Brigatinib vs crizotinib in the phase 3 ALTA-1L trial: Updated results
Griesinger, F. Kim, H. R. Ahn, M. J. Yang, J. C. Han, J. Y. Hochmair, M. Lee, K. H. Delmonte, A. Campelo, M. R. G. Kim, D. W.
Griesinger, F.
Kim, H. R.
Ahn, M. J.
Yang, J. C.
Han, J. Y.
Hochmair, M.
Lee, K. H.
Delmonte, A.
Campelo, M. R. G.
Kim, D. W.
Citations
Altmetric:
Abstract
Introduction: We report results of the second interim analysis from
ALTA-1L (NCT02737501), planned at 75% of 198 expected events.
Methods: Patients with anaplastic lymphoma kinase (ALK) tyrosine kinase
inhibitor (TKI)-naive advanced ALK-positive non-small cell lung
cancer (ALK+ NSCLC) were enrolled. One prior chemotherapy for advanced
NSCLC and asymptomatic brain metastases were allowed. Patients
were randomized 1:1 to brigatinib 180 mg qd with 7-day lead-in
at 90 mg or crizotinib 250 mg BID. The primary endpoint was blinded
independent review committee (BIRC)-assessed progression-free survival (PFS; RECIST v1.1). Secondary endpoints (by BIRC) included confirmed
objective response rate (ORR) and intracranial ORR (iORR), as well as
intracranial PFS (iPFS).
Results: 275 patients were randomized (brigatinib/crizotinib, n=137/138);
median age was 58/60 years. In total, 26%/27% received prior chemotherapy;
29%/30% had baseline brain metastases. As of 28 June 2019, median
follow-up for brigatinib/crizotinib was 24.9/15.2 mo, with 150 PFS events.
BIRC-assessed PFS HR was 0.49 (95% CI 0.35-0.68; log-rank P< 0.0001);
median PFS (mPFS) was 24.0 mo (18.5-not estimable [NE]) for brigatinib
vs 11.0 mo (9.2-12.9) for crizotinib. Investigator-assessed PFS HR was 0.43
(0.31-0.61; mPFS 29.4 vs 9.2 mo). Overall survival was immature (events:
33/37, brigatinib/crizotinib). Early benefit for brigatinib was observed in
patients with baseline brain metastases; 6 mo PFS by BIRC was 89.0%
for brigatinib and 47.5% for crizotinib. Independent of prior chemotherapy,
the subgroup of patients with baseline brain metastases consistently
benefited more than those without baseline brain metastases. Table shows
additional efficacy data.
Conclusions: Brigatinib showed superior PFS vs crizotinib in all patient
subgroups with ALK TKI-naive ALK+ NSCLC. Based on these data,
brigatinib has been approved by the EMA in 2020 for first-line therapy.
Description
Date
2020
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Griesinger F, Kim HR, Ahn MJ, Yang JC, Han JY, Hochmair M, et al. Brigatinib vs crizotinib in the phase 3 ALTA-1L trial: Updated results. Oncology Research and Treatment. 2020;43(SUPPL 4):142-