{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:34:24Z","timestamp":1790814864447,"version":"4.1.0"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2024,4,17]],"date-time":"2024-04-17T00:00:00Z","timestamp":1713312000000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009930","name":"Basilea Pharmaceutica","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009930","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100009930","name":"Basilea Pharmaceutica","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009930","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,4,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>This Phase 1b\/2 study assessed the efficacy in terms of objective response rate (ORR) of the FGFR1\/2\/3 kinase inhibitor derazantinib as monotherapy or in combination with atezolizumab in patients with metastatic urothelial cancer (mUC) and FGFR1-3 genetic aberrations (FGFR1-3GA).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This multicenter, open-label study comprised 5 substudies. In Substudies 1 and 5, patients with mUC with FGFR1\u20133GA received derazantinib monotherapy (300\u2009mg QD in Substudy 1, 200\u2009mg BID in Substudy 5). In Substudy 2, patients with any solid tumor received atezolizumab 1200\u2009mg every 3\u2009weeks plus derazantinib 200 or 300\u2009mg QD. In Substudy 3, patients with mUC harboring FGFR1\u20133GA received derazantinib 200\u2009mg BID plus atezolizumab 1200\u2009mg every 3\u2009weeks. In Substudy 4, patients with FGFR inhibitor-resistant mUC harboring FGFR1\u20133GA received derazantinib 300\u2009mg QD monotherapy or derazantinib 300\u2009mg QD plus atezolizumab 1200\u2009mg every 3\u2009weeks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The ORR for Substudies 1 and 5 combined was 4\/49 (8.2%, 95% confidence interval = 2.3% to 19.6%), which was based on 4 partial responses. The ORR in Substudy 4 was 1\/7 (14.3%, 95% confidence interval = 0.4% to 57.9%; 1 partial response for derazantinib 300\u2009mg monotherapy, zero for derazantinib 300\u2009mg plus atezolizumab 1200\u2009mg). In Substudy 2, derazantinib 300\u2009mg plus atezolizumab 1200\u2009mg was identified as a recommended dose for Phase 2. Only 2 patients entered Substudy 3.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Derazantinib as monotherapy or in combination with atezolizumab was well-tolerated but did not show sufficient efficacy to warrant further development in mUC.<\/jats:p>\n                  <jats:p>Clinicaltrials.gov NCT04045613, EudraCT 2019-000359-15<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jncics\/pkae030","type":"journal-article","created":{"date-parts":[[2024,4,17]],"date-time":"2024-04-17T02:51:22Z","timestamp":1713322282000},"source":"Crossref","is-referenced-by-count":11,"title":["Derazantinib alone and with atezolizumab in metastatic urothelial carcinoma with activating FGFR 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