New data from two phase 2 studies showed ceritinib (Zykadia) shrank tumors in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who had received previous treatment with an ALK inhibitor and in those receiving an ALK inhibitor for the first time.
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The results of the Zykadia studies-ASCEND-2 and ASCEND-3 were presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
ASCEND-2 was a single-arm, open-label, multicenter phase 2 study of ceritinib in adult patients with ALK+ NSCLC previously treated with chemotherapy and crizotinib. At the August 13, 2014 data cut-off, 140 patients receiving oral ceritinib 750 mg daily had enrolled worldwide. In these patients, the overall response rate (ORR) was 38.6%, based on investigator assessment, following treatment with Zykadia. The most frequent adverse events with incidence of >50% were nausea (81.4%), diarrhea (80.0%) and vomiting (62.9%). The most frequent adverse events with incidence of >20% were nausea (81.4%), diarrhea (80.0%), vomiting (62.9%), increased alanine aminotransferase (43.6%), decreased appetite (40.7%), fatigue (36.4%), decreased weight (34.3%), increased aspartate aminotransferase (32.1%), abdominal pain (31.4%), constipation (28.6%), cough (21.4%), pyrexia (20.7%) and dyspnea (20.7%).
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ASCEND-3 evaluated adult patients with ALK+ NSCLC who had received up to 3 lines of chemotherapy and had no prior experience with an ALK inhibitor; in these patients, the ORR was 63.7%, based on investigator assessment, following treatment with Zykadia. The most frequent adverse events with incidence of >50% were diarrhea (82.3%), nausea (74.2%) and vomiting (66.9%). The most frequent adverse events with incidence of >20% were diarrhea (82.3%), nausea (74.2%), vomiting (66.9%), decreased appetite (49.2%), increased alanine aminotransferase (40.3%), abdominal pain (33.1%), fatigue (32.3%), increased aspartate aminotransferase (30.6%), decreased weight (29.0%), increased gamma-glutamyl transferase (GGT) (26.6%), increased blood creatinine (21.0%) and increased blood alkaline phosphatase (20.2%).
Comparable ORR results were observed in patients with ALK+ NSCLC who entered the studies with brain metastases: 33.0% in ASCEND-2 and 58.0% in ASCEND-3.
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