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Title: An International Real-World Analysis of the Efficacy and Safety of Lorlatinib Through Early or Expanded Access Programs in Patients With Tyrosine Kinase Inhibitor–Refractory ALK-Positive or ROS1-Positive NSCLC
Authors: Viola W. Zhu
Yen Ting Lin
Dong Wan Kim
Herbert H. Loong
Misako Nagasaka
Hao To
Yvonne Li En Ang
Chan Young Ock
Nishan Tchekmedyian
Sai Hong Ignatius Ou
Nicholas L. Syn
Thanyanan Reungwetwattana
Chia Chi Lin
Ross A. Soo
National Taiwan University Hospital
Yong Loo Lin School of Medicine
National Taiwan University College of Medicine
Seoul National University Hospital
Wayne State University School of Medicine
National University of Singapore
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
UCI School of Medicine
University of Nevada School of Medicine
Chinese University of Hong Kong
Pacific Shores Medical Group
Keywords: Medicine
Issue Date: 1-Jan-2020
Citation: Journal of Thoracic Oncology. (2020)
Abstract: © 2020 International Association for the Study of Lung Cancer Introduction: Lorlatinib, a next-generation central nervous system–penetrant ALK/ROS1 tyrosine kinase inhibitor (TKI), is approved to treat TKI-refractory ALK-positive (ALK+) NSCLC based on results from a phase 2 study. Methods: A real-world analysis was performed on ALK+ or ROS1-positive (ROS1+) patients with NSCLC enrolled in lorlatinib early or expanded access programs in Hong Kong, Singapore, South Korea, Taiwan, Thailand, and the United States. Results: A total of 95 patients with NSCLC (76 ALK+ and 19 ROS1+) were analyzed. Among ALK+ patients treated with less than two previous TKIs, two or more previous TKIs, and three or more previous TKIs, the objective response rates (ORR) and median progression-free survival (mPFS) were 42% (95% confidence interval [CI]: 26–59; n = 38) and not reached (NR) (95% CI: 4.5–NR; n = 45), 35% (95% CI: 22–49; n = 55) and 11.2 months (95% CI: 4.5–NR; n = 66), and 18% (95% CI: 4–43; n = 17) and 6.5 months (95% CI: 3.5–11.6; n = 21), respectively. The ORRs and mPFSs were 13% (95% CI: 0–53; n = 8) and 9.2 months (95% CI: 3.3–NR; n = 9) for patients treated with one second-generation ALK TKI as the only ALK TKI received. For ROS1+ patients, ORRs and mPFSs were 41% (95% CI: 18–67; n = 17) and 11.9 months (95% CI: 6.4–NR; n = 19). The intracranial ORRs were 35% (95% CI: 22–49) and 55% (95% CI: 23–83) for 52 ALK+ and 11 ROS1+ patients. mPFS was 9.3 months (95% CI: 1.0–NR; n = 13) for patients with leptomeningeal carcinomatosis. No new safety signals were noted. Conclusion: Lorlatinib exhibited meaningful activity in TKI-refractory ALK+ or ROS1+ patients with NSCLC enrolled in early or expanded access programs.
ISSN: 15561380
Appears in Collections:Scopus 2020

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