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    Brigatinib (BRG) vs crizotinib (CRZ) in anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor-naive ALK plus non-small cell lung cancer (NSCLC): ALTA-1L final results

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    Authors
    Tiseo, M.
    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. I.
    Gettinger, S. N.
    Lin, H. M.
    Liu, Y.
    Vranceanu, F.
    Camidge, R.
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    Affiliation
    Medical Oncology Department, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy
    Issue Date
    2022
    
    Metadata
    Show full item record
    Abstract
    Background In ALTA-1L planned interim analyses, BRG progression-free survival (PFS) by blinded independent review committee (BIRC) was superior to CRZ. We report final ALTA-1L (NCT02737501) results. Methods Patients (pts) were randomized 1:1 to BRG 180 mg qd (7-day lead-in at 90 mg) or CRZ 250 mg bid. Primary endpoint: PFS by BIRC. Secondary endpoints included intracranial PFS (iPFS; BIRC), overall survival (OS), safety, quality of life (QoL). Results 275 pts randomized (BRG/CRZ, n=137/138); median age 58/60 y; prior chemotherapy (CT) 26%/27%; median CT duration, 71/73 days; baseline brain metastases (BL BM) 29%/30%. As of 29 Jan 2021 (last patient contact), median follow-up was 40.4/15.2 mo, with 166 (73/93) PFS events. BIRC PFS hazard ratio (HR) was 0.48 (95% CI: 0.35–0.66, log-rank P<0.0001); median PFS was 24.0 (95% CI: 18.4–43.2)/11.1 (9.1–13.0) mo; 3-yr PFS rate, 43%/19%. PFS HR by investigator was 0.43 (0.31–0.58; median PFS 30.8 vs 9.2 mo). Median duration of response (DoR) was 33/14 mo by BIRC and 37/11 mo by investigator. Median OS was not reached in either group (events: 41/51; HR 0.81 [0.53–1.22]; 3-yr OS 71%/68%. In pts with BL BM, PFS HR 0.25 (0.14–0.46); OS HR 0.43 (0.21–0.89; Table). Most common grade ≥3 treatment-emergent adverse events (AE): BRG: increased creatine phosphokinase (26%) and lipase (15%), hypertension (14%); CRZ: increased alanine aminotransferase (10%), lipase, (8%), aspartate aminotransferase (7%). Any-grade interstitial lung disease/pneumonitis: 5.9%/2.2%; discontinuation due to AE: 13.2%/8.8%. Median time to worsening in pt-reported global health status/QoL was 26.7/8.3 mo; HR 0.69 (0.49–0.98). Table: 29P Efficacya BRG CRZ P BL brain metastases Measurable, n 18 23 Confirmed iORR, % 78 (52–94b) 26 (10–48b) 0.0014c Median iDoRd, mo 28 (6–NEb) 9 (4–NEb) Any, n 40e 41e PFS events, n (%) 24 (60) 31 (76) HR 0.25 (0.14–0.46b) <0.0001f OS events, n (%) 11 (28) 22 (54) 3-yr OS, % 74 (57–85b) 55 (38–69b) HR 0.43 (0.21–0.89b) 0.0199f 47a 49a iPFS events, n (%) 27 (57) 35 (71) HR 0.29 (0.17–0.51b) <0.0001f , n 97e 97e PFS events, n (%) 49 (51) 62 (64) HR 0.62 (0.43–0.91b) 0.0131f OS events, n (%) 30 (31) 29 (30) 3-yr OS, % 70 (59–78b) 73 (62–81b) HR 1.16 (0.69–1.93b) 0.6027f 90a 89a iPFS events, n (%) 25 (28) 23 (26) HR 0.70 (0.39–1.26b) 0.2410f a BIRC; b 95% CI; c CMH test; d Confirmed responders; e Investigator; f Log-rank Conclusions BRG demonstrated durable overall and intracranial efficacy with manageable tolerability with extended treatment, confirming BRG as a standard of care in treatment-naive ALK+ NSCLC.
    Citation
    Tiseo M, Popat S, Kim HR, Ahn MJ, Yang JC, Han JY, et al. 29P Brigatinib (BRG) vs crizotinib (CRZ) in anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor-naive ALK+ non-small cell lung cancer (NSCLC): ALTA-1L final results. Vol. 33, Annals of Oncology. Elsevier BV; 2022. p. S44–5.
    Journal
    Annals of Oncology
    URI
    http://hdl.handle.net/10541/625231
    DOI
    10.1016/j.annonc.2022.02.038
    Additional Links
    https://dx.doi.org/10.1016/j.annonc.2022.02.038
    Type
    Meetings and Proceedings
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.annonc.2022.02.038
    Scopus Count
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