{"entity":{"id":"fight-202","kind":"trial","name":"FIGHT-202","aka":[],"tldr":"FIGHT-202 is the single-arm study that produced the first targeted approval in bile duct cancer.","summary":"FIGHT-202, trial NCT02924376 sponsored by Incyte and reported in 2020, is the single-arm phase 2 study that produced the first targeted approval in bile duct cancer, for pemigatinib in previously treated cholangiocarcinoma with FGFR2 fusions. Among 147 patients, the 107 with FGFR2 fusions in cohort A had an objective response rate of about 37 percent with durable disease control, while patients with other FGF or FGFR alterations had no responses. OnCo links it to biliary tract cancer, FGFR2 as a target and pemigatinib. Without a randomised comparison the trial cannot show a survival advantage, and the first-line confirmatory trial FIGHT-302 was discontinued, so where FGFR inhibition best fits in the sequence is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02924376","url":"https://clinicaltrials.gov/study/NCT02924376"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["fgfr2"],"drugs":["pemigatinib"],"companies":["incyte"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: FIGHT-202 enrolled cholangiocarcinoma only, and the resulting licence (Pemazyre label) is for cholangiocarcinoma with an FGFR2 fusion or rearrangement; gallbladder cancer was not part of the trial or the approval population."],"nct":"NCT02924376","phase":"2","setting":"Previously treated cholangiocarcinoma with FGFR2 fusions (cohort A): pemigatinib single arm","sponsor":"Incyte","result":"ORR 37%; PFS 7.0 months; OS 17.5 months.","started":"2017-01-16","startedType":"actual","yearReported":2020,"enrolled":147,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Pemigatinib (FGFR2 fusion)","n":107,"value":35.5}],"source":"https://doi.org/10.1016/S1470-2045(20)30109-1"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Pemigatinib","value":7}],"source":"https://doi.org/10.1016/S1470-2045(20)30109-1"}]},"route":"/trials/fight-202/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"}],"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/"}],"drug":[{"id":"pemigatinib","kind":"drug","name":"Pemigatinib","route":"/drugs/pemigatinib/"}],"company":[{"id":"incyte","kind":"company","name":"Incyte","route":"/companies/incyte/"}],"idea":[{"id":"idea-btc-ctdna-fgfr-resistance","kind":"idea","name":"ctDNA-guided switching among FGFR inhibitors","route":"/ideas/idea-btc-ctdna-fgfr-resistance/"}],"paper":[{"id":"paper-fight-202-pemigatinib-lancet-oncol-2020","kind":"paper","name":"FIGHT-202: pemigatinib for previously treated cholangiocarcinoma with FGFR2 fusions or rearrangements","route":"/key-papers/paper-fight-202-pemigatinib-lancet-oncol-2020/"}]}}