Chugai's late-stage study of Alecensa in lung cancer stopped early after successfully meeting primary endpoint

• Based on the recommendation of an independent data monitoring committee, Chugai Pharmaceutical's (OTCPK:CHGCF)(OTCPK:CHGCY)(OTCQX:RHHBY) Phase 3 clinical trial, J-ALEX, assessing Alecensa (alectinib) compared to crizotinib [Pfizer's (NYSE:PFE) XALKORI] in patients with ALK-positive non-small cell lung cancer (NSCLC) has been stopped early on the basis on meeting its primary endpoint at a pre-planned interim analysis. Results from the Japan-based study showed patients treated with Alecensa lived significantly longer with their cancer worsening (progression-free survival) than those treated with crizotinib.
• J-ALEX was a 207-subject open-label trial in patients ALK fusion protein-positive NSCLC who had not undergone chemotherapy or had one regimen of chemo.
• The results will be presented at a future medical conference.
• The U.S. FDA approved Alecensa in December. It was cleared in Japan in July 2014. Roche licensed it from Chugai in 2012.