ASCEND-5: Ceritinib vs Chemotherapy in Advanced ALK-Rearranged NSCLC
The next-generation ALK inhibitor ceritinib significantly improved progression-free survival over chemotherapy in patients with advanced, previously treated ALK-rearranged non–small cell lung cancer, according to the results of the phase III ASCEND-5 trial. In The Lancet Oncology, Alice T. Shaw, MD, of Massachusetts General Hospital, Boston, and colleagues concluded their findings establish ceritinib as a more effective treatment option than chemotherapy in this patient population.
A total of 231 patients from 99 sites in 20 countries took part in this open-label trial. Half of them received ceritinib, and the others received chemotherapy (investigator choice of pemetrexed or docetaxel). The median follow-up was 16.5 months.
Median progression-free survival (the primary study endpoint) was 5.4 months in those treated with ceritinib and 1.6 months in those treated with chemotherapy (hazard ratio = 0.49, P<.0001). In chemotherapy patients who received pemetrexed, median progression free survival was 2.9 months, compared with 1.5 months in chemotherapy patients who received docetaxel.
The most common grade 3 or 4 adverse events reported with the use of ceritinib were increased alanine transaminase, increased gamma-glutamyltransferase, and increased aspartate transaminase.