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Long-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials
DC Field | Value | Language |
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dc.contributor.author | Gettinger, Scott N. | - |
dc.contributor.author | Huber, Rudolf M. | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Bazhenova, Lyudmila | - |
dc.contributor.author | Hansen, Karin Holmskov | - |
dc.contributor.author | Tiseo, Marcello | - |
dc.contributor.author | Langer, Corey J. | - |
dc.contributor.author | Paz-Ares Rodríguez, Luis G. | - |
dc.contributor.author | West, Howard L. | - |
dc.contributor.author | Reckamp, Karen L. | - |
dc.contributor.author | Weiss, Glen J. | - |
dc.contributor.author | Smit, Egbert F. | - |
dc.contributor.author | Hochmair, Maximilian J. | - |
dc.contributor.author | Kim, Sang-We | - |
dc.contributor.author | Ahn, Myung-Ju | - |
dc.contributor.author | Kim, Edward S. | - |
dc.contributor.author | Groen, Harry J.M. | - |
dc.contributor.author | Pye, Joanna | - |
dc.contributor.author | Liu, Yuyin | - |
dc.contributor.author | Zhang, Pingkuan | - |
dc.contributor.author | Vranceanu, Florin | - |
dc.contributor.author | Camidge, D. Ross | - |
dc.date.accessioned | 2023-05-26T01:17:24Z | - |
dc.date.available | 2023-05-26T01:17:24Z | - |
dc.date.created | 2023-05-25 | - |
dc.date.created | 2023-05-25 | - |
dc.date.created | 2023-05-25 | - |
dc.date.created | 2023-05-25 | - |
dc.date.created | 2023-05-25 | - |
dc.date.created | 2023-05-25 | - |
dc.date.created | 2023-05-25 | - |
dc.date.created | 2023-05-25 | - |
dc.date.issued | 2022-09 | - |
dc.identifier.citation | JTO Clinical and Research Reports, Vol.3 No.9, p. 100385 | - |
dc.identifier.issn | 2666-3643 | - |
dc.identifier.uri | https://hdl.handle.net/10371/192475 | - |
dc.description.abstract | © 2022 The AuthorsIntroduction: We report brigatinib long-term efficacy and safety from phase 1/2 and phase 2 (ALTA) trials in ALK–rearrangement positive (ALK+) NSCLC. Methods: The phase 1/2 study evaluated brigatinib 30 to 300 mg/d in patients with advanced malignancies. ALTA randomized patients with crizotinib-refractory ALK+ NSCLC to brigatinib 90 mg once daily (arm A) or 180 mg once daily (7-d lead-in at 90 mg; arm B). Results: In the phase 1/2 study, 79 of 137 brigatinib-treated patients had ALK+ NSCLC; 71 were crizotinib pretreated. ALTA randomized 222 patients (n = 112 in arm A; n = 110 in arm B). Median follow-up at phase 1/2 study end (≈5.6 y after last patient enrolled) was 27.7 months; at ALTA study end (≈4.4 y after last patient enrolled), 19.6 months (A) and 28.3 months (B). Among patients with ALK+ NSCLC in the phase 1/2 study, median investigator-assessed progression-free survival (PFS) was 14.5 months (95% confidence interval [CI]: 10.8–21.2); median overall survival was 47.6 months (28.6–not reached). In ALTA, median investigator-assessed PFS was 9.2 months (7.4–11.1) in arm A and 15.6 months (11.1–18.5) in arm B; median independent review committee (IRC)-assessed PFS was 9.9 (7.4–12.8) and 16.7 (11.6–21.4) months, respectively; median overall survival was 25.9 (18.2–45.8) and 40.6 (32.5–not reached) months, respectively. Median intracranial PFS for patients with any brain metastases was 12.8 (9.2–18.4) months in arm A and 18.4 (12.6–23.9) months in arm B. No new safety signals were identified versus previous analyses. Conclusions: Brigatinib exhibited sustained long-term activity and PFS with manageable safety in patients with crizotinib-refractory ALK+ NSCLC. | - |
dc.language | 영어 | - |
dc.publisher | Elsevier | - |
dc.title | Long-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.jtocrr.2022.100385 | - |
dc.citation.journaltitle | JTO Clinical and Research Reports | - |
dc.identifier.wosid | 001137483200007 | - |
dc.identifier.scopusid | 2-s2.0-85136559895 | - |
dc.citation.number | 9 | - |
dc.citation.startpage | 100385 | - |
dc.citation.volume | 3 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | CELL LUNG-CANCER | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | KINASE INHIBITOR | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | ALECTINIB | - |
dc.subject.keywordPlus | CERITINIB | - |
dc.subject.keywordPlus | METASTASES | - |
dc.subject.keywordPlus | OUTCOMES | - |
dc.subject.keywordPlus | AP26113 | - |
dc.subject.keywordPlus | POTENT | - |
dc.subject.keywordAuthor | ALK tyrosine kinase inhibitor | - |
dc.subject.keywordAuthor | Anaplastic lymphoma kinase | - |
dc.subject.keywordAuthor | Brigatinib | - |
dc.subject.keywordAuthor | Crizotinib | - |
dc.subject.keywordAuthor | Non–small-cell lung cancer | - |
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