Amgen Phase 3 Trial of Neulasta in Patients with Colorectal Cancer Met Primary Endpoint

Amgen

announced today results from Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES), a Phase 3 trial which evaluated Neulasta® (pegfilgrastim) in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line treatment of locally-advanced or metastatic colorectal cancer. FOLFOX and FOLFIRI are two of the most commonly used chemotherapy regimens for colorectal cancer. The study met its primary endpoint, with Neulasta significantly reducing the incidence of febrile neutropenia. Febrile neutropenia is a low white blood cell count accompanied by a fever.1 In the study, the incidence of grade 3 or 4 febrile neutropenia in patients receiving Neulasta across the first four cycles of chemotherapy was 2.4 percent compared to 5.7 percent in the placebo group (OR=0.41, p=0.014). A similar incidence of grade 3 or higher adverse events was seen in both arms of the trial (28 percent placebo; 27 percent Neulasta). "This analysis showed that PAVES met its primary endpoint, with Neulasta significantly reducing the incidence of febrile neutropenia in patients with colorectal cancer," said Sean E. Harper, M.D., executive vice president of