NovaRx's Lucanix misses NSCLC endpoint

NovaRx Corp. (San Diego, Calif.) said Lucanix belagenpumatucel-L plus best supportive care (BSC) as maintenance therapy missed the primary endpoint of improving median overall survival (OS) vs. placebo plus BSC in the Phase III STOP trial to treat advanced non-small cell lung cancer (NSCLC) (20.3 vs. 17.8 months, p=0.594). The double-blind, international trial enrolled 532 patients with stage III/IV NSCLC who have responded to, or have stable disease following one regimen of, first-line platinum-based chemotherapy. NovaRx said the endpoint was not met due to enrollment of patients more than 12 weeks following the completion of chemotherapy. In a predefined subgroup of 305 patients who were enrolled within 12 weeks of completing chemotherapy, Lucanix led to a median OS of 20.7 months vs. 13.4 months for placebo (p=0.083). Data will be presented at the European Cancer Congress in Amsterdam on Sept. 28. ...