Ceritinib in patients with advanced, crizotinib-treated, anaplastic lymphoma kinase-rearranged NSCLC: Japanese subset

Abstract

Introduction

Anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer is sensitive to tyrosine kinase inhibitors; however, resistance can develop. Data are presented from the phase II trial (ASCEND-2) evaluating efficacy and safety in a subset of Japanese patients with ALK-rearranged non-small cell lung cancer previously treated with platinum-based chemotherapy, who experienced disease progression on crizotinib.

Methods

Patients with advanced ALK-rearranged non-small cell lung cancer, including those with asymptomatic or neurologically stable baseline brain metastases, received oral ceritinib 750 mg/day. Whole-body and intracranial responses were assessed by investigator and Blinded Independent Review Committee (RECIST v1.1). Safety and tolerability were also investigated.

Results

All 24 Japanese patients had received ≥2 previous treatment regimens, with crizotinib the last therapy received prior to ceritinib. Median duration of ceritinib exposure was 8.1 (range: 0.2–12.5) months. Overall response rate was 45.8% (95% confidence interval: 25.6–67.2). Other efficacy endpoints included disease control rate (79.2% [95% confidence interval: 57.8–92.9]), time to response (median 1.9 months [range: 1.7–3.5]), duration of response (median 9.2 months [95% confidence interval: 4.0–not estimable]) and progression-free survival (median 6.6 months [95% confidence interval: 3.7–9.3]). Of the four patients with active baseline target brain lesions, two achieved an intracranial partial response (50%). The most commonly reported adverse events (majority grade 1/2) were nausea (91.7%), diarrhea (83.3%) and vomiting (83.3%).

Conclusions

This study demonstrates the clinical activity and manageable tolerability of ceritinib in a Japanese subset of chemotherapy- and crizotinib-pretreated patients with ALK-rearranged non-small cell lung cancer who progressed on crizotinib, as was shown in the whole ASCEND-2 study population.ClinicalTrials.gov identifier: NCT01685060

from #ORL-AlexandrosSfakianakis via ola Kala on Inoreader http://ift.tt/2tBqiNa
via IFTTT