Phase II trial of aflibercept (VEGF Trap) in previously treated patients with metastatic colorectal cancer (MCRC): A PMH phase II consortium trial

4027 Background: Vascular endothelial growth factor (VEGF) is an important target in MCRC. Aflibercept (VEGF Trap) is a recombinant fusion protein of the human VEGFR1 and R2 extracellular domains and the Fc portion of human IgG1. Methods: This is an open-label, multi-centre, 2-stage phase II trial in pts with MCRC. Eligibility criteria: >1 prior systemic therapy for MCRC, ECOG 1 pt were (#pts): hypertension (4), proteinuria (4), fatigue (3), headache (3). One pt died on treatment due to PD. In the BEV naïve cohort (n=24), 4 pts were inevaluable: 7 pts maintained 4-mo PFS, disease control rate (PR + SD > 16 wks) = 29% 95% CI 13–51%, and median PFS was 2.0 mo 95% CI 1.7- not reached (NR). In the prior BEV cohort (n=27), 1 pt was inevaluable. There was 1 confirmed PR and 7 pts maintained 4-mo PFS, disease control rate 30% 95% CI 14–50%, and median PFS was 3.4 mo 95% CI 1.9-NR. Conclusions: Aflibercept (VEGF Trap) is well tolerated in pretreated pts with MCRC. Single agent activity has been observed in the prior BEV cohort, and accrual is ongoing in this stratum. Based on the study results, studies of aflibercept as single agent or in combination should be explored. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Johnson & Johnson, Pfizer Oncology