Portrazza
Oncology· 103 cited findings· 1 source document
Company: Eli Lilly and Company →
What the regulatory reviews say
Portrazza (necitumumab) is a drug indicated for use in combination with gemcitabine and cisplatin for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). The efficacy of Portrazza was evaluated in a clinical trial with 1093 patients enrolled, randomized in a 1:1 ratio. Patients in the necitumumab arm (545 patients) demonstrated an overall survival of 11.5 months, compared to 9.9 months in the control arm, with an overall survival hazard ratio of 0.84 (p-value 0.01). Progression-free survival was 5.7 months for the necitumumab arm versus 5.5 months for the control arm, with a hazard ratio of 0.85 (p-value 0.02). The overall response rate for Portrazza was 31%.
Safety findings for Portrazza included a median duration of exposure to necitumumab of 4.6 months across 538 patients. Common adverse events included rash (44% incidence), vomiting (29% incidence), and diarrhea (16% incidence). Grade 3 or higher adverse events included venous thromboembolic events (5% incidence), rash (4% incidence), and vomiting (3% incidence). The treatment discontinuation rate due to adverse events was 12%. An Advisory Committee Meeting for Portrazza was held on July 9, 2015.
Key figures — cited to the source page
| Overall Survival (Portrazza arm) | 11.5 | Portrazza FDA Summary Review, p.3 |
| Overall Survival (Control arm) | 9.9 | Portrazza FDA Summary Review, p.3 |
| Overall Survival Hazard Ratio | 0.84 | Portrazza FDA Summary Review, p.3 |
| Progression-Free Survival (Portrazza arm) | 5.7 | Portrazza FDA Summary Review, p.3 |
| Progression-Free Survival (Control arm) | 5.5 | Portrazza FDA Summary Review, p.3 |
| Rash Incidence | 44 | Portrazza FDA Summary Review, p.16 |
| Grade 3+ Venous Thromboembolic Events | 5 | Portrazza FDA Summary Review, p.16 |
| Advisory Committee Meeting Date | July 9, 2015 | Portrazza FDA Summary Review, p.18 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.