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ASCEND-7: Ceritinib for Brain Metastases From ALK-Positive Lung Cancer

By: Nahae Kim, MPH
Posted: Friday, November 15, 2019

The results of the ASCEND-7 study, presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona (Abstract 1478O), support the use of ceritinib for patients with brain metastases from ALK-positive non–small cell lung cancer (NSCLC). Laura Q. Chow, MD, of the University of Texas at Austin, Dell Medical School, and colleagues reported on the whole-body, intracranial, and extracranial effects of ceritinib in this patient population.

“These are exciting data from one of the first studies to be presented that evaluates ceritinib in patients with active brain metastases,” Dr. Chow told The ASCO Post. “Although intracranial responses have been reported with other second-generation ALK inhibitors, the eligible criteria were not homogeneous across studies.”

This phase II study enrolled 138 patients diagnosed with ALK-positive NSCLC with newly diagnosed or progressive active brain metastases, treated in four arms. Arm 1 included 42 patients pretreated with brain radiotherapy and an ALK inhibitor. Arm 2 included 40 patients pretreated with an ALK inhibitor alone. Arm 3 included 12 patients pretreated with brain radiotherapy alone. Arm 4 included 44 patients who were naive to both prior brain radiotherapy and an ALK inhibitor.

The whole-body overall response rate was 35.7%, 30%, 50%, and 59.1% for the respective treatment arms. The intracranial overall response rate for the respective treatment arms were 39.3%, 27.6%, 28.6%, and 51.5%. The safety of ceritinib was consistent with prior reports, with common adverse events including diarrhea, nausea, increase of alanine aminotransferase and aspartate aminotransferase, and decreased appetite. No new or unexpected safety issues were reported.

Disclosure: For full disclosures of study authors, visit esmo.org.



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