Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 800 mg/50 mL [16 mg/mL]) |
Drug Class | Epidermal growth factor receptor (EGFR) antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer.
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Summary
- Portrazza (necitumumab) is indicated in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non-small cell lung cancer.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Overall Survival (OS): Necitumumab combined with platinum-based chemotherapy (NC) did not show a significant OS advantage over chemotherapy alone (CA) (95% CI: 0.85-1.01, P=0.09), but a subanalysis indicated an OS advantage in patients with high epidermal growth factor receptor (EGFR) expression. Pooled analysis showed a significant OS improvement with NC in advanced NSCLC patients (HR=0.87, 95% CI 0.79-0.95, p=0.004).
- Progression-Free Survival (PFS): The NC group demonstrated longer PFS compared to the CA group (95% CI: 0.84-0.99, P=0.03), although pooled data indicated no statistically significant improvement in PFS (HR=0.83, 95% CI 0.69-1.01, p=0.06).
- Objective Response Rate (ORR) and Disease Control Rate (DCR): ORR was similar between the NC and CA groups (95% CI: 0.93-1.71, P=0.14), with no significant improvement noted in pooled analysis (OR=1.46, 95% CI 0.90-2.38, p=0.13). DCR was higher in the NC group (95% CI: 1.01-1.10, P=0.03).
- The addition of necitumumab to chemotherapy was associated with an increased risk of severe skin rash (OR=14.50, 95% CI 3.16-66.43, p=0.0006), hypomagnesemia (OR=2.77, 95% CI 2.23-3.45, p<0.00001), and venous thromboembolism compared to chemotherapy alone. The OR for any grade ≥3 adverse event was 1.55 (95% CI 1.28-1.87, p<0.00001).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Portrazza (necitumumab) Prescribing Information. | 2015 | Lilly USA, LLC., Indianapolis, IN |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Necitumumab plus platinum-based chemotherapy versus chemotherapy alone as first-line treatment for stage IV non-small cell lung cancer: a meta-analysis based on randomized controlled trials. | 2021 | Annals of Palliative Medicine |
Effects of adding necitumumab to first-line chemotherapy in patients with stage IV non-small-cell lung cancer: Meta-analysis. | 2020 | Journal of Oncology Pharmacy Practice |