Amgen Phase 3 pegfilgrastim and anti-VEGF evaluation study meets primary endpoint

In the double-blind study, 845 patients were administered with Folfox or Folfiri and bevacizumab as the front-line treatment of locally-advanced or metastatic colorectal cancer.

Neulasta demonstrated the significant reduction of febrile neutropenia incidence, a low white blood cell count accompanied by fever.

Amgen research and development executive vice president 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 added.

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 observed in both arms of the trial.

Other endpoints such as overall response rate, progression-free survival, overall survival, time to progression and adverse events are to be assessed.