{"entity":{"id":"select-lenvatinib","kind":"trial","name":"SELECT","aka":[],"tldr":"Turned lenvatinib into the main drug for thyroid cancers that no longer take up radioactive iodine, quadrupling the time before the disease grew.","summary":"SELECT, trial NCT01321554 sponsored by Eisai and reported in 2015, turned lenvatinib into the main drug for differentiated thyroid cancers that no longer take up radioactive iodine, quadrupling the time before the disease grew. It randomised 392 patients with progressive radioiodine-refractory disease to lenvatinib or placebo, met its primary progression-free survival endpoint with a very large effect and a response rate near two-thirds against almost none on placebo, leading to FDA approval in February 2015; hypertension in about two-thirds and dose reductions in more than sixty percent drive management, and survival was confounded by crossover. OnCo links it to thyroid cancer, kinase inhibitors and anti-angiogenic therapy, VEGF and RET as targets, the radioiodine-refractory term and Martin Schlumberger. When to start a drug this toxic in a slow disease is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01321554","url":"https://clinicaltrials.gov/study/NCT01321554"},{"label":"NEJM 2015","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1406470"}],"tags":[],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf","ret"],"drugs":[],"companies":["eisai"],"institutions":[],"pathways":[],"terms":["rai-refractory"],"trials":[],"people":["martin-schlumberger"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01321554","phase":"3","setting":"Radioiodine-refractory differentiated thyroid cancer with progression: lenvatinib vs placebo","sponsor":"Eisai","result":"PFS 18.3 vs 3.6 months; HR 0.21.","started":"2011-03-17","startedType":"actual","yearReported":2015,"enrolled":392,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Lenvatinib","value":18.3},{"name":"Placebo","value":3.6}],"hr":0.21,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1406470"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Lenvatinib","value":64.8},{"name":"Placebo","value":1.5}],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1406470"}],"replication":"DECISION (sorafenib) showed the same direction with a smaller effect; class effect of VEGFR multikinase inhibitors is established."},"route":"/trials/select-lenvatinib/","neighbours":{"cancer":[{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"ret","kind":"target","name":"RET","route":"/targets/ret/"},{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"company":[{"id":"eisai","kind":"company","name":"Eisai","route":"/companies/eisai/"}],"term":[{"id":"rai-refractory","kind":"term","name":"Radioiodine-refractory (RAI-R) thyroid cancer","route":"/terms/rai-refractory/"}],"person":[{"id":"martin-schlumberger","kind":"person","name":"Martin Schlumberger","route":"/people/martin-schlumberger/"}],"paper":[{"id":"paper-select-lenvatinib-nejm-2015","kind":"paper","name":"SELECT: lenvatinib versus placebo in radioiodine-refractory differentiated thyroid cancer","route":"/key-papers/paper-select-lenvatinib-nejm-2015/"}]}}