zinzani PL, Mayer J, Flowers CR, et al.","paperType":"rct","findings":["Overall response rate by independent central review was 69 per cent with zanubrutinib and obinutuzumab against 46 per cent with obinutuzumab alone (p = 0.001).","Complete response rate was 39 per cent against 19 per cent.","The 18-month duration of response rate was 69 per cent against 42 per cent.","Median progression-free survival was 28.0 months against 10.4 months (hazard ratio 0.50, 95 per cent confidence interval 0.33 to 0.75)."],"whatItMeans":"Evidence that the B-cell receptor pathway is worth attacking in follicular lymphoma when a Bruton tyrosine kinase inhibitor is paired with a type II CD20 antibody, after single-agent inhibitors had disappointed in this disease.","caveats":["A randomised phase 2, not a phase 3: the result establishes activity rather than a position in a treatment sequence.","Obinutuzumab monotherapy is not a standard comparator in this setting, which inflates the apparent difference.","Median follow-up of 20.2 months, with no overall survival result."],"changedPractice":true,"participants":217},"route":"/key-papers/paper-rosewood-zanubrutinib-obinutuzumab-follicular-jco-2023/","neighbours":{"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"cancer":[{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"}],"section":[{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"},{"id":"targeted-therapy","kind":"section","name":"Targeted Therapy","route":"/fronts/targeted-therapy/"}],"target":[{"id":"btk","kind":"target","name":"BTK (Bruton tyrosine kinase)","route":"/targets/btk/"},{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"drug":[{"id":"obinutuzumab","kind":"drug","name":"Obinutuzumab","route":"/drugs/obinutuzumab/"},{"id":"zanubrutinib","kind":"drug","name":"Zanubrutinib","route":"/drugs/zanubrutinib/"}],"pathway":[{"id":"bcr-signalling","kind":"pathway","name":"B-cell receptor / BTK signalling (to NF-κB)","route":"/pathways/bcr-signalling/"}],"term":[{"id":"complete-response","kind":"term","name":"Complete response","route":"/terms/complete-response/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"}],"trial":[{"id":"rosewood","kind":"trial","name":"ROSEWOOD","route":"/trials/rosewood/"}],"bottleneck":[{"id":"b-combination-space","kind":"bottleneck","name":"Too many combinations to test","route":"/bottlenecks/b-combination-space/"}],"journal":[{"id":"jco","kind":"journal","name":"Journal of Clinical Oncology","route":"/journals/jco/"}]}}