Afshin Dowlati, Anne C Chiang, Andrés Cervantes, Sunil Babu, Erika Hamilton, Shu Fen Wong, Andrea Tazbirkova, Ivana Gabriela Sullivan, Cédric van Marcke, Antoine Italiano, Jilpa Patel, Sabeen Mekan, Tia Wu, Saiama N Waqar
{"title":"Sacituzumab Govitecan作为广泛期小细胞肺癌患者的二线治疗的2期开放标签研究：来自tropic -03的结果","authors":"Afshin Dowlati, Anne C Chiang, Andrés Cervantes, Sunil Babu, Erika Hamilton, Shu Fen Wong, Andrea Tazbirkova, Ivana Gabriela Sullivan, Cédric van Marcke, Antoine Italiano, Jilpa Patel, Sabeen Mekan, Tia Wu, Saiama N Waqar","doi":"10.1016/j.jtho.2024.12.028","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The phase 2 TROPiCS-03 study evaluated the efficacy/safety of sacituzumab govitecan (SG) as second-line treatment in patients with previously treated extensive-stage SCLC (ES-SCLC).</p><p><strong>Methods: </strong>TROPiCS-03 (NCT03964727) is a multicohort, open-label, phase 2 basket study of solid tumors, including ES-SCLC. Adults with ES-SCLC that progressed after one previous line of platinum-based chemotherapy and anti-programmed death-(ligand) 1 (PD-[L]1) therapy received SG 10 mg/kg on days 1 and 8 of a 21-day cycle. The primary end point was the investigator-assessed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1. Key secondary end points included investigator-assessed duration of response (DOR) and progression-free survival (PFS); blinded independent central review-assessed ORR, DOR, and PFS; overall survival (OS); and safety. Efficacy was evaluated in patients with platinum-resistant and platinum-sensitive disease.</p><p><strong>Results: </strong>Among 43 patients (median follow-up, 12.3 [range, 8.1-20.1] mo), investigator-assessed ORR was 41.9% (95% confidence interval [CI]: 27.0%-57.9%), with 18 confirmed partial responses; median (95% CI) DOR, PFS, and OS were 4.73 (3.52-6.70), 4.40 (3.81-6.11), and 13.60 (6.57-14.78) months, respectively. The efficacy results of the blinded independent central review assessments were similar. The investigator-assessed ORR (95% CI) was 35.0% (15.4%-59.2%) in patients with platinum-resistant disease (n = 20) and 47.8% (26.8%-69.4%) in patients with platinum-sensitive disease (n = 23). Furthermore, 32 patients (74.4%) had grade greater than or equal to 3 treatment-emergent adverse events (TEAEs). No TEAE led to SG discontinuation; one treatment-related TEAE (neutropenic sepsis) led to death.</p><p><strong>Conclusions: </strong>SG has promising efficacy as second-line treatment of ES-SCLC, irrespective of platinum sensitivity. Safety was manageable and consistent with that observed in other SG studies.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0000,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03.\",\"authors\":\"Afshin Dowlati, Anne C Chiang, Andrés Cervantes, Sunil Babu, Erika Hamilton, Shu Fen Wong, Andrea Tazbirkova, Ivana Gabriela Sullivan, Cédric van Marcke, Antoine Italiano, Jilpa Patel, Sabeen Mekan, Tia Wu, Saiama N Waqar\",\"doi\":\"10.1016/j.jtho.2024.12.028\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The phase 2 TROPiCS-03 study evaluated the efficacy/safety of sacituzumab govitecan (SG) as second-line treatment in patients with previously treated extensive-stage SCLC (ES-SCLC).</p><p><strong>Methods: </strong>TROPiCS-03 (NCT03964727) is a multicohort, open-label, phase 2 basket study of solid tumors, including ES-SCLC. Adults with ES-SCLC that progressed after one previous line of platinum-based chemotherapy and anti-programmed death-(ligand) 1 (PD-[L]1) therapy received SG 10 mg/kg on days 1 and 8 of a 21-day cycle. The primary end point was the investigator-assessed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1. Key secondary end points included investigator-assessed duration of response (DOR) and progression-free survival (PFS); blinded independent central review-assessed ORR, DOR, and PFS; overall survival (OS); and safety. Efficacy was evaluated in patients with platinum-resistant and platinum-sensitive disease.