{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T20:08:20Z","timestamp":1792267700403,"version":"4.4.0"},"reference-count":24,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"13","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,5,1]]},"abstract":"<jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      <jats:italic toggle=\"yes\">RET<\/jats:italic>\n                      fusions appear in 1%-2% of non\u2013small cell lung cancers (NSCLCs). The results from the ARROW study (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\/NCT03037385\">NCT03037385<\/jats:ext-link>\n                      ) supported US Food and Drug Administration approval of pralsetinib, an oral selective RET inhibitor, for metastatic\n                      <jats:italic toggle=\"yes\">RET<\/jats:italic>\n                      -altered NSCLC and\n                      <jats:italic toggle=\"yes\">RET<\/jats:italic>\n                      fusion\u2013positive thyroid cancers. ARROW was a phase I\/II open-label study of pralsetinib 400 mg once daily in\n                      <jats:italic toggle=\"yes\">RET<\/jats:italic>\n                      fusion\u2013positive NSCLCs. Coprimary end points were overall response rate (ORR) and safety. Key secondary end points included duration of response, progression-free survival, and overall survival (OS). At data lock (May 20, 2024), 281 patients initiated pralsetinib (median treatment duration, 15.0 months). ORR (measurable disease patients; n = 259) was 78% (95% CI, 69 to 86) for treatment-na\u00efve patients and 63% (95% CI, 54 to 71) for prior platinum-based chemotherapy patients. Median OS was 44.3 months (95% CI, 30.9 to 53.1), 50.1 months (95% CI, 28.3 to not reached) in treatment-na\u00efve patients, and 39.7 months (95% CI, 27.8 to 53.2) in prior platinum patients. Common grade \u22653 treatment-related adverse events were anemia (21%), hypertension (15%), and decreased neutrophils (13%). Three treatment-related deaths occurred (pneumonia, n = 2; interstitial lung disease and rhabdomyolysis, n = 1 each). Safety was consistent with previous ARROW reports; no hypersensitivity was reported in patients receiving prior immunotherapies. Pralsetinib produced robust, durable responses with manageable safety in treatment-na\u00efve and previously treated patients with\n                      <jats:italic toggle=\"yes\">RET<\/jats:italic>\n                      fusion\u2013positive NSCLCs, confirming previous findings with longer follow-up.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-01489","type":"journal-article","created":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T20:00:10Z","timestamp":1774555210000},"page":"1190-1197","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":4,"title":["Final Efficacy and Safety Data From the Phase I\/II ARROW Study of Pralsetinib in Patients With Advanced\n                    <i>RET<\/i>\n                    Fusion\u2013Positive Non\u2013Small Cell Lung Cancer"],"prefix":"10.1200","volume":"44","clinical-trial-number":[{"clinical-trial-number":"nct03037385","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5090-8189","authenticated-orcid":true,"given":"Benjamin","family":"Besse","sequence":"first","affiliation":[{"name":"Department of Cancer Medicine, Gustave Roussy Cancer Campus, Paris Saclay University, Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6064-6837","authenticated-orcid":true,"given":"Vivek","family":"Subbiah","sequence":"additional","affiliation":[{"name":"UT MD Anderson Cancer Center, Houston, TX"},{"name":"Sarah Cannon Research Institute, Nashville, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1781-2518","authenticated-orcid":true,"given":"Giuseppe","family":"Curigliano","sequence":"additional","affiliation":[{"name":"Istituto Europeo di Oncologia, IRCCS, Milano, Italy"},{"name":"Department of Oncology and Hemato-Oncology, University of Milano, Milano, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1406-0963","authenticated-orcid":true,"given":"Daniel W.","family":"Bowles","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Medicine, University of Colorado Cancer Center, Aurora, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert C.","family":"Doebele","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Medicine, University of Colorado Cancer Center, Aurora, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9483-6903","authenticated-orcid":true,"given":"Aaron S.","family":"Mansfield","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Oncology, Mayo Clinic, Rochester, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina S.","family":"Baik","sequence":"additional","affiliation":[{"name":"Division of Medical Hematology and Oncology, Department of Medicine, University of Washington, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1151-9903","authenticated-orcid":true,"given":"Gilberto","family":"de Lima Lopes","sequence":"additional","affiliation":[{"name":"Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1947-3364","authenticated-orcid":true,"given":"Luis","family":"Paz-Ares","sequence":"additional","affiliation":[{"name":"Hospital Universitario 12 de Octubre, CNIO-H12O Lung Cancer Unit, Complutense University &amp; Ciberonc, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2409-9001","authenticated-orcid":true,"given":"Matthew H.","family":"Taylor","sequence":"additional","affiliation":[{"name":"Earle A. 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