Ceritinib Efficacy and Safety in Treatment-Naive Asian Patients With Advanced ALK-Rearranged NSCLC: An ASCEND-4 Subgroup Analysis
Journal
JTO Clinical and Research Reports
Journal Volume
2
Journal Issue
3
Pages
100131
Date Issued
2021
Author(s)
Tan D.S.W.
Geater S.
Tsai C.-M.
Hsia T.-C.
Chen J.
Lin M.-C.
Lu Y.
Sriuranpong V.
Yang C.-T.
Sen P.
Branle F.
Shi M.
Wu Y.-L.
Abstract
INTRODUCTION: rearranged NSCLC. Here, we assessed the efficacy and safety of ceritinib in the subgroup of Asian patients from the ASCEND-4 trial. METHODS: ] every three wk, followed by pemetrexed maintenance). The primary end point was PFS by BIRC assessment. RESULTS: Of 376 randomized patients, 158 (42.0%) were Asian (ceritinib arm: N = 76; chemotherapy arm: N = 82). The median time from randomization to the cutoff date (June 24, 2016) was 18.3 months (range = 13.5-34.2) in the Asian subgroup. The median PFS (by BIRC assessment) was 26.3 months (95% confidence interval [CI]: 8.6-not estimable) and 10.6 months (95% CI: 6.7-15.0), with an estimated 34% risk reduction in PFS (hazard ratio = 0.66, 95% CI: 0.41-1.05) in the ceritinib arm versus chemotherapy arm. The most common adverse events of any grade were diarrhea (85.5%), increased alanine aminotransferase and vomiting (73.7% each), and increased aspartate aminotransferase and nausea (69.7% each) in the ceritinib arm, and nausea (49.3%), vomiting (42.7%), and anemia (40.0%) in the chemotherapy arm. CONCLUSION: rearranged NSCLC. The findings were largely consistent with that of the overall study population.
SDGs
Publisher
Elsevier Inc.
Type
journal article