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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

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dc.contributor.authorViola W. Zhuen_US
dc.contributor.authorYen Ting Linen_US
dc.contributor.authorDong Wan Kimen_US
dc.contributor.authorHerbert H. Loongen_US
dc.contributor.authorMisako Nagasakaen_US
dc.contributor.authorHao Toen_US
dc.contributor.authorYvonne Li En Angen_US
dc.contributor.authorChan Young Ocken_US
dc.contributor.authorNishan Tchekmedyianen_US
dc.contributor.authorSai Hong Ignatius Ouen_US
dc.contributor.authorNicholas L. Synen_US
dc.contributor.authorThanyanan Reungwetwattanaen_US
dc.contributor.authorChia Chi Linen_US
dc.contributor.authorRoss A. Sooen_US
dc.contributor.otherNational Taiwan University Hospitalen_US
dc.contributor.otherYong Loo Lin School of Medicineen_US
dc.contributor.otherNational Taiwan University College of Medicineen_US
dc.contributor.otherSeoul National University Hospitalen_US
dc.contributor.otherWayne State University School of Medicineen_US
dc.contributor.otherNational University of Singaporeen_US
dc.contributor.otherFaculty of Medicine, Ramathibodi Hospital, Mahidol Universityen_US
dc.contributor.otherUCI School of Medicineen_US
dc.contributor.otherUniversity of Nevada School of Medicineen_US
dc.contributor.otherChinese University of Hong Kongen_US
dc.contributor.otherPacific Shores Medical Groupen_US
dc.date.accessioned2020-08-25T11:29:08Z
dc.date.available2020-08-25T11:29:08Z
dc.date.issued2020-01-01en_US
dc.description.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.en_US
dc.identifier.citationJournal of Thoracic Oncology. (2020)en_US
dc.identifier.doi10.1016/j.jtho.2020.04.019en_US
dc.identifier.issn15561380en_US
dc.identifier.issn15560864en_US
dc.identifier.other2-s2.0-85086020844en_US
dc.identifier.urihttps://hdl.handle.net/20.500.14594/58338
dc.rightsMahidol Universityen_US
dc.rights.holderSCOPUSen_US
dc.source.urihttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85086020844&origin=inwarden_US
dc.subjectMedicineen_US
dc.titleAn 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 NSCLCen_US
dc.typeArticleen_US
dspace.entity.typePublication
mu.datasource.scopushttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85086020844&origin=inwarden_US
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