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Brigatinib (BRG) vs crizotinib (CRZ) in Asian vs non-Asian patients (pts): Update from ALTA-1L
Ahn, M. J. Kim, H. R. Yang, J. C. H. Han, J. Y. Li, J. Y. C. Hochmair, M. J. Chang, G. C. Delmonte, A. Lee, K. H. Campelo, M. R. G.
Ahn, M. J.
Kim, H. R.
Yang, J. C. H.
Han, J. Y.
Li, J. Y. C.
Hochmair, M. J.
Chang, G. C.
Delmonte, A.
Lee, K. H.
Campelo, M. R. G.
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Abstract
Background: We report updated data with BRG vs CRZ in Asian vs non-Asian pts with
ALK TKIenaive advanced ALK+ NSCLC from ALTA-1L (NCT02737501) second interim
analysis (IA2).
Methods: Pts were stratified by baseline (BL) CNS metastases and prior chemotherapy
(CT). All pts had brain MRI at each tumor assessment. Pts were randomized
1:1 to BRG 180 mg qd (7-day lead-in at 90 mg) or CRZ 250 mg bid. Primary endpoint:
blinded independent review committee (BIRC)eassessed PFS (RECIST v1.1). Secondary
endpoints by BIRC included confirmed ORR, median duration of response (mDoR)
in confirmed responders, and intracranial PFS (iPFS).
Results: 275 pts were randomized; 108 Asian (BRG/CRZ, n¼59/49), 167 non-Asian
(n¼78/89); median age: Asian 55/56 y; non-Asian 60/60 y. 32/24% of Asian pts vs 22/
28% of non-Asian pts received prior CT; 36/33% vs 24/28% had BL CNS metastases. As
of IA2 data cutoff (28 Jun 2019), there were (BRG vs CRZ) 26 vs 31 BIRC-assessed PFS
events in Asian pts and 37 vs 56 in non-Asian pts. In Asian pts, median BIRC-assessed
PFS (mPFS) was 24.0 mo (95% CI 18.4enot reached [NR]) with BRG vs 11.1 mo (9.2e
15.6) with CRZ (HR 0.38 [95% CI 0.22e0.65]; log-rank P¼0.0006). The PFS result is also
in favor of BRG in non-Asian pts. Confirmed ORR (95% CI) in Asian pts was (BRG/CRZ)
78% (65e88)/71% (57e83), P¼0.3397; in non-Asian pts 71% (59e80)/56% (45e67),
P¼0.0556. Duration of confirmed response and iPFS were both longer for BRG in both
Asian and non-Asian pts. Safety profile was similar in Asian vs non-Asian pts.
Conclusions: BRG showed sustained improvement in systemic and intracranial PFS vs
CRZ in Asian and non-Asian pts with ALK inhibitorenaive ALK+ NSCLC, with numerically
better BIRC-assessed PFS HRs in Asian pts.
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
Citation
Ahn MJ, Kim HR, Yang JCH, Han JY, Li JYC, Hochmair MJ, et al. 1304P Brigatinib (BRG) vs crizotinib (CRZ) in Asian vs non-Asian patients (pts): Update from ALTA-1L. Annals of Oncology. 2020;31:S843-S4.