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Intracranial efficacy of brigatinib (BRG) vs crizotinib (CRZ): Updated results from the ALTA-1L trial
Popat, S. Kim, H. R. Ahn, M. J. Yang, J. C. H. 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. H.
Han, J. Y.
Hochmair, M. J.
Lee, K. H.
Delmonte, A.
Campelo, M. R. G.
Kim, D. W.
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Abstract
Background: 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.
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
Citation
Popat 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.