BioCentury
ARTICLE | Clinical News

Tragara reports Capoxigem data

June 7, 2011 12:20 AM UTC

Tragara Pharmaceuticals Inc. (San Diego, Calif.) said Capoxigem apricoxib plus erlotinib missed the primary endpoint of significantly improving time to disease progression vs. placebo plus erlotinib in the Phase II APRiCOT-L trial to treat non-small cell lung cancer (1.8 vs. 2.1 months, p=0.79). Tragara said there was an imbalance in the proportion of patients who discontinued the trial in the overall population for the Capoxigem group compared to placebo (21% vs. 7%), which affected the results for the active treatment arm. The company also said that most of the discontinuations in the active treatment arm were in older patients. The trial included 114 evaluable patients who previously failed a platinum-based chemotherapy regimen.

A pre-specified subgroup analysis of patients ages less than 65 (n=65) showed that Capoxigem plus erlotinib did significantly improve time to disease progression vs. placebo plus erlotinib (2.7 vs. 1.4 months, p=0.018). The combination also significantly improved overall survival (12.2 vs. 4 months, p=0.021) vs. placebo plus erlotinib in the subgroup. ...