Phase 3 Results Announced for Neulasta in Colorectal Cancer

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Amgen announced the results from a Phase 3 study, Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES) which evaluated Neulasta (pegfilgrastim) for the first-line treatment of locally-advanced or metastatic colorectal cancer.

PAVES is a multicenter, multinational, randomized, double-blind, placebo-controlled trial evaluating Neulasta in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line treatment of locally-advanced or metastatic colorectal cancer. All patients received either FOLFOX or FOLFIRI plus bevacizumab treatment and were randomized to one of two treatment arms that also received either placebo or 6mg of Neulasta at least 24hours after each cycle of chemotherapy. The primary endpoint was the incidence of grade 3 or 4 febrile neutropenia during the first four cycles.

The primary endpoints of the study were met with Neulasta significantly reducing the incidence of febrile neutropenia. The occurrence of grade 3 or 4 febrile neutropenia in patients receiving Neulasta across the first four cycles of chemotherapy was 2.4% vs. 5.7% in the placebo group (OR=0.41, p=0.014).

Neulasta is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

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