</p><p><strong>Results: </strong>Among 43 patients (median follow-up, 12.3 [range, 8.1-20.1] mo), investigator-assessed ORR was 41.9% (95% confidence interval [CI]: 27.0%-57.9%), with 18 confirmed partial responses; median (95% CI) DOR, PFS, and OS were 4.73 (3.52-6.70), 4.40 (3.81-6.11), and 13.60 (6.57-14.78) months, respectively. The efficacy results of the blinded independent central review assessments were similar. The investigator-assessed ORR (95% CI) was 35.0% (15.4%-59.2%) in patients with platinum-resistant disease (n = 20) and 47.8% (26.8%-69.4%) in patients with platinum-sensitive disease (n = 23). Furthermore, 32 patients (74.4%) had grade greater than or equal to 3 treatment-emergent adverse events (TEAEs). No TEAE led to SG discontinuation; one treatment-related TEAE (neutropenic sepsis) led to death.</p><p><strong>Conclusions: </strong>SG has promising efficacy as second-line treatment of ES-SCLC, irrespective of platinum sensitivity. Safety was manageable and consistent with that observed in other SG studies.</p>\",\"PeriodicalId\":17515,\"journal\":{\"name\":\"Journal of Thoracic Oncology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":21.0000,\"publicationDate\":\"2025-01-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Thoracic Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jtho.2024.12.028\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Thoracic Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jtho.2024.12.028","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03.
Introduction: The phase 2 TROPiCS-03 study evaluated the efficacy/safety of sacituzumab govitecan (SG) as second-line treatment in patients with previously treated extensive-stage SCLC (ES-SCLC).
Methods: TROPiCS-03 (NCT03964727) is a multicohort, open-label, phase 2 basket study of solid tumors, including ES-SCLC. Adults with ES-SCLC that progressed after one previous line of platinum-based chemotherapy and anti-programmed death-(ligand) 1 (PD-[L]1) therapy received SG 10 mg/kg on days 1 and 8 of a 21-day cycle. The primary end point was the investigator-assessed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1. Key secondary end points included investigator-assessed duration of response (DOR) and progression-free survival (PFS); blinded independent central review-assessed ORR, DOR, and PFS; overall survival (OS); and safety. Efficacy was evaluated in patients with platinum-resistant and platinum-sensitive disease.
Results: Among 43 patients (median follow-up, 12.3 [range, 8.1-20.1] mo), investigator-assessed ORR was 41.9% (95% confidence interval [CI]: 27.0%-57.9%), with 18 confirmed partial responses; median (95% CI) DOR, PFS, and OS were 4.73 (3.52-6.70), 4.40 (3.81-6.11), and 13.60 (6.57-14.78) months, respectively. The efficacy results of the blinded independent central review assessments were similar. The investigator-assessed ORR (95% CI) was 35.0% (15.4%-59.2%) in patients with platinum-resistant disease (n = 20) and 47.8% (26.8%-69.4%) in patients with platinum-sensitive disease (n = 23). Furthermore, 32 patients (74.4%) had grade greater than or equal to 3 treatment-emergent adverse events (TEAEs). No TEAE led to SG discontinuation; one treatment-related TEAE (neutropenic sepsis) led to death.
Conclusions: SG has promising efficacy as second-line treatment of ES-SCLC, irrespective of platinum sensitivity. Safety was manageable and consistent with that observed in other SG studies.
期刊介绍：
Journal of Thoracic Oncology (JTO), the official journal of the International Association for the Study of Lung Cancer,is the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies.The readship includes epidemiologists, medical oncologists, radiation oncologists, thoracic surgeons, pulmonologists, radiologists, pathologists, nuclear medicine physicians, and research scientists with a special interest in thoracic oncology.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
