publication date: May. 1, 2014


Non-Small Cell Lung Cancer

LDK378 Demonstrates 58 Percent

Overall Response Rate in Phase I

A phase I single-arm study of LDK378 (ceritinib) demonstrated an overall response rate of 58 percent in patients with ALK-positive non-small cell lung cancer. Patients who received 400 mg or higher of LDK378 per day had a median progression-free survival of seven months.

The study, published in The New England Journal of Medicine, served as the basis for a regulatory application to the FDA, which has designated LDK378 as a breakthrough therapy.

The study evaluated 114 advanced anaplastic ALK+ NSCLC patients treated with LDK378, including patients who had progressed during or following treatment with a commonly prescribed ALK inhibitor, crizotinib, and those who had not received prior treatment with an ALK inhibitor.

“The majority of patients in the study experienced a clinical response to LDK378. In addition, responses were seen in untreated lesions in the central nervous system in patients who previously received crizotinib,” said lead investigator Alice Shaw, of Massachusetts General Hospital Cancer Center. “These results are important because most patients experience a disease relapse less than a year after starting crizotinib and have limited treatment options.”

The study enrolled 130 patients, including 122 patients with ALK+ NSCLC. Of 114 ALK+ NSCLC patients treated with LDK378 at 400 mg or higher per day, 80 had progressed during or following treatment with crizotinib, and 34 patients with ALK+ NSCLC were crizotinib-naïve. The maximum tolerated dose observed in the study was 750 mg per day.

The median duration of response for the 66 responding patients treated at 400 mg or higher per … Continue reading TCCL April – Non-Small Cell Lung Cancer

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