Dataset Information

Ceritinib Efficacy and Safety in Treatment-Naive Asian Patients With Advanced ALK-Rearranged NSCLC: An ASCEND-4 Subgroup Analysis.

ABSTRACT:

Introduction

In the phase 3 ASCEND-4 study, ceritinib exhibited improved progression-free survival (PFS) by Blinded Independent Review Committee (BIRC) assessment versus the standard first-line chemotherapy in patients with advanced ALK-rearranged NSCLC. Here, we assessed the efficacy and safety of ceritinib in the subgroup of Asian patients from the ASCEND-4 trial.

Methods

Treatment-naive patients with stage IIIB or IV ALK-rearranged nonsquamous NSCLC were randomized in a one-to-one ratio to receive either oral ceritinib 750 mg/day (fasted) daily or intravenous chemotherapy ([cisplatin 75 mg/m² or carboplatin area under the curve 5-6 plus pemetrexed 500 mg/m²] 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

Ceritinib was effective and safe in treatment-naive Asian patients with advanced ALK-rearranged NSCLC. The findings were largely consistent with that of the overall study population.

SUBMITTER: Tan DSW

PROVIDER: S-EPMC8474482 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Ceritinib Efficacy and Safety in Treatment-Naive Asian Patients With Advanced <i>ALK</i>-Rearranged NSCLC: An ASCEND-4 Subgroup Analysis.

Tan Daniel S W DSW Geater Sarayut S Yu Chong-Jen CJ Tsai Chun-Ming CM Hsia Te-Chun TC Chen Jun J Lin Meng-Chih MC Lu You Y Sriuranpong Virote V Yang Cheng-Ta CT Sen Paramita P Branle Fabrice F Shi Michael M Wu Yi-Long YL

JTO clinical and research reports 20201217 3

<h4>Introduction</h4>In the phase 3 ASCEND-4 study, ceritinib exhibited improved progression-free survival (PFS) by Blinded Independent Review Committee (BIRC) assessment versus the standard first-line chemotherapy in patients with advanced <i>ALK-</i>rearranged NSCLC. Here, we assessed the efficacy and safety of ceritinib in the subgroup of Asian patients from the ASCEND-4 trial.<h4>Methods</h4>Treatment-naive patients with stage IIIB or IV <i>ALK-</i>rearranged nonsquamous NSCLC were randomize ...[more]

PMID: 34589995

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