Phase III study of Alecensa (alectinib) in non small cell lung cancer meets endpoint and halted early- Chugai Pharmaceutical

Chugai Pharmaceutical has received a recommendation by an independent data monitoring committee (IDMC) that the J-ALEX Study, a phase III study of Alecensa (alectinib) targeting ALK fusion gene positive non-small cell lung cancer (NSCLC) being conducted in Japan, should be stopped early as the study met its primary endpoint at a pre-planned interim analysis. The study showed that patients lived significantly longer without disease worsening (progression-free survival, PFS) when treated with Alecensa compared to crizotinib.

Chugai carried out a prospectively defined interim analysis of the J-ALEX study, and had an IDMC examine the results. Since the results showed that Alecensa significantly prolonged the PFS to a higher extent than anticipated, the committee decided to recommend an early discontinuation of the study so all patients can beenfit. The safety issues of Alecensa have not been pointed out. The data of the J-ALEX study will be presented at a future medical meeting.