Zaltrap(aflibercept)

Zaltrap (aflibercept) is indicated for use in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy in the treatment of adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen. The Marketing Authorisation for Zaltrap was recommended, and it has also been given in the USA. The pivotal trial was a single randomised, double-blind controlled trial.

In terms of efficacy, Zaltrap demonstrated a median overall survival of 13.5 months, compared to 12.1 months in the control arm, representing a survival advantage of 1.44 months. The Hazard Ratio for overall survival was 0.817 (95% CI: 0.713 to 0.937; p-value: 0.0032), indicating an 18% reduction in the risk of death. The objective response rate in the aflibercept arm was 19.8%, compared to 11.1% in the placebo arm. Median progression-free survival was 2.23 months.

Safety data from an integrated database (2073 patients on aflibercept, 1354 on placebo) showed that 26.8% of patients in the aflibercept arm experienced permanent treatment discontinuation due to adverse events, compared to 12.1% in the placebo arm. Grade 3-4 treatment-emergent adverse events (TEAEs) occurred in 83.5% of the aflibercept arm versus 62.5% in the placebo arm. Serious TEAEs were reported in 48.1% of the aflibercept arm compared to 32.7% in the placebo arm. Deaths from adverse events occurred in 2.3% of the aflibercept arm and 0.7% of the placebo arm.