Phase III study of Neulasta (Amgen) for Neutropenia in Colorectal Cancer meets primary endpoint

PAVES, a Phase III trial evaluating Neulasta (pegfilgrastim), from Amgen, in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for first-line treatment of metastatic Colorectal Cancer, has met its primary endpoint, with Neulasta significantly reducing the incidence of febrile Neutropenia. All patients received treatment with either FOLFOX or FOLFIRI plus bevacizumab and were randomized to receive either placebo or 6 mg of Neulasta after each cycle of chemotherapy. The primary endpoint was the incidence of grade 3 or 4 febrile Neutropenia during the first four cycles.

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 (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). Full results will be presented at the 2013 Gastrointestinal Cancers Symposium. Follow-up results of PAVES looking at additional endpoints, including mature data on overall survival, overall response rate, time to progression and progression-free survival, will be presented at a future date.