Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 100 mg/5 mL, 400 mg/20 mL [20 mg/mL] in a single-dose vial) |
Drug Class | Epidermal growth factor receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC): in combination with FOLFOX for first-line treatment.
- Indicated as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
Latest News
Summary
- Vectibix (panitumumab) is indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC): in combination with FOLFOX for first-line treatment; and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- The combination of FOLFOXIRI and anti-EGFR antibodies demonstrated a higher Objective Response Rate (ORR) of 85% (95% CI, 0.78-0.91) and a higher R0 resection rate (R0RR) of 42% (95% CI, 0.32-0.53) compared to FOLFOXIRI alone. Pooled ORR in the meta-analysis was 82% (95% CI, 76-88%), with an R0RR of 59% (95% CI, 49-68%) for colorectal liver metastasis (CLM).
- Panitumumab supplementation improved ORR in patients with wild-type (WT) KRAS (RR = 1.70; 95% CI = 1.07–2.69) but did not significantly affect ORR in mutant KRAS patients (RR = 0.92; 95% CI = 0.79–1.08). The treatment did not notably impact progression-free survival (PFS) or overall survival (OS) in WT KRAS patients (PFS: RR = 0.94; 95% CI = 0.85–1.02, OS: RR = 0.86; 95% CI = 0.69–1.08).
- The median PFS in the studies ranged from 9.5 to 17.8 months, with the pooled median PFS being 11.7 months. The median OS ranged from 24.7 to 62.5 months, with a pooled median OS of 31.9 months.
- Common grade 3 and 4 adverse events associated with panitumumab supplementation include diarrhea (29%), neutropenia (28%), and skin toxicity (17%), with an overall increased incidence of these adverse events compared to control groups (RR = 1.17; 95% CI = 1.08–1.27).
- The meta-analysis did not show a significantly increased risk of fatal adverse events (FAEs) for panitumumab, regardless of its use as first-line, second/further line, or adjuvant treatment compared to placebo or blank treatment.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Vectibix (panitumumab) Prescribing Information. | 2021 | Amgen Inc. Thousand Oaks, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
The five-year KRAS, NRAS and BRAF analysis results and treatment patterns in daily clinical practice in Slovenia in 1st line treatment of metastatic colorectal (mCRC) patients with RAS wild-type tumour (wtRAS) – a real-life data report 2013-2018. | 2023 | Radiology and Oncology |
Tumor biomarker testing for metastatic colorectal cancer: a Canadian consensus practice guideline. | 2022 | Therapeutic Advances in Medical Oncology |