Capoxigem apricoxib: Phase II data

The double-blind, U.S. Phase II APRiCOT-L trial in 114 evaluable patients who previously failed a platinum-based chemotherapy regimen showed that once-daily 400 mg oral Capoxigem plus erlotinib missed the primary endpoint of significantly improving time to disease progression vs. placebo plus erlotinib (1.8 vs. 2.1 months, p=0.79). Capoxigem plus erlotinib also missed the secondary endpoints of significantly improving OS (7.4 vs. 6.4 months, p=0.78) and DCR (51% vs. 46%) vs. placebo plus erlotinib. There was also no significant difference between treatment groups in response rates (12% vs. 13%). 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%) and thus 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.

A pre-specified subgroup analysis of patients <=65 years of age (n=65) showed that Capoxigem plus erlotinib did significantly improve time to disease progression vs. placebo plus erlotiinib (2.7 vs. 1.4 months, p=0.018). The combination also significantly improved OS (12.2 vs. 4 months, p=0.021), DCR (60% vs. 35%, p=0.018) and response rates (18% vs. 5%, p=0.036) vs. placebo plus erlotinib in the subgroup. The most common adverse events were diarrhea, rash, fatigue and nausea. The trial enrolled patients with stage IIIB or IV NSCLC who had a >=50% reduction from baseline in urinary PGEM, a biomarker for tumoral COX-2 activity, following a 5-day, open-label run-in period with Capoxigem. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...