{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T13:32:43Z","timestamp":1791898363733,"version":"4.3.4"},"reference-count":25,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"23","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,8,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Cholangiocarcinoma is a rare cancer associated with poor prognosis. Pemigatinib was the first FGFR1-3 inhibitor approved for second-line therapy and beyond, on the basis of the phase II FIGHT-202 trial. Here, we assess efficacy and safety of first-line pemigatinib.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      FIGHT-302 is a phase III, randomized, global trial evaluating pemigatinib as first-line therapy (ClinicalTrials.gov identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT03656536\">NCT03656536<\/jats:ext-link>\n                      ). Adults with advanced cholangiocarcinoma with\n                      <jats:italic toggle=\"yes\">FGFR2<\/jats:italic>\n                      rearrangement were randomized 1:1 to receive pemigatinib (13.5 mg once daily) or chemotherapy (1,000 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      gemcitabine plus 25 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      cisplatin once per day on days 1 and 8 of every 3-week cycle for \u22648 cycles) and were stratified by prior receipt of chemotherapy, geographic region, and tumor burden. Pemigatinib crossover was allowed for patients progressing on chemotherapy. The primary end point was progression-free survival (PFS). Secondary efficacy, safety, and exploratory end points were also analyzed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Overall, 4,563 patients were prescreened, 196 were screened, and 167 randomly assigned to receive pemigatinib (n = 83) or chemotherapy (n = 84) before early closure of the study because of a change in standard of care. The median PFS was 8.3 months in the pemigatinib group versus 6.8 months in the chemotherapy group (hazard ratio, 0.58 [95% CI, 0.39 to 0.87]; nominal\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .0078); objective response rate was 47% versus 15%, and the median duration of response was 14.2 versus 6.3 months. Median overall survival was similar (24.4\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      25.0 months, respectively). In the crossover group (n = 42, second-line pemigatinib), the median PFS was 8.1 months. Safety was consistent with the known profile of pemigatinib.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>\n                      To our knowledge, this was the largest, first-line, randomized, phase III trial of a targeted therapy for advanced\n                      <jats:italic toggle=\"yes\">FGFR2-<\/jats:italic>\n                      rearranged cholangiocarcinoma. Pemigatinib demonstrated prolonged median PFS compared with chemotherapy, with no new safety findings.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-26-00788","type":"journal-article","created":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T11:59:10Z","timestamp":1780315150000},"page":"2187-2197","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":10,"title":["Pemigatinib for Unresectable or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor\u20132 Rearrangement: Results From the Phase III FIGHT-302 Trial"],"prefix":"10.1200","volume":"44","clinical-trial-number":[{"clinical-trial-number":"nct03656536","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7721-1699","authenticated-orcid":false,"given":"Tanios S.","family":"Bekaii-Saab","sequence":"first","affiliation":[{"name":"Mayo Clinic, Phoenix, AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4031-7585","authenticated-orcid":false,"given":"Davide","family":"Melisi","sequence":"additional","affiliation":[{"name":"University of Verona, Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanneke","family":"Wilmink","sequence":"additional","affiliation":[{"name":"Amsterdam UMC, Amsterdam, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Garufi","sequence":"additional","affiliation":[{"name":"Azienda Ospedaliera San Camillo-Forlanini, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6104-6489","authenticated-orcid":false,"given":"Nguyen","family":"Tran","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1378-4962","authenticated-orcid":false,"given":"Giampaolo","family":"Tortora","sequence":"additional","affiliation":[{"name":"Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0103-730X","authenticated-orcid":false,"given":"Filippo","family":"De Braud","sequence":"additional","affiliation":[{"name":"Istituto Nazionale Tumori, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan-Erik","family":"Frodin","sequence":"additional","affiliation":[{"name":"Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7593-8138","authenticated-orcid":false,"given":"Sara","family":"Lonardi","sequence":"additional","affiliation":[{"name":"Veneto Institute of Oncology IOV\u2014IRCCS, Padua, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Lin","sequence":"additional","affiliation":[{"name":"Providence Cancer Institute, Portland, OR"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9368-6296","authenticated-orcid":false,"given":"Hani","family":"Babiker","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Jacksonville, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce","family":"Lin","sequence":"additional","affiliation":[{"name":"Virginia Mason Medical Center, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0187-5904","authenticated-orcid":false,"given":"Lorenzo","family":"Fornaro","sequence":"additional","affiliation":[{"name":"Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6977-8249","authenticated-orcid":false,"given":"Andr\u00e9s","family":"Mu\u00f1oz Mart\u00edn","sequence":"additional","affiliation":[{"name":"Instituto de Investigaci\u00f3n Sanitaria Gregorio Mara\u00f1\u00f3n, Universidad Complutense, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9186-1604","authenticated-orcid":false,"given":"John","family":"Bridgewater","sequence":"additional","affiliation":[{"name":"CL Cancer Institute, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3474-6647","authenticated-orcid":false,"given":"Jennifer J.","family":"Knox","sequence":"additional","affiliation":[{"name":"University Health Network, Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2578-1766","authenticated-orcid":false,"given":"Judith","family":"De Vos-Geelen","sequence":"additional","affiliation":[{"name":"Maastricht University Medical Center, GROW\u2014Research Institute for Oncology &amp; 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