Ceritinib Displays Whole Body, Intracranial Efficacy in Crizotinib-treated Patients
Ceritinib treatment demonstrated clinically meaningful whole body and intracranial activity with an acceptable tolerability profile.
Ceritinib treatment demonstrated clinically meaningful whole body and intracranial activity with an acceptable tolerability profile in patients with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung (NSCLC) and brain metastases previously treated with crizotinib.1
Bone metastases are frequent sites of disease progression in patients with ALK mutation-positive NSCLC, including those who have received crizotinib therapy. Because ceritinib displayed 20-fold greater potency than crizotinib in vitro, researchers sought to evaluate the efficacy of ceritinib in crizotinib-pretreated patients with brain metastases in the phase 1 ASCEND-1 trial and the phase 2 ASCEND-2 study.
Researchers enrolled 98 and 100 patients with baseline brain metastases into ASCEND-1 and ASCEND-2, respectively. All patients received ceritinib 750 mg/day orally. Most patients had previously received chemotherapy. A total of 69.4% of patients in ASCEND-1 and 72.0% of patients in ASCEND-2 had received prior radiotherapy to the brain.
Results showed that the overall whole body response rate was 41.8% (95% CI, 31.9 - 52.2) in ASCEND-1 and 32.0% (95% CI, 23.0 - 42.1) in ASCEND-2. Median progression-free survival was 6.7 months (95% CI, 5.4 - 9.5) and 6.8 months (95% CI, 5.4 - 7.4), respectively.
Researchers found that the overall intracranial response rate using pooled data was 37.7% (95% CI, 37.7 - 51.0) with a median intracranial duration of response of 12.8 months (95% CI, 6.9 - not evaluable). The intracranial disease control rate was 73.8% (95% CI, 60.9 - 84.2).
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In terms of safety, the most common adverse events were nausea, diarrhea, and vomiting. A total of 17 patients discontinued treatment due to treatment-related toxicity.
- Felip E, Crinó L, Kim D, et al. Whole body and intracranial efficacy of ceritinib in patients (pts) with crizotinib (CRZ) pretreated, ALK-rearranged (ALK+) non-small cell lung cancer (NSCLC) and baseline brain metastases (BM): results from ASCEND-1 and ASCEND-2 trials. Poster presentation at: European Lung Cancer Conference 2016; April 13-16, 2016; Geneva, Switzerland.