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Title: Phase 2 Trial of Avastin (Bevacizumab) and FOLFIRI Produce Clinical Benefit in Most Metastatic Colorectal Cancer Patients: Presented at ASCO-GI

"Phase 2 Trial of Avastin (Bevacizumab) and FOLFIRI Produce Clinical Benefit in Most Metastatic Colorectal Cancer Patients: Presented at ASCO-GI"

By Ed Susman SAN FRANCISCO, CA -- January 30, 2006 -- Preliminary results of a phase 2 study show that 19 of 20 patients with metastatic colorectal cancer experienced some clinical benefit after being treated with a combination of the standard FOLFIRI regimen (5-fluorouracil, leucovorin, irinotecan) plus bevacizumab (Avastin). "We are proceeding ahead with this phase 2 trial," said Paulo Hoff, MD, associate professor of gastrointestinal medical oncology, University of Texas MD Anderson Cancer Center, Houston, Texas. "We will eventually enroll 42 patients in the study." So far, he said, 21 patients have been enrolled, but he reported on 20 who have been in the trial long enough for evaluation. Of those 20 patients, 14 have achieved a partial response and 5 others had stable disease, he said in his poster presentation January 28[^th at the 42^nd Annual Meeting of the American Society of Clinical Oncology - Gastrointestinal Cancer Symposium (ASCO-GI).

Patients were given 5 mg/mg of bevacizumab -- a recombinant monoclonal antibody that targets the vascular endothelial growth factor receptor -- about 30 minutes to 1 hour before FOLFIRI administration.

The components of FOLFIRI are administered as follows: 5-fluorouracil (5-FU) in a 10-minute 400-mg/m² bolus, along with 400 mg/m² of leucovorin and irinotecan 180 mg/kg in a 90-minute infusion. After that 2400 mg/m² of 5-FU is administered over 48 minutes. This cycle is repeated every 2 weeks.

Ten cases of grade 3 neutropenia were observed, including 1 case of febrile neutropenia; 1 grade 3 anemia case was recorded. Other grade 3 toxicities included fatigue, hypertension, vomiting, venous thrombosis, noncardiac chest pain, abdominal cramping, and hemorrhoids. One grade 4 pulmonary embolism occurred, although that was an asymptomatic incidental finding that occurred at restaging.

Nine of the original group of patients remain in the study: 4 were restaging and left the study to undergo potential curative surgery; 2 others had other surgeries unrelated to cancer; 1 person withdrew consent due to logistics; 2 withdrew due to toxicity and 3 patients withdrew after disease progressed.

Median time to response in this study was 18 weeks, Dr. Hoff noted, which illustrates that later responses to the therapy do occur.

"These early results suggest that FOLFIRI plus bevacizumab is an excellent choice as a first-line treatment for metastatic colorectal cancer," he said.

The study is sponsored by Genentech, South San Francisco, California.

The symposium was cosponsored by the American Society for Therapeutic Radiology and Oncology, the American Gastroenterological Association, and the Society of Surgical Oncology.

[Presentation title: Preliminary Results from a Phase II Study of FOLFIRI Plus Bevacizumab (Avastin) as First-Line Treatment for Metastatic Colorectal Cancer. Abstract 252]

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