GDC-0449: Phase II data
Top-line data from a double-blind, U.S. Phase II trial in 195 previously untreated mCRC patients showed that 150 mg/day oral GDC-0449 plus Avastin bevacizumab and either FOLFOX or FOLFIRI chemotherapy missed the primary endpoint of significantly improving PFS vs. placebo plus Avastin and either FOLFOX or FOLFIRI chemotherapy. Interim safety data presented at the American Society of Clinical Oncology meeting in Chicago earlier this month showed that GDC-0449 displayed a safety profile that was consistent with that of Avastin and FOLFOX or FOLFIRI standard of care treatment.
Roche has exclusive ex-U.S. rights to GDC-0449 from its Genentech unit, which is co-developing the product with Curis under a 2003 deal (see BioCentury, June 16, 2003). Chugai, which is majority-owned by Roche, licensed exclusive Japanese rights to the compound in February (see BioCentury, Feb. 22). ...