Chugai's ALK inhibitor Alecensa trial stopped early on good results

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519) says it has received a recommendation by an independent data monitoring committee (IDMC) that the J-ALEX Study, a Phase III study 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 (alectinib) compared to crizotinib (Pfizer’s Xalkori), says Chugai, which is majority owned by Swiss pharma giant Roche (ROG: SIX).

Alecensa was launched in Japan in 2014, and was approved by the US Food and Drug Administration under its accelerated approval system (The Pharma Letter December 14, 2015). The NSCLC) market is forecast to grow from $5.4 billion in 2014 to $12.7 billion in 2024, according to a new report from Decision Resources Group.