Amgen's phase 3 trial of panitumumab shows positive results in colorectal cancer survival

By Lisa Kerner

Erie, Pa., April 3 - Amgen Inc. said results from its pivotal phase 3 trial show that panitumumab, a fully human monoclonal antibody, significantly improved progression-free survival and disease control compared to best supportive care (BSC) in metastatic colorectal cancer patients who had failed standard chemotherapy.

The results were presented at the 97th Annual Meeting of the American Association for Cancer Research, according to a news release.

"Panitumumab reduced the rate of disease progression by approximately half compared to best supportive care alone in these heavily pre-treated patients," said Marc Peeters, coordinator of the Digestive Oncology Unit, University Hospital Ghent, and one of the study's lead investigators, in the release.

"Furthermore, the difference in objective response rates and the proportion of patients with disease stabilization between panitumumab and best supportive care alone demonstrated the significant activity of this agent."

In this multinational, open-label phase 3 study, 463 patients with metastatic colorectal cancer who had failed standard chemotherapy, were randomized to receive 6 mg/kg panitumumab plus BSC every two weeks or BSC alone. A radiology review board assessed disease progression and tumor shrinkage, the company said.

Patients who received panitumumab every two weeks showed a 46% decrease in tumor progression rate versus those who received best supportive care alone.

The American Cancer Society estimates that about 106,680 new cases of colon cancer and 41,930 new cases of rectal cancer will be diagnosed in 2006.

Amgen, based in Thousand Oaks, Calif., discovers, develops and delivers human therapeutics.

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