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Brigatinib (BRG) vs crizotinib (CRZ) in ALK TKI-naive ALK plus NSCLC: Final results from ALTA-1L
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.
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.
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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.
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Date
2021
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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.