Avastin and Xeloda meet primary endpoints in large Phase III first line metastatic colorectal cancer study

Roche announced today that a large, international Phase III study (NO16966) enrolling 2, 035 previously untreated metastatic colorectal patients met both primary endpoints.

Results of the study showed that:

• The chemotherapy combination Xeloda plus oxaliplatin, called XELOX is as effective in terms of progression-free survival (PFS) - a measure of the time patients live without their disease progressing - as infused 5-FU/leucovorin plus oxaliplatin, called FOLFOX;
• The addition of Avastin to chemotherapy (FOLFOX and XELOX) significantly improved progression-free survival compared to chemotherapy alone.

Some variability in treatment benefit was observed in subgroups. No new safety signals related to Avastin were observed in the trial.

"This is the first time that we have significant data showing that oral Xeloda in combination with oxaliplatin is as effective as FOLFOX, demonstrating that XELOX provides a new treatment option for colorectal cancer patients" said Ed Holdener, Head of Global Development at Roche. "These data again show the benefit of adding Avastin to chemotherapy. In this trial Avastin combined with FOLFOX and XELOX improved the chance of delaying progression of the disease by 20% in patients with metastatic colorectal cancer."

Results from the study will be submitted to a future international cancer congress.

In 2004, colorectal cancer was one of the leading cancers and accounted for 13 percent of all cancers.⁽¹⁾ It is estimated that more than 394,000 people die worldwide from colorectal cancer each year.⁽²⁾

References:

1. Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Annals of Oncology 2005; 16:481-488

2. Boyle P, Langman JS. ABC of colorectal cancer. Epidemiology. BMJ 2000; 321:805-808