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dc.contributor.authorPopat, S.
dc.contributor.authorKim, H. R.
dc.contributor.authorAhn, M. J.
dc.contributor.authorYang, J. C. H.
dc.contributor.authorHan, J. Y.
dc.contributor.authorHochmair, M. J.
dc.contributor.authorLee, K. H.
dc.contributor.authorDelmonte, A.
dc.contributor.authorCampelo, M. R. G.
dc.contributor.authorKim, D. W.
dc.contributor.authorGriesinger, F.
dc.contributor.authorFelip, E.
dc.contributor.authorCalifano, Raffaele
dc.contributor.authorSpira, A.
dc.contributor.authorGettinger, S.
dc.contributor.authorTiseo, M.
dc.contributor.authorNi, Q.
dc.contributor.authorZhang, P.
dc.contributor.authorCamidge, D. R.
dc.date.accessioned2020-12-08T05:36:27Z
dc.date.available2020-12-08T05:36:27Z
dc.date.issued2020en
dc.identifier.citationPopat S, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, et al. 1300P Intracranial efficacy of brigatinib (BRG) vs crizotinib (CRZ): Updated results from the ALTA-1L trial. Annals of Oncology. 2020;31:S840-S1.en
dc.identifier.doi10.1016/j.annonc.2020.08.1614en
dc.identifier.urihttp://hdl.handle.net/10541/623464
dc.description.abstractBackground: BRG, a next-generation ALK tyrosine kinase inhibitor (TKI), has robust overall and intracranial efficacy in CRZ-resistant ALK+ NSCLC. At first ALTA-1L interim analysis (IA) in patients (pts) with TKI-naive ALK+ NSCLC, the primary endpoint, blinded independent review committee (BIRC)-assessed PFS, was met (HR, 0.49; P<0.001; NCT02737501). Similarly, intracranial PFS (iPFS) in the ITT population was significantly improved with BRG vs CRZ (HR, 0.42; P¼0.0006). Here we report updated intracranial efficacy from the second IA. Methods: This open-label, multicenter study enrolled pts with TKI-naive stage IIIB/IV ALK+ NSCLC. Pts were stratified by presence of baseline (BL) brain metastases and history of chemotherapy for advanced disease and randomized 1:1 to BRG 180 mg qd with 7-day lead-in at 90 mg or CRZ 250 mg bid. Primary endpoint was BIRC-assessed PFS (RECIST v1.1). Secondary endpoints included intracranial ORR (iORR) and iPFS. The second IA was planned at w75% of 198 expected PFS events. Results: Of 275 randomized pts (BRG/CRZ, n¼137/138), 34%/36% had BL brain metastases (BIRC-assessed). 13%/14% had prior brain radiotherapy, with whole brain radiation and stereotactic radiosurgery balanced across arms. At data cutoff (28 June 2019; median follow-up [BRG/CRZ], 24.9/15.2 mo, 150 events), iPFS in the ITT population remained significantly improved with BRG (HR, 0.45 [95% CI, 0.29e0.69]; logrank P¼0.0001). Additional intracranial efficacy results are presented in the table. Radiological overall disease progression occurred in (BRG vs CRZ) 54 (39%) vs 74 (54%) pts as assessed by BIRC and 50 (36%) vs 84 (61%) pts as assessed by investigator; of these, brain was the first site of disease progression more frequently in pts treated with CRZ: (CRZ vs BRG) 31 (42%) vs 17 (31%) pts by BIRC and 22 (26%) vs 7 (14%) pts by investigator. Conclusions: BRG demonstrated superior intracranial activity vs CRZ in pts with ALK TKI-naive ALK+ NSCLC in ALTA-1L.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/j.annonc.2020.08.1614en
dc.titleIntracranial efficacy of brigatinib (BRG) vs crizotinib (CRZ): Updated results from the ALTA-1L trialen
dc.typeMeetings and Proceedingsen
dc.contributor.departmentMedical Oncology, Royal Marsden Hospital, London,en
dc.identifier.journalAnnals of Oncologyen
dc.description.noteen]
refterms.dateFOA2020-12-08T11:16:01Z


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