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Brigatinib Versus Alectinib in ALK-Positive NSCLC After Disease Progression on Crizotinib: Results of Phase 3 ALTA-3 Trial
DC Field | Value | Language |
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dc.contributor.author | Yang, James Chih-Hsin | - |
dc.contributor.author | Liu, Geoffrey | - |
dc.contributor.author | Lu, Shun | - |
dc.contributor.author | He, Jianxing | - |
dc.contributor.author | Burotto, Mauricio | - |
dc.contributor.author | Ahn, Myung-Ju | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Liu, XiaoQing | - |
dc.contributor.author | Zhao, Yanqiu | - |
dc.contributor.author | Vincent, Sylvie | - |
dc.contributor.author | Yin, Jiani | - |
dc.contributor.author | Ma, Xin | - |
dc.contributor.author | Lin, Huamao M. | - |
dc.contributor.author | Popat, Sanjay | - |
dc.date.accessioned | 2024-01-04T08:00:51Z | - |
dc.date.available | 2024-01-04T08:00:51Z | - |
dc.date.created | 2023-12-19 | - |
dc.date.created | 2023-12-19 | - |
dc.date.issued | 2023-12 | - |
dc.identifier.citation | Journal of Thoracic Oncology, Vol.18 No.12, pp.1743-1755 | - |
dc.identifier.issn | 1556-0864 | - |
dc.identifier.uri | https://hdl.handle.net/10371/198785 | - |
dc.description.abstract | Introduction: This open-label, phase 3 trial (ALTA-3; NCT03596866) compared efficacy and safety of brigatinib versus alectinib for ALK+ NSCLC after disease progression on crizotinib. Methods: Patients with advanced ALK+ NSCLC that progressed on crizotinib were randomized 1:1 to brigatinib 180 mg once daily (7-d lead-in, 90 mg) or alectinib 600 mg twice daily, aiming to test superiority. The primary end point was blinded independent review committee–assessed progression-free survival (PFS). Interim analysis for efficacy and futility was planned at approximately 70% of 164 expected PFS events. Results: The population (N = 248; brigatinib, n = 125; alectinib, n = 123) was notable for long median duration of prior crizotinib (16.0–16.8 mo) and low rate of ALK fusion in baseline circulating tumor DNA (ctDNA; 78 of 232 [34%]). Median blinded independent review committee–assessed PFS was 19.3 months with brigatinib and 19.2 months with alectinib (hazard ratio = 0.97 [95% confidence interval: 0.66–1.42], p = 0.8672]). The study met futility criterion. Overall survival was immature (41 events [17%]). Exploratory analyses pooled across the treatment groups revealed median PFS of 11.1 versus 22.5 months in patients with versus without ctDNA-detectable ALK fusion at baseline (hazard ratio: 0.48 [95% confidence interval: 0.32–0.71]). Treatment-related adverse events in more than 30% of patients (brigatinib, alectinib) were elevated levels of blood creatine phosphokinase (70%, 29%), aspartate aminotransferase (53%, 38%), and alanine aminotransferase (40%, 36%). Conclusions: Brigatinib was not superior to alectinib for PFS in crizotinib-pretreated ALK+ NSCLC. Safety was consistent with the well-established and unique profiles of each drug. The low proportion of patients with ctDNA-detectable ALK fusion may account for prolonged PFS with both drugs in ALTA-3. | - |
dc.language | 영어 | - |
dc.publisher | Elsevier Inc. | - |
dc.title | Brigatinib Versus Alectinib in ALK-Positive NSCLC After Disease Progression on Crizotinib: Results of Phase 3 ALTA-3 Trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/j.jtho.2023.08.010 | - |
dc.citation.journaltitle | Journal of Thoracic Oncology | - |
dc.identifier.wosid | 001129648900001 | - |
dc.identifier.scopusid | 2-s2.0-85171148033 | - |
dc.citation.endpage | 1755 | - |
dc.citation.number | 12 | - |
dc.citation.startpage | 1743 | - |
dc.citation.volume | 18 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | ANAPLASTIC LYMPHOMA KINASE | - |
dc.subject.keywordPlus | CELL LUNG-CANCER | - |
dc.subject.keywordPlus | INHIBITOR | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | MUTATIONS | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | OUTCOMES | - |
dc.subject.keywordPlus | QLQ-C30 | - |
dc.subject.keywordAuthor | Alectinib | - |
dc.subject.keywordAuthor | Anaplastic lymphoma kinase | - |
dc.subject.keywordAuthor | Brigatinib | - |
dc.subject.keywordAuthor | Non–small cell lung cancer | - |
dc.subject.keywordAuthor | Tyrosine kinase inhibitor | - |
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