Amgen has reported positive results from its Phase III pegfilgrastim and anti-VEGF evaluation study (PAVES) evaluating Neulasta (pegfilgrastim) in patients with colorectal cancer.
The Phase III trial, conducted in 845 patients receiving Folfox or Folfiri and bevacizumab for first-line treatment of locally-advanced or metastatic colorectal cancer, met its primary endpoint.
The randomised, double-blind study identified a significant reduction of febrile neutropenia incidence, a low white blood cell count accompanied by a fever.
Amgen research and development executive vice president Dr Sean Harper said PAVES met its primary endpoint as Neulasta significantly reduced the incidence of febrile neutropenia in patients with colorectal cancer.
“In addition to providing new data on Neulasta, we believe PAVES will provide valuable information to the oncology community on commonly-used chemotherapy regimens,” Harper said.
The incidence of grade 3 or 4 febrile neutropenia observed in the placebo-controlled study in Neulasta-administered patients across the first four cycles of chemotherapy was 2.4%, compared to 5.7% in the placebo group.
According to the study data, a similar incidence of grade 3 or higher adverse events was seen in both arms of the trial.
Further research is going on to assess other endpoints of the multicentre study conducted in various countries, including overall response rate, progression-free survival, overall survival, time to progression and adverse events.
