{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T21:01:35Z","timestamp":1791493295474,"version":"4.3.4"},"reference-count":24,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"22","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2024,8,1]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> Taletrectinib, a highly potent, CNS-active, ROS1 tyrosine kinase inhibitor (TKI), has demonstrated high and durable response rates, high intracranial objective response rate (ORR), prolonged progression-free survival (PFS), and activity against G2032R with a favorable safety profile. We report outcomes from the pivotal TRUST-I study (ClinicalTrials.gov identifier: NCT04395677 ) of taletrectinib for ROS1+ non\u2013small cell lung cancer in China. <\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p> TRUST-I evaluated TKI-na\u0457ve and crizotinib-pretreated patients. The primary end point was confirmed ORR (cORR) by independent review committee; key secondary end points included duration of response (DOR), PFS, and safety. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> As of November 2023, 173 patients were enrolled (median age, 55 years; 58% female; 73% never smoked; TKI na\u0457ve: n = 106; crizotinib pretreated: n = 67). In TKI-na\u0457ve patients, cORR and intracranial cORR were 91% and 88%, respectively, and 52% and 73% in crizotinib-pretreated patients. In TKI-na\u0457ve patients, median DOR and median PFS were not reached (NR) with 22.1-month and 23.5-month follow-up, respectively. In crizotinib-pretreated patients, the median DOR was 10.6 months (95% CI, 6.3 months to NR; 8.4-month follow-up), and the median PFS was 7.6 months (95% CI, 5.5 to 12.0 months; 9.7-month follow-up). Eight of 12 patients (67%) with G2032R mutations responded. The most frequent treatment-emergent adverse events (TEAEs) were increased AST (76%), diarrhea (70%), and increased ALT (68%), most of which were grade 1-2. Incidences of neurologic TEAEs were low (dizziness: 23%; dysgeusia: 10%) and mostly grade 1. Discontinuations (5%) and dose reductions (19%) due to TEAEs were low. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> Taletrectinib continues to show high and durable overall responses, prolonged PFS, robust activity against intracranial lesions and acquired resistance mutations including G2032R, and a favorable safety profile with a low incidence of neurologic TEAEs. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.24.00731","type":"journal-article","created":{"date-parts":[[2024,6,1]],"date-time":"2024-06-01T12:00:28Z","timestamp":1717243228000},"page":"2660-2670","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":42,"title":["Efficacy and Safety of Taletrectinib in Chinese Patients With <i>ROS1+<\/i> Non\u2013Small Cell Lung Cancer: The Phase II TRUST-I 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Shandong Cancer Hospital and Institute, Jinan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingxun","family":"Wu","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Xiamen University, Xiamen, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ziping","family":"Wang","sequence":"additional","affiliation":[{"name":"Beijing Cancer Hospital, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunpeng","family":"Liu","sequence":"additional","affiliation":[{"name":"The First Hospital of China Medical University, Shenyang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xicheng","family":"Wang","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital\/School of Clinical Medicine Guangdong Pharmaceutical University, Guangzhou, 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