THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) announced the 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 company said that 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.
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. A similar incidence of grade 3 or higher adverse events was seen in both arms of the trial (28 percent placebo; 27 percent Neulasta).
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