{"entity":{"id":"thor","kind":"trial","name":"THOR","aka":[],"tldr":"The first targeted pill to lengthen survival in bladder cancer, for the fifth of tumours with FGFR alterations.","summary":"THOR, trial NCT03390504 sponsored by Johnson & Johnson and reported in 2023, produced the first targeted tablet to lengthen survival in bladder cancer, for the fifth of advanced urothelial tumours with FGFR alterations. Cohort 1 randomised 266 patients with FGFR3 or FGFR2 alterations after chemotherapy and a checkpoint inhibitor to erdafitinib or chemotherapy and met its primary overall survival endpoint with a clear benefit, while cohort 2, against pembrolizumab in immunotherapy-naive patients, showed no benefit, so erdafitinib is positioned after immunotherapy; full FDA approval followed in January 2024. OnCo links it to bladder cancer, FGFR2 as a target, erdafitinib and the FGFR3 alterations term, and THOR-2 explored intravesical and oral use in non-muscle-invasive disease. Whether FGFR inhibitors can be combined with immunotherapy rather than sequenced after it is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03390504","url":"https://clinicaltrials.gov/study/NCT03390504"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["fgfr2"],"drugs":["erdafitinib"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["fgfr3"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03390504","phase":"3","setting":"Advanced urothelial cancer with FGFR3/2 alterations after chemotherapy and a checkpoint inhibitor: erdafitinib vs chemotherapy (cohort 1)","sponsor":"Johnson & Johnson","result":"OS 12.1 vs 7.8 months, HR 0.64 (cohort 1).","started":"2018-03-23","startedType":"actual","yearReported":2023,"enrolled":266,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (cohort 1)","primary":true,"unit":"months","arms":[{"name":"Erdafitinib","n":136,"value":12.1},{"name":"Chemotherapy","n":130,"value":7.8}],"hr":0.64,"ci":[0.47,0.88],"p":"0.005","source":"https://ascopubs.org/doi/10.1200/JCO.2023.41.17_suppl.LBA4619"}],"replication":"Cohort 2 (vs pembrolizumab) negative; benefit confined to the post-IO setting."},"route":"/trials/thor/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"fgfr2","kind":"target","name":"FGFR2","route":"/targets/fgfr2/"},{"id":"fgfr3-receptor","kind":"target","name":"FGFR3","route":"/targets/fgfr3-receptor/"}],"drug":[{"id":"erdafitinib","kind":"drug","name":"Erdafitinib","route":"/drugs/erdafitinib/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"term":[{"id":"fgfr3","kind":"term","name":"FGFR3 alterations (bladder cancer)","route":"/terms/fgfr3/"}]}}