Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/30327
Title: Long-Term Efficacy and Safety of Entrectinib in ROS1 Fusion-Positive NSCLC.
Austin Authors: Drilon, Alexander;Chiu, Chao-Hua;Fan, Yun;Cho, Byoung Chul;Lu, Shun;Ahn, Myung-Ju;Krebs, Matthew G;Liu, Stephen V;John, Thomas ;Otterson, Gregory A;Tan, Daniel S W;Patil, Tejas;Dziadziuszko, Rafal;Massarelli, Erminia;Seto, Takashi;Doebele, Robert C;Pitcher, Bethany;Kurtsikidze, Nino;Heinzmann, Sebastian;Siena, Salvatore
Affiliation: Olivia Newton-John Cancer Wellness and Research Centre
Department of Medicine, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medical College, New York, New York..
Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan..
Zhejiang Cancer Hospital, Hangzhou, People's Republic of China..
Division of Medical Oncology, Yonsei Cancer Center, Seoul, Republic of Korea..
Department of Medical Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, People's Republic of China..
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Republic of Korea..
Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester and The Christie National Health Service (NHS) Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom..
Georgetown University, Washington, District of Columbia..
Arthur G. James Cancer Hospital, and Richard J. Solove Research Institute, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio..
Division of Medical Oncology, National Cancer Centre Singapore, Duke-National University of Singapore (NUS) Medical School, Singapore..
Division of Medical Oncology, Department of Medicine, University of Colorado, Aurora, Colorado..
Department of Oncology and Radiotherapy and Early Clinical Trials Center, Medical University of Gdansk, Gdansk, Poland..
Department of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, California..
Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan..
F. Hoffmann-La Roche Ltd, Mississauga, Canada..
F. Hoffmann-La Roche Ltd, Basel, Switzerland..
Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy..
Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, Milan, Italy..
Department of Medical Oncology, Peter MacCallum Cancer Center, Melbourne, Australia..
Issue Date: 29-Apr-2022
Date: 2022-06
Publication information: JTO clinical and research reports 2022; 3(6): 100332
Abstract: Entrectinib is an approved tyrosine kinase inhibitor (TKI) for ROS1 fusion-positive NSCLC. An updated integrated analysis of entrectinib from the ALKA-372-001, STARTRK-1, and STARTRK-2 trials is presented, with substantially longer follow-up, more patients, and the first description of the median overall survival (OS). An exploratory analysis of entrectinib in ROS1 fusion-positive NSCLC with the central nervous system (CNS)-only progression post-crizotinib is reported. Adults with ROS1 fusion-positive, locally advanced or metastatic NSCLC who received at least one dose of entrectinib and had 12 months or longer of follow-up were included in the analysis. Co-primary end points were confirmed objective response rate (ORR) and duration of response (DoR) by blinded independent central review. The data cutoff was on August 31, 2020. The efficacy-assessable population comprised 168 ROS1 TKI-naïve patients. The median survival follow-up was 29.1 months (interquartile range, 21.8-35.9). The ORR was 68% (95% confidence interval [CI]: 60.2-74.8); the median DoR was 20.5 months. The median progression-free survival (PFS) was 15.7 months and the median OS was 47.8 months. In the 25 patients with measurable baseline CNS metastases, the intracranial ORR was 80% (95% CI: 59.3-93.2), median intracranial DoR was 12.9 months, and median intracranial PFS was 8.8 months. Among 18 patients with CNS-only progression on previous crizotinib treatment, two achieved a partial response (11%) and four had stable disease (22%). In seven patients with measurable CNS disease from this cohort, the intracranial ORR was 14% (1 partial response). Entrectinib is active and achieves prolonged survival in ROS1 TKI-naïve patients with ROS1 fusion-positive NSCLC. Modest activity is seen in patients with CNS-only progression post-crizotinib.
URI: https://ahro.austin.org.au/austinjspui/handle/1/30327
DOI: 10.1016/j.jtocrr.2022.100332
ORCID: 0000-0003-3399-5342
Journal: JTO clinical and research reports
PubMed URL: 35663414
PubMed URL: https://pubmed.ncbi.nlm.nih.gov/35663414/
Type: Journal Article
Subjects: Entrectinib
Intracranial efficacy
NSCLC
ROS1 fusions
Treatment post-crizotinib
Appears in Collections:Journal articles

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