{"entity":{"id":"rosewood","kind":"trial","name":"ROSEWOOD","aka":["Zanubrutinib plus obinutuzumab in follicular lymphoma","ROSEWOOD trial"],"tldr":"Adding a targeted tablet to an antibody roughly doubled the chance of the lymphoma shrinking and tripled the time before it grew again, in people whose follicular lymphoma had already returned twice.","summary":"Follicular lymphoma was not a disease in which Bruton tyrosine kinase inhibitors had performed well as single agents, so ROSEWOOD tested zanubrutinib in combination with the type II anti-CD20 antibody obinutuzumab rather than alone. 217 patients with relapsed or refractory follicular lymphoma after at least two lines, including an anti-CD20 antibody and an alkylating agent, were randomised 2 to 1 to the combination (145) or to obinutuzumab alone (72).\n\nAt a median follow-up of 20.2 months the primary endpoint was met: overall response rate by independent central review was 69 per cent with the combination against 46 per cent with obinutuzumab alone (p = 0.001). Complete response 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 months against 10.4 (hazard ratio 0.50, 95 per cent confidence interval 0.33 to 0.75).\n\nIt is a randomised phase 2, so the comparator is an antibody that few would use alone in this setting, and the result establishes activity rather than a place in a sequence. It is nonetheless the clearest evidence that the Bruton tyrosine kinase pathway is worth attacking in follicular lymphoma when the antibody is a type II one.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT03332017","url":"https://clinicaltrials.gov/study/NCT03332017"},{"label":"Journal of Clinical Oncology 2023","url":"https://doi.org/10.1200/JCO.23.00775"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["targeted-therapy","immunotherapy"],"technologies":["monoclonal-antibody"],"targets":["btk","cd20"],"drugs":["zanubrutinib","obinutuzumab"],"companies":[],"institutions":[],"pathways":["bcr-signalling"],"terms":["orr","complete-response"],"trials":[],"people":[],"bottlenecks":["b-combination-space"],"keyPapers":["paper-rosewood-zanubrutinib-obinutuzumab-follicular-jco-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03332017","phase":"2","setting":"Relapsed or refractory follicular lymphoma after two or more lines including an anti-CD20 antibody and an alkylating agent: zanubrutinib with obinutuzumab against obinutuzumab alone","sponsor":"BeiGene","result":"Overall response 69 against 46 per cent (p = 0.001) and median progression-free survival 28.0 against 10.4 months (hazard ratio 0.50).","started":"2017-11-14","startedType":"actual","yearReported":2023,"enrolled":217,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate by independent central review","primary":true,"unit":"%","arms":[{"name":"Zanubrutinib with obinutuzumab","n":145,"value":69},{"name":"Obinutuzumab alone","n":72,"value":46}],"p":"0.001","source":"https://doi.org/10.1200/JCO.23.00775"},{"endpoint":"Progression-free survival (median)","unit":"months","arms":[{"name":"Zanubrutinib with obinutuzumab","n":145,"value":28},{"name":"Obinutuzumab alone","n":72,"value":10.4}],"hr":0.5,"ci":[0.33,0.75]}],"replication":"Not replicated; the comparator arm was obinutuzumab monotherapy rather than a combination in common use."},"route":"/trials/rosewood/","neighbours":{"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/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"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/"}],"bottleneck":[{"id":"b-combination-space","kind":"bottleneck","name":"Too many combinations to test","route":"/bottlenecks/b-combination-space/"}],"paper":[{"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","route":"/key-papers/paper-rosewood-zanubrutinib-obinutuzumab-follicular-jco-2023/"}],"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/"}],"trial":[{"id":"nct04680052","kind":"trial","name":"A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Pa","route":"/trials/nct04680052/"}]}}