First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study

This RCT (n=376) reports improved median progression-free survival of 16.6 months in the ceritinib group vs 8.1 months in the chemotherapy group (HR 0.55; 95% CI 0.42–0.73; p<0.00001).

In a related editorial, the author states that “a potential limitation in the applicability of this study is that ceritinib was compared with chemotherapy rather than with crizotinib, which shortly after ASCEND-4 was initiated became standard first-line treatment based on the PROFILE 1014 first-line crizotinib trial. Nonetheless, the positive results of this study reinforce PROFILE 1014 in demonstrating that patients with ALK-rearranged non-small cell lung cancer (NSCLC) should receive initial therapy with an ALK inhibitor rather that chemotherapy and establishes ceritinib as an additional option for first-line therapy. Choice of agents for individual patients might be determined by balancing efficacy with toxicity”.

 

In the UK, ceritinib (Zykadia) is currently licensed for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC previously treated with crizotinib.