A	B	C
1	Main
2		Brand Name	ZALTRAP
3		Generic Name	afilbercept
4		Indication	Cancer
5		Mechanism	VEGF and PLGF binder.
6		Economics	WW collaboration with SNY who pays 100% of expenses. REGN repays 50% of dev costs paid by SNY out of VEGF trap profits.
7		Clinical Trials
8			Phase III HRPC n=1200 - Taxotere combination - 2009 data? "VENICE"?
9
10			Phase III mNSCLC 2L n=900 - Taxotere combination - 2010 data? "VITAL"?
11
12			Phase III mCRC 2L n=1200 - IFL combination - 2010 data? "VELOUR"?
13
14			Phase III mPC n=650 "VANILLA"? - terminated
15
16			Phase II malignant ascites
17			77.5% response rate, 80% rate of doubling in time to paracentesis in symptomatic malignant ascites.
18			Final data expected in 1H09 and may support approval - Birchenough.
19
20			Phase II GBM - AAN 2008, ASCO 2008
21			30% RR, 3% 6-month PFS vs 43% with Avastin. Lower PFS was a function of patient advancement.
22			32% RR update?
23
24			Phase II mOC - Failed
25			n=215 failed to demonstrate >5% RR with ORR of 4.6% to 0.9%.
26
27			Phase II trial of aflibercept (VEGF Trap) in previously treated patients with metastatic colorectal cancer (MCRC): A PMH phase II consortium trial.
28			Abstract: 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 < 2. Exclusion criteria: prior treatment with a VEGF or VEGFR inhibitor other than bevacizumab (BEV). IV VEGF Trap (4 mg/kg) was administered every 2 weeks (1 cycle). The primary endpoint was RR and 4-month PFS. Pts were enrolled in two cohorts: BEV naïve and prior BEV. Planned sample size in each cohort was 40 pts. Results: In total, 51 pts were enrolled (BEV naive = 24 pts; prior BEV = 27; median age=59, range 39-80; M:F = 30:21; ECOG 0:1:2 = 21:27:3; median # prior regimens for MCRC = 2, range 1-6). After 287 cycles of therapy, most common treatment adverse events (TAEs) of any grade were (#pts): fatigue (40), hypertension (28), proteinuria (25), headache (22), voice alteration (16), anorexia (12), and joint pain (9). Grade 3+ TAEs in > 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.