The event: Phase III study of Stimuvax in non-small cell lung cancer.
The timeline: Results of an interim analysis in the second half of the year.
The stakes: A chance for a coveted place atop the cancer immunotherapy mountaintop (joining Dendreon and Bristol Myers-Squibb.) Stimuvax is designed to work by stimulating a patient's immune system to seek out and destroy cancer cells that express a protein known as MUC1. The phase III study is enrolling 1,400 patients with unresectable stage III non-small cell lung cancer, randomized to treatment with Stimuvax or a placebo.
An interim analysis will be conducted after 75% of deaths in the study have taken place, which the company estimates will happen in the second half of the year. Three scenarios are possible: 1) the study continues to a final analysis in 2012; 2) the Stimuvax survival benefit is so great that the study is stopped early with a big win; or 3) Stimuvax treatment isn't working at all and won't help patients live longer so the study is halted for futility.