Ceritinib Produces Durable Whole-body Responses in NSCLC

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Ceritinib produced durable whole-body responses and has intracranial activity in patients with non-small cell lung cancer.
Ceritinib produced durable whole-body responses and has intracranial activity in patients with non-small cell lung cancer.

Ceritinib produced durable whole-body responses and has intracranial activity in patients with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) who have received crizotinib, or as an alternative to crizotinib, a study published in the journal The Lancet Oncology has shown.1

ALK-rearranged NSCLC is sensitive to ALK inhibitors such as crizotinib, but resistance frequently develops, often with metastases to the brain. Ceritinib is a more potent ALK inhibitor than crizotinib in vitro, crosses the blood–brain barrier in vivo, and shows clinical responses in patients with crizotinib-resistant disease.

Therefore, researchers sought to evaluate whole-body activity of ceritinib in both ALK inhibitor-pretreated and ALK inhibitor-naïve patients with ALK-rearranged NSCLC.

For the open-label, phase 1 ASCEND-1 trial, researchers enrolled 255 patients with ALK-rearranged locally advanced or metastatic NSCLC that had progressed despite standard therapy or had no effective standard therapy option. All participants had at least 1 measurable lesion at baseline. Patients received ceritinib 750 mg orally daily.

Results showed that 72% (95% CI, 61 - 82) of the 83 ALK inhibitor-naïve patients and 56% (95% CI, 49 - 64) of the 163 ALK inhibitor-pretreated patients. Median duration of response was 17.0 months (95% CI, 11.3 - not estimable) and 8.3 months (95% CI, 6.8 - 9.7), respectively.

Furthermore, researchers found that median progression-free survival was 18.4 months (95% CI, 11.1 - not estimable) in ALK inhibitor-naïve patients and 6.9 months (95% CI, 5.6 - 8.7) in ALK inhibitor-pretreated patients.

In terms of brain metastases, 79% of the 19 ALK inhibitor-naïve patients and 65% of the 75 ALK inhibitor-pretreated patients with retrospectively confirmed brain metastases achieved intracranial disease control.

A confirmatory phase 2 clinical trial is ongoing to assess ceritinib activity in patients with ALK-rearranged NSCLC and brain or leptomeningeal metastases.

RELATED: Geriatric Assessment for Older Patients With Lung Cancer Provides No Survival Advantage

Ceritinib is a kinase inhibitor indicated for the treatment of patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. This indication was approved under accelerated approval based upon tumor response rate and duration of response.

Reference

  1. Kim D-W, Mehra R, Tan DSW, et al. Activity and safety of ceritinib in patients with ALK-rearranged non-small-cell lung cancer (ASCEND-1): updated results from the multicentre, open-label, phase 1 trial [published online ahead of print March 10, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00614-2.

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