Amgen, a biotechnology medicines company, has announced positive results from Pegfilgrastim and Anti-VEGF evaluation study, or PAVES, a Phase III trial which evaluated Neulasta, or 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. 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).
"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 R&D at Amgen. "In addition to providing new data on Neulasta, we believe PAVES will provide valuable information to the oncology community on commonly-used chemotherapy regimens."