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Amgen Inc Announces Results From Phase 3 PAVES Study Evaluating Neulasta (pegfilgrastim) In Patients With Colorectal Cancer


Saturday, 26 Jan 2013 10:00am EST 

Amgen Inc announced 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% compared to 5.7% 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% placebo; 27% Neulasta). The trial was multicenter and multinational. All patients received treatment with either FOLFOX or FOLFIRI plus bevacizumab and were randomized to one of two treatment arms that also received either placebo or 6 mg of Neulasta at least 24 hours after each cycle of chemotherapy. The primary endpoint was the incidence of grade 3 or 4 febrile neutropenia during the first four cycles. The study was not designed to define the febrile neutropenia rate of FOLFOX or FOLFIRI plus bevacizumab. 

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