Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 100 mg/4 mL [25 mg/mL], 200 mg/8 mL [25 mg/mL]) |
| Drug Class | Vascular endothelial growth factor (VEGF) inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen
Latest News
Summary
- This summary is based on the review of five randomized controlled trial(s). [1-5]
- FOLFIRI plus Ziv-Aflibercept in Metastatic Colorectal Cancer: The combination did not meet the primary endpoint for progression-free survival, reporting a median of 4.9 months. The overall response rate was 8%, with a disease control rate of 62%.
- Sapanisertib and Ziv-Aflibercept in Advanced Solid Tumors: The disease control rate was 78%, comprised of 74% stable disease and 4% partial response, with notable responses in 39 out of 50 evaluable patients.
- Ziv-Aflibercept in Advanced Neuroendocrine Tumors: Achieved a median progression-free survival of 11.8 months and an overall survival of 36.4 months, with 1 partial response (5%) and 13 stable disease (68%).
- No safety information available for FOLFIRI (5-FU+leucovorin+irinotecan) plus Ziv-Aflibercept in Metastatic Colorectal Cancer.
- In the Sapanisertib and Ziv-Aflibercept study, the most frequent adverse events included hypertension, fatigue, anorexia, hypertriglyceridemia, diarrhea, nausea, mucositis, and serum lipase increase, with no grade 5 events reported.
- No information on population types or subgroups available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zaltrap (ziv-aflibercept) Prescribing Information. | 2023 | Sanofi-Aventis U.S. LLC., Bridgewater, NJ |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| A Phase II Study of FOLFIRI Plus Ziv-Aflibercept After Trifluridine/Tipiracil Plus Bevacizumab in Patients with Metastatic Colorectal Cancer: WJOG 11018G | 26Subjects F: 62% M: 38% | 2024 | Targeted Oncology |
| Phase I study of sapanisertib (CB-228/TAK-228/MLN0128) in combination with ziv-aflibercept in patients with advanced solid tumors | 55Subjects F: 73% M: 27% | 2024 | Cancer Medicine |
| Ziv-aflibercept plus pembrolizumab in patients with advanced melanoma resistant to anti-PD-1 treatment | 10Subjects F: 70% M: 30% | 2024 | Cancer Immunology |
| A Phase II Study of Ziv-Aflibercept in Patients With Advanced Extrapancreatic Neuroendocrine Tumors | 19Subjects F: 32% M: 68% | 2022 | Pancreas |
| Phase IB study of ziv-aflibercept plus pembrolizumab in patients with advanced solid tumors | 33Subjects F: 42% M: 58% | 2022 | Journal for Immunotherapy of Cancer |
Sex Distribution:
F:62%
M:38%
26Subjects
Year:
2024
Source:Targeted Oncology
Sex Distribution:
F:73%
M:27%
55Subjects
Year:
2024
Source:Cancer Medicine
Document Title
Sex Distribution:
F:70%
M:30%
10Subjects
Year:
2024
Source:Cancer Immunology
Document Title
Sex Distribution:
F:32%
M:68%
19Subjects
Year:
2022
Source:Pancreas
Document Title
Sex Distribution:
F:42%
M:58%
33Subjects
Year:
2022
Source:Journal for Immunotherapy of Cancer
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Rectal cancer, version 2.2022, NCCN clinical practice guidelines in oncology | 2022 | Journal of the National Comprehensive Cancer Network |
| Clinical management of metastatic colorectal cancer in the era of precision medicine | 2022 | CA: A Cancer Journal for Clinicians |
| Treatment of patients with late-stage colorectal cancer: ASCO resource-stratified guideline | 2020 | Journal of Clinical Oncology |