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ASCEND-7 Trial: Use of Ceritinib for ALK-Positive Lung Cancer

By: Lauren Harrison, MS
Posted: Wednesday, November 6, 2019

The ALK inhibitor ceritinib has shown “meaningful” efficacy for patients with ALK-positive non–small cell lung cancer (NSCLC) that has metastasized to the leptomeninges, according to data from the ASCEND-7 study. Fabrice Barlesi, MD, PhD, of Aix-Marseille University in France, presented the work he completed with colleagues at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona (Abstract 390O). It was also published in Annals of Oncology.

This phase II trial of ceritinib enrolled 18 patients with confirmed ALK-positive NSCLC with radiologically or cytologically confirmed leptomeningeal metastasis and one or more extracranial measurable lesions. Of the enrolled patients, 14 had brain metastases and 8 had measurable brain masses at baseline. Most patients (88.9%) had previously received crizotinib, and 38.9% had received prior brain radiotherapy.

The median duration of ceritinib treatment was 18.1 weeks, the whole-body overall response rate was 16.7%, and the median duration of response was 5.5 months. The median progression-free survival was 5.2 months and was considered to be clinically significant by the investigators. The overall intracranial response rate for the patients with measurable brain metastases at baseline was 12.5%, whereas the extracranial overall response rate was 22.2% for all patients.

All of the 18 patients involved in the trial reported adverse events of some grade. Grade 3 or 4 adverse events noted in more than 10% of patients included increased alanine aminotransferase (22.2%), hyperglycemia (16.7%), increased gamma-glutamyl transferase (11.1%), pneumonia (11.1%), and increased lipase (11.1%).

Disclosure: For full disclosure information for the study authors, visit academic.oup.com.



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