FDA Approves Necitumumab Combination for Metastatic Squamous NSCLC


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The FDA approved necitumumab (Portrazza) in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC). Necitumumab is not indicated for treatment of nonsquamous NSCLC.

Necitumumab is a recombinant human IgG1 monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR) and blocks the binding of EGFR to its ligands.

Approval was based on the results of an open-label, multicenter, multinational, randomized trial of necitumumab in combination with gemcitabine and cisplatin vs gemcitabine and cisplatin alone in patients with metastatic squamous NSCLC who had not received prior therapy for metastatic disease (n = 1,093). Patients received necitumumab at 800 mg by intravenous infusion on days 1 and 8, gemcitabine at 1,250 mg /m2 on days 1 and 8 plus cisplatin at 75 mg/m2 on day 1 of each 3-week cycle (n = 545) or gemcitabine/cisplatin alone (n = 548). 

Improved Survival Rates

Necitumumab combined with gemcitabine/cisplatin demonstrated a statistically significant improvement in overall and progression-free survival vs gemcitabine/cisplatin alone. Median overall survival was 11.5 months (95% confidence interval [CI] = 10.4–12.6) for patients assigned to necitumumab plus gemcitabine/cisplatin and 9.9 months (95% CI = 8.9–11.1) for those assigned to gemcitabine/cisplatin alone (hazard ratio [HR] = 0.84, 95% CI  = 0.74–0.96, P = .01). Median progression-free survival was 5.7 months for patients assigned to necitumumab plus gemcitabine/cisplatin and 5.5 months for those assigned to gemcitabine/cisplatin alone (HR = 0.85, 95% CI = 0.74–0.98, P = .02). 

Side Effects

The most common adverse reactions (all grades) observed in necitumumab-treated patients at a rate of at least 30% and at least 2% higher than the gemcitabine/cisplatin–alone arm were rash and hypomagnesemia. Serious and clinically significant adverse events included hypomagnesemia, venous and arterial thromboembolic events, dermatologic toxicities, infusion reactions, and increased toxicity and increased mortality in patients with nonsquamous NSCLC. ■

 


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