Treatment with ceritinib induced responses in patients with ALK-rearranged non-small cell lung cancer (NSCLC) who were previously treated with chemotherapy and crizotinib, according to a study published in the Journal of Clinical Oncology.1
The phase 1 ASCEND-1 trial demonstrated the efficacy of ceritinib in ALK-rearranged NSCLC, regardless of the presence of brain metastases of prior treatment with crizotinib. For this phase 2 study, investigators evaluated the efficacy and safety of ceritinib for patients previously treated with at least 1 platinum-based chemotherapy regimen and who had experienced disease progression during crizotinib treatment.
Researchers enrolled 140 patients, including those with asymptomatic or neurologically stable baseline brain metastases, each of whom had received 2 or more prior lines of treatment. All patients had received crizotinib.
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The investigator-assessed overall response rate was 38.6% (95% CI, 30.5-47.2). The disease control rate was 77.1% (95% CI, 69.3-83.8); median time to response was 1.8 months. The median duration of response was 9.7 months (95% CI, 7.1-11.1). Median progression-free survival was 5.7 months (95% CI, 5.4-7.6).
Frequently reported adverse events included nausea (81.4%), diarrhea (80.0%), and vomiting (62.9%), the majority of which were grade 1 or 2.
- Crino L, Ahn M-J, De Marinis F, et al. Multicenter phase II study of whole-body and intracranial activity with ceritinib in patients with ALK-rearranged non–small-cell lung cancer previously treated with chemotherapy and crizotinib: Results from ASCEND-2. J Clin Oncol. 2016 Jul 18. doi: 10.1200/JCO.2015.65.5936 [Epub ahead of print]