{"entity":{"id":"goya","kind":"trial","name":"GOYA","aka":["Obinutuzumab versus rituximab in first-line diffuse large B-cell lymphoma","GOYA trial"],"tldr":"A newer antibody against the same target as rituximab was tested in first-line treatment for the commonest aggressive lymphoma and did not work better, while causing more side effects.","summary":"Obinutuzumab is a glycoengineered type II anti-CD20 antibody that had already beaten rituximab on progression-free survival in chronic lymphocytic leukaemia and in follicular lymphoma (GALLIUM). GOYA tested the same substitution in untreated advanced diffuse large B-cell lymphoma, randomising 1,418 patients to eight 21-day cycles of obinutuzumab (706) or rituximab (712) with six or eight cycles of CHOP.\n\nAfter a median observation of 29 months the investigator-assessed progression-free survival events were almost identical, 201 (28.5 per cent) with obinutuzumab and 215 (30.2 per cent) with rituximab, a stratified hazard ratio of 0.92 (95 per cent confidence interval 0.76 to 1.11, p = 0.39), with three-year rates of 70 and 67 per cent. Independently reviewed progression-free survival, the other time-to-event endpoints and response rates were all similar. Grade 3 to 5 adverse events were more frequent with obinutuzumab (73.7 against 64.7 per cent), as were serious adverse events (42.6 against 37.6 per cent) and fatal events (5.8 against 4.3 per cent).\n\nGOYA matters because it broke the assumption that an antibody improvement carries across B-cell lymphomas. The exploratory finding that germinal-centre B-cell tumours did better than activated B-cell tumours irrespective of treatment is the clearest signal the trial left behind, and it points at the genetic subtype work rather than at the antibody. The registry lists the study as terminated, which reflects the end of a programme that did not continue rather than a safety stop.","status":"negative","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT01287741","url":"https://clinicaltrials.gov/study/NCT01287741"},{"label":"Journal of Clinical Oncology 2017","url":"https://doi.org/10.1200/JCO.2017.73.3402"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":["immunotherapy","chemotherapy"],"technologies":["monoclonal-antibody"],"targets":["cd20"],"drugs":["obinutuzumab","rituximab","cyclophosphamide","doxorubicin","vincristine","prednisone"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["r-chop","cell-of-origin"],"trials":["gallium"],"people":["laurie-sehn"],"bottlenecks":["b-negative-results","b-biomarker-validation"],"keyPapers":["paper-goya-obinutuzumab-vs-rituximab-chop-dlbcl-jco-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01287741","phase":"3","setting":"Untreated advanced diffuse large B-cell lymphoma: obinutuzumab with CHOP against rituximab with CHOP","sponsor":"Hoffmann-La Roche","result":"Progression-free survival hazard ratio 0.92 (p = 0.39): no benefit over rituximab, with more grade 3 to 5 and fatal adverse events.","started":"2011-07-26","startedType":"actual","yearReported":2017,"enrolled":1418,"enrolledBasis":"registry","outcomes":[{"endpoint":"Investigator-assessed progression-free survival","primary":true,"arms":[{"name":"Obinutuzumab with CHOP","n":706,"note":"three-year rate 70 per cent"},{"name":"Rituximab with CHOP","n":712,"note":"three-year rate 67 per cent"}],"hr":0.92,"ci":[0.76,1.11],"p":"0.39","source":"https://doi.org/10.1200/JCO.2017.73.3402"}],"replication":"The opposite result to GALLIUM in follicular lymphoma, which is the point: the two diseases did not behave alike."},"route":"/trials/goya/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"drug":[{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"obinutuzumab","kind":"drug","name":"Obinutuzumab","route":"/drugs/obinutuzumab/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"},{"id":"vincristine","kind":"drug","name":"Vincristine","route":"/drugs/vincristine/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"cell-of-origin","kind":"term","name":"Cell of origin (GCB vs ABC)","route":"/terms/cell-of-origin/"},{"id":"r-chop","kind":"term","name":"R-CHOP (lymphoma chemoimmunotherapy)","route":"/terms/r-chop/"}],"trial":[{"id":"gallium","kind":"trial","name":"GALLIUM","route":"/trials/gallium/"},{"id":"polarix","kind":"trial","name":"POLARIX","route":"/trials/polarix/"}],"person":[{"id":"laurie-sehn","kind":"person","name":"Laurie H. Sehn","route":"/people/laurie-sehn/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"}],"paper":[{"id":"paper-goya-obinutuzumab-vs-rituximab-chop-dlbcl-jco-2017","kind":"paper","name":"Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large B-cell lymphoma","route":"/key-papers/paper-goya-obinutuzumab-vs-rituximab-chop-dlbcl-jco-2017/"}],"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/"}]}}