Table 1.
Completed Phase II and III trials of ziv-aflibercept in metastatic colorectal cancer
| Trial | Patient population | Treatments | Results |
|---|---|---|---|
| Phase II | |||
| PMH Phase II Consortium64 (NCT00407654) |
Previously treated mCRC 1+ prior lines of therapy (n=74) | Single-agent ziv-aflibercept | Bevacizumab-naïve: RR: 0% (0 PR, 5 SD at 16 weeks) mPFS: 2.0 months (95% CI 1.7–8.6) mOS: 10.4 months (95% CI 7.6–15.5) |
| Two cohorts: bevacizumab-naïve (n=24) prior-bevacizumab (n=50) | Prior-bevacizumab: RR: 2.0% (1 PR, 6 SD at 16 weeks) mPFS: 2.4 months (95% CI 1.9–3.7) mOS: 10.4 months (95% CI 6.2–10.6) |
||
| AFFIRM67 (NCT00851084) | Treatment-naïve mCRC no prior systemic treatment (n=236) | mFOLFOX6 + ziv-aflibercept (n=119)‡ | RR: 49.1% (95% CI 39.7–58.6%) PFS12: 25.8% (95% CI 17.2–34.4%) mPFS: 8.48 months (95% CI 7.89–9.92) |
| mFOLFOX6 (n=117)‡ | RR: 45.9% (95% CI 36.4–55.7%) PFS12: 21.2% (95% CI 12.2–30.3%) mPFS: 8.77 months (95% CI 7.62–9.27) |
||
| Phase III | |||
| VELOUR68 (NCT00561470) | Previously treated mCRC progression on or ≤6 months after prior oxaliplatin-containing regimen (n=1,226) | FOLFIRI + ziv-aflibercept (n=612) versus FOLFIRI + placebo (n=614) | RR: 19.8% versus 11.1% (P<0.001) mPFS: 6.90 versus 4.67 months (HR 0.758; P<0.0001) mOS: 13.50 versus 12.06 months (HR 0.817; P=0.0032) |
Note:
‡
Study was non-comparative, not powered to compare two treatment arms.
Abbreviations: CI, confidence interval; FOLFIRI, 5-fluorouracil, leucovorin, and irinotecan; mCRC, metastatic colorectal cancer; HR, hazard ratio; metastatic colorectal cancer; mFOLFOX6, modified 5-fluorouracil, leucovorin, and oxaliplatin; mOS, median overall survivial; mPFS, median progression-free survival; NCT, National Clinical Trials; PFS12, progression-free survival at 12 months; PMH, Princess Margaret Hospital; PR, partial response; RR, response rate; SD, stable disease.