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    Systemic and intracranial efficacy of brigatinib vs.crizotinib: updated results from the ALTA-1L Trial

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    Authors
    Popat, S.
    Kim, H. R.
    Ahn, M. J.
    Yang, J. C. H.
    Han, J. Y.
    Hochmair, M.
    Lee, K. H.
    Delmonte, A.
    Campelo, M. R. G.
    Kim, D. W.
    Griesinger, F.
    Felip, E.
    Califano, Raffaele
    Spira, A.
    Gettinger, S.
    Tiseo, M.
    Lin, H.
    Liu, Y.
    Zhang, P.
    Camidge, D. R.
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    Affiliation
    Royal Marsden Hospital, London
    Issue Date
    2021
    
    Metadata
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    Abstract
    Background: At ALTA-1L (NCT02737501) first interim analysis (IA1), brigatinib demonstrated superior BIRC-assessed PFS and iPFS vs crizotinib. We report IA2 results, planned at w75% of 198 expected PFS events. Methods: Patients with TKI-naive advanced ALK+ NSCLC were randomized 1:1 to brigatinib 180 mg qd (7-day lead-in at 90 mg) or crizotinib 250 mg bid. Endpoints: Primary, BIRC-assessed PFS (RECIST v1.1); secondary included confirmed ORR and iORR, and iPFS (BIRC). Results: 275 patients were randomized (brigatinib/crizotinib, n¼137/ 138); median age, 58/60 years; prior chemotherapy, 26%/27%; baseline brain metastases (BIRC), 34%/36%; brain radiotherapy, 13%/ 14% (WBRT/SRS balanced across arms). At data cutoff (28 June 2019, median follow-up [brigatinib/crizotinib], 24.9/15.2 months, 150 PFS events): BIRC-assessed PFS HR, 0.49 (95% CI, 0.35e0.68, log-rank P<0.0001); brigatinib mPFS, 24.0 months (95% CI, 18.5eNE) vs crizotinib 11.0 months (9.2e12.9). Investigator-assessed PFS HR was 0.43 (95% CI, 0.31e0.61, median 29.4 vs 9.2 months). OS was immature (total events: 33/37, brigatinib/crizotinib). In patients with baseline brain metastases, PFS HR was 0.25; data were less mature in brigatinib patients without brain metastases. Additional results in Table. Radiological overall disease progression occurred in (brigatinib vs crizotinib) 54 (39%) vs 74 (54%) patients (BIRC) and 50 (36%) vs 84 (61%) (investigator); of these, brain was first site of progression more frequently with crizotinib vs brigatinib: 31 (42%) vs 17 (31%) patients (BIRC); 22 (26%) vs 7 (14%) (investigator). Most common TEAEs grade 3: brigatinib: increased CPK (24.3%) and lipase (14.0%), hypertension (11.8%); crizotinib: increased ALT (10.2%), AST (6.6%), lipase (6.6%). Brigatinib significantly delayed median time to deterioration vs crizotinib for global health score/QoL (log-rank P¼0.0485), emotional and social functioning, fatigue, nausea and vomiting, appetite loss, constipation. Conclusions: Brigatinib demonstrated superior systemic and intracranial efficacy vs crizotinib in all patients with TKInaive ALK+ NSCLC and in patients with baseline brain metastases.
    Citation
    Popat S, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair M, et al. Systemic and intracranial efficacy of brigatinib vs.crizotinib: updated results from the ALTA-1L Trial. Journal of Thoracic Oncology. 2021;16(1):S8-S9
    Journal
    Journal of Thoracic Oncology
    URI
    http://hdl.handle.net/10541/623901
    Type
    Meetings and Proceedings
    Language
    en
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