Ziv-aflibercept

(Zaltrap®)

Zaltrap®

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 100 mg/4 mL [25 mg/mL], 200 mg/8 mL [25 mg/mL])
Drug ClassVascular endothelial growth factor inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for use in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) for the treatment of metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin regimen.

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Summary
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  • Zaltrap (ziv-aflibercept) is indicated for use in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) for the treatment of metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin regimen.
  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • The pooled prevalence for 12-month Progression-Free Survival (PFS) with aflibercept was 18% (95% CI, 5%-37%) and for 12-month Overall Survival (OS) was 61% (95% CI, 53%-68%) when combined with FOLFIRI.
  • Pooled estimate rates for aflibercept in metastatic colorectal cancer (mCRC) included 16.0% for 12-month PFS, 64.4% for 12-month OS, 32.5% for Overall Response Rate (ORR), and 83.5% for Disease Control Rate (DCR).
  • Regorafenib demonstrated superior PFS compared to aflibercept in a comparative analysis, with a hazard ratio (HR) of 0.9631 (95% CI, 0.6785-1.367).
  • The incidence of antiangiogenic-related adverse events with aflibercept included hypertension (44.2%), proteinuria (31.3%), epistaxis (27.3%), hemorrhage events (22.5%), venous thromboembolic events (8.0%), with Grade III/IV hypertension and proteinuria occurring in 22.6% and 7.4% of cases, respectively.
  • Pooled prevalences of grade 3-4 toxicities associated with aflibercept included any grade 3-4 toxicities (69%), diarrhea (10%-16.8%), hypertension (13%-22.3%), neutropenia (29.5%-31%), venous thromboembolic event (5%), proteinuria (7.3%), and oral mucositis (8.6%), indicating significant safety concerns.
  • Subgroup analysis revealed no significant differences in primary endpoints when stratified by treatment line (first-line or non-first-line), chemotherapy regime (FOLFIRI or others), or study design (RCTs or single-arm trials). KRAS and BRAF mutated mCRC were identified as subgroups where regorafenib combined with chemotherapy might be a potential alternative to conventional options.

Product Monograph / Prescribing Information

Document TitleYearSource
Zaltrap (ziv-aflibercept) Prescribing Information.2020Sanofi-Aventis U.S. LLC, Bridgewater, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines