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    Brigatinib (BRG) vs crizotinib (CRZ) in ALK TKI-naive ALK plus NSCLC: Final results from ALTA-1L

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    Authors
    Popat, S.
    Kim, H. R.
    Ahn, M. J.
    Yang, J. C.
    Han, J. Y.
    Hochmair, M. J.
    Lee, K. H.
    Delmonte, A.
    Campelo, M. R. G.
    Kim, D. W.
    Griesinger, F.
    Felip, E.
    Califano, Raffaele
    Spira, A.
    Gettinger, S. N.
    Tiseo, M.
    Lin, H. M.
    Liu, Y.
    Vranceanu, F.
    Camidge, D. R.
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    Affiliation
    Medicine, Royal Marsden Hospital NHS Foundation Trust, London, UK
    Issue Date
    2021
    
    Metadata
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    Abstract
    Background In 2 planned interim analyses of ALTA-1L (NCT02737501), BRG BIRC-assessed PFS was superior to CRZ. We report final ALTA-1L results. Methods Patients (pts) with ALK TKI�naive advanced ALK+ NSCLC were enrolled and stratified by baseline (BL) brain metastases (BM) and prior chemotherapy (CT). One prior CT for advanced NSCLC and asymptomatic BM was allowed. Pts were randomized 1:1 to BRG 180 mg qd (7-day lead-in at 90 mg) or CRZ 250 mg BID. Pts in the CRZ arm were offered BRG at progression. Primary endpoint: BIRC-assessed PFS (RECIST v1.1). Secondary endpoints included confirmed iORR, iPFS by BIRC, OS, safety, and QoL. Results 275 pts randomized (BRG/CRZ, n=137/138); median age 58/60 y; prior CT 26%/27%; BL BM 29%/30%. As of 29 Jan 2021 (last patient contact), median follow-up was (BRG/CRZ): 40.4/15.2 mo, with 166 (73/93) PFS events. BIRC-assessed PFS HR was 0.48 (95% CI: 0.35�0.66, log-rank P<0.0001); BRG mPFS was 24.0 mo (95% CI: 18.4�43.2) vs CRZ 11.1 mo (95% CI: 9.1�13.0); 3-yr PFS rate was (BRG/CRZ) 43%/19%. Investigator-assessed PFS HR was 0.43 (95% CI: 0.31�0.58, mPFS 30.8 vs 9.2 mo). mDoR (BIRC) was 33/14 mo. Median OS was not reached in either group (events BRG/CRZ: 41/51; HR: 0.81 [95% CI: 0.53�1.22]; log rank P=0.3311); 3-yr OS was 71%/68%. In pts with BL BM, OS HR was 0.43 (95% CI: 0.21�0.89; Table); in pts with no BL BM, 1.16 (0.69�1.93). Most common grade ?3 TEAEs: BRG: increased CPK (26%) and lipase (15%), hypertension (14%); CRZ: increased ALT (10%), lipase, (8%), AST (7%). Any grade ILD/pneumonitis (BRG/CRZ): 4.4%/2.2%; discontinuation due to AE: 13.2%/8.8%. Median time to worsening in pt-reported global health status/QoL was (BRG/CRZ) 26.7/8.3 mo; HR: 0.69 (95% CI: 0.49�0.98). Conclusions BRG demonstrated durable overall and intracranial efficacy, and the tolerability profile remained consistent and manageable despite extended treatment duration, confirming BRG as an effective standard-of-care treatment in pts with treatment-naive ALK+ NSCLC.
    Citation
    Popat S, Kim HR, Ahn M-J, Yang JC, Han J-Y, Hochmair MJ, et al. 1195P Brigatinib (BRG) vs crizotinib (CRZ) in ALK TKI�naive ALK+ NSCLC: Final results from ALTA-1L. Vol. 32, Annals of Oncology. Elsevier BV; 2021. p. S954�5.
    Journal
    Annals of Oncology
    URI
    http://hdl.handle.net/10541/624719
    DOI
    10.1016/j.annonc.2021.08.1800
    Additional Links
    https://dx.doi.org/10.1016/j.annonc.2021.08.1800
    Type
    Other
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.annonc.2021.08.1800
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