Ceritinib: Additional Phase I data
Additional data from an open-label, dose-escalation, international Phase I trial in 114 evaluable patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) showed that once-daily oral 400-750 mg LDK378 led to a median progression-free survival (PFS) of 6.9 months in patients who previously received Xalkori crizotinib (n=80) and 10.4 months in patients who had not previously received Xalkori (n=34). Additionally, LDK378 at a dose of >=400 mg led to an ORR of 56% in patients previously treated with Xalkori and 62% in patients not previously treated with Xalkori. Data were published in the New England Journal of Medicine. Novartis previously reported data from all 114 patients showing that LDK378 led to an ORR of 58%, including 1 complete response and 65 partial responses (see BioCentury, June 18, 2012 & June 24, 2013). ...