{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T23:24:23Z","timestamp":1793316263562,"version":"4.5.0"},"reference-count":37,"publisher":"American Medical Association (AMA)","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n \n Brain metastases reduce overall survival rates of patients with non\u2013small cell lung cancer (NSCLC); patients with epidermal growth factor receptor 2 (\n ERBB2<\/jats:italic>\n [formerly\n HER2<\/jats:italic>\n ])\u2013mutant NSCLC are more likely to have baseline brain metastases. Trastuzumab deruxtecan (T-DXd) is an approved\n ERBB2<\/jats:italic>\n -directed treatment for previously treated unresectable or metastatic\n ERBB2-<\/jats:italic>\n mutant NSCLC.\n <\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n \n To assess the clinical effectiveness and safety of T-DXd 5.4 mg\/kg and 6.4 mg\/kg doses in patients with previously treated\n ERBB2-<\/jats:italic>\n mutant metastatic NSCLC with or without untreated or previously treated stable brain metastases.\n <\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n \n This post hoc secondary analysis pooled patients from the DESTINY-Lung01 (data cutoff date: December 3, 2021) and DESTINY-Lung02 (data cutoff date: December 23, 2022) clinical trials by T-DXd dose (5.4 mg\/kg and 6.4 mg\/kg). DESTINY-Lung01 was a multicenter, open-label, 2-cohort, nonrandomized phase 2 study, while DESTINY-Lung02 was a dose-blinded, multicenter, 2-cohort, randomized phase 2 study. Participants had a previously treated\n ERBB2-<\/jats:italic>\n mutant metastatic NSCLC with or without untreated or previously treated stable brain metastases at baseline. All statistical analyses were performed from April 2023 to October 2024.\n <\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Patients received a T-DXd dose of either 5.4 mg\/kg or 6.4 mg\/kg intravenously every 3 weeks.<\/jats:p>\n <\/jats:sec>\n \n Main Outcome and Measure<\/jats:title>\n Systemic and intracranial effectiveness by blinded independent central review using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1, sites of progression, and safety.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n This analysis included 102 patients in the T-DXd 5.4-mg\/kg dose group (65 females [64%]; median [range] age, 57.5 [37.0-83.0] years and 59.5 [30.0-79.0] years in patients with and without brain metastases, respectively) and 141 patients in the T-DXd 6.4-mg\/kg dose group (94 females [67%]; median [range] age, 62.5 [29.0-88.0] years and 59.0 [27.0-83.0] years in patients with and without brain metastases, respectively). In each group, 31% (32 of 102) and 38% (54 of 141) of patients, respectively, had baseline brain metastases and 53% (17 of 32) and 44% (24 of 54), respectively, received prior brain metastasis treatment. In patients with and without brain metastases, systemic confirmed objective response rates (ORRs) were 47% (15 of 32; 95% CI, 29%-65%) and 50% (35 of 70; 95% CI, 38%-62%), respectively, with the T-DXd 5.4-mg\/kg dose, and 50% (27 of 54; 95% CI, 36%-64%) and 59% (51 of 87; 95% CI, 48%-69%) with the T-DXd 6.4-mg\/kg dose. Median progression-free survival was 7.1 (95% CI, 5.5-9.7) months in the T-DXd 5.4-mg\/kg dose group and 7.1 (95% CI, 4.5-9.6) months in the T-DXd 6.4-mg\/kg dose group of patients with baseline brain metastases. Among patients with measurable baseline brain metastases, intracranial confirmed ORRs were 50% (7 of 14; 95% CI, 23%-77%) with the T-DXd 5.4-mg\/kg dose and 30% (9 of 30; 95% CI, 15%-49%) with the T-DXd 6.4-mg\/kg dose. At both doses, the safety profile of T-DXd was generally manageable, regardless of baseline brain metastases, favoring the T-DXd 5.4 mg\/kg dose.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n \n In this secondary analysis, T-DXd at the approved dose of 5.4 mg\/kg showed antitumor activity in patients with previously treated\n ERBB2-<\/jats:italic>\n mutant metastatic NSCLC with or without brain metastases. This finding supports T-DXd 5.4 mg\/kg use in this population.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2025.43107","type":"journal-article","created":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T13:00:16Z","timestamp":1764680416000},"page":"e2543107","source":"Crossref","is-referenced-by-count":27,"title":["Trastuzumab Deruxtecan for\n ERBB2<\/i>\n -Mutant Metastatic Non\u2013Small Cell Lung Cancer With or Without Brain Metastases"],"prefix":"10.1001","volume":"8","author":[{"given":"Pasi A.","family":"J\u00e4nne","sequence":"first","affiliation":[{"name":"Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Planchard","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Thoracic Cancer Group, Gustave Roussy, Medical Oncology, Villejuif, 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