Ceritinib induced robust whole body responses in anaplastic lymphoma kinase (ALK) inhibitor-naive patients with ALK-rearranged non-small cell lung cancer (NSCLC), irrespective of the presence of baseline brain metastases, according to a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1

The pivotal ASCEND-1 trial demonstrated that treatment with the ALK inhibitor, ceritinib, was efficacious among ALK inhibitor-naive patients with ALK-rearranged NSCLC, including those with brain metastases at baseline. In the single-arm, open-label, phase 2 ASCEND-3 trial (ClinicalTrials.gov Identifier: NCT01685138), researchers evaluated the efficacy and safety of ceritinib among previously treated patients who had not received crizotinib.

Investigators enrolled 124 patients, of whom 98.4% had received prior antineoplastic regimens and 39.5% had baseline brain metastases.

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At a median follow-up of 23.1 months, median progression-free survival was 16.6 months (95% CI, 11.0-22.1) per investigator assessment and 18.4 months (95% CI, 10.9-26.3) by Blinded Independent Review Committee.

Investigators found that 57.1% of patients with baseline brain metastases and 74.7% of those without them achieved an overall response per investigator assessment; overall response rate per Independent Review Committee was 63.3% and 64.0%, respectively.

The study demonstrated an estimated 12-month overall survival rate of 85.1% (95% CI, 77.4-90.4) and a median duration of response of 22.1 months.

The most common adverse events were gastrointestinal, including diarrhea, nausea, and vomiting, and most were grade 1 to 2. A total of 11.3% of patients discontinued treatment due to adverse events.

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These findings were consistent with those of the ASCEND-1 trial that led to the U.S. Food and Drug Administration accelerated approval of ceritinib for patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib.                          


  1. Felip E, Orlov S, Park K, et al. Phase 2 study of ceritinib in ALKi-naïve patients (pts) with ALK-rearranged (ALK+) non-small cell lung cancer (NSCLC): Whole body responses in the overall pt group and in pts with baseline brain metastases (BM). Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.