WCLC 2016 | Results of ASCEND-4 trial of ceritinib versus chemotherapy in ALK+ NSCLC patients
Gilberto De Castro Jr., MD, PhD of the Institute of Cancer of São Paulo, Brazil talks about the Phase III ASCEND-4 trials of first-line ceritinib versus chemotherapy in patients with ALK rearranged (ALK+) non-small cell lung cancer (NSCLC) (NCT01828099). Currently there are many ALK inhibitors in development. The trial investigates a second-generation ALK inhibitor called ceritinib versus chemotherapy for the first time. In the trial, around 30% of all patients presented brain metastases, 40% had been submitted to previous radiation therapy, and 75% presented active brain metastases. The trial was randomized 1:1 between these two types of treatments, and achieved its primary endpoint; better progression-free survival (PFS) and a reduction in the progression disease risk in those patients treated with ceritinib was observed. The benefit of ceritinib was also demonstrated by a higher response rate in those patients with brain metastasis. PFS benefits were demonstrated in patients without brain metastases. The quality of life was also better for those patients treated with ceritinib in comparison to chemotherapy. Overall survival (OS) data is expected in 2018. Toxicities including gastrointestinal (GI), nausea, vomiting, and diarrhea were seen in 60% of patients. Most of these toxicities were grade 1 or grade 2 GI toxicities , which were mostly manageable and acceptable. The number of patients who needed to stop the treatment due to adverse events was lower for ceritinib. Recorded at the 2016 World Conference of Lung Cancer (WCLC) of the International Association for the Study of Lung Cancer (IASLC) in Vienna, Austria.
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