FALCON is a randomized controlled study investigating the addition of ZYBRESTAT (fosbretabulin tromethamine, or CA4P) to standard therapy (carboplatin, paclitaxel, and bevacizumab) in patients with Stage IIIb or IV non-squamous NSCLC. A total of 60 patients were treated with study medication, including 29 in the standard therapy arm and 31 in the CA4P + standard therapy arm. The treatment arms were well balanced with respect to baseline characteristics, except for a greater percentage of males in the CA4P arm. Disease was predominately Stage IV in both arms. Patients received CA4P plus standard therapy or standard therapy alone every 21 days for up to 6 cycles (treatment phase). Patients without disease progression after 6 cycles could continue to receive bevacizumab with or without CA4P (depending on treatment arm) until disease progression (maintenance phase).
Key data points from the ongoing FALCON trial are as follows.
Progression-free survival (PFS)
•PFS determined by RECIST criteria •Median PFS was 9.5 months in the CA4P arm versus 8.8 months in the standard therapy arm (hazard ratio (95%CI) = 0.73 (0.33, 1.62)) •PFS represents a 27% reduction in the odds of progression for patients receiving CA4P vs. standard therapy Best Overall Tumor response
•Partial Response (PR) was 50% in the CA4P arm and 38% in the standard therapy arm A copy of the EORTC-NCI-AACR presentations will be available on OXiGENE's website at www.oxigene.com.