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www.fdanews.com/articles/108169-roche-touts-avastin-against-k-ras-wild-type-colorectal-cancer

Roche Touts Avastin Against K-Ras, Wild-Type Colorectal Cancer

July 1, 2008

Roche and Genentech’s cancer agent Avastin is effective against colorectal cancer tumors that have both wild-type and mutated K-Ras genes, unlike other biologic therapies, according to data presented at a European oncology conference.

“This outcome is significant because other biologic combinations have been found to be ineffective in patients with a mutation in the K-Ras gene, which is found in up to half of patients with colorectal cancer,” Roche said Monday.

Vascular endothelial growth factor antibody Avastin (bevacizumab) was approved by the FDA in 2004 to treat advanced colorectal cancer. It is a first-line treatment.

Data presented at the 10th World Congress on Gastrointestinal Cancer in Barcelona, Spain, demonstrated “unprecedented efficacy” for Avastin when used in previously untreated patients with metastatic disease whose cancer had a normal or wild type K-Ras gene, with an 82 percent increase — from 7.4 months to 13.5 months — in progression-free survival compared with treatment by chemotherapy alone, Roche said.

The claims stem from analysis of tumor samples from 230 patients in the 800-patient AVF2107 trial, which was the basis of the product’s original colorectal cancer indication.

Patients with the wild type K-Ras gene had a 57 percent increase in survival — from 17.6 months to 27.7 months — compared with treatment by chemotherapy alone, Roche said. 

For patients who have tumors with a mutated K-Ras gene, a 69 percent increase in progression-free survival was found (from 5.5 months to 9.4 months) compared with those treated by chemotherapy alone.

“These results show that Avastin-based therapy is the only biologic option with proven benefits for patients with K-Ras mutation,” Roche said.