First positive phase III results with an anti-angiogenic therapy for cancer

Phase III trial of Avastin plus chemotherapy markedly extends survival of metastatic colorectal cancer patients

20-May-2003

Genentech, Inc. (NYSE: DNA) today announced that a Phase III study of Avastin(TM) (bevacizumab, rhuMAb-VEGF) plus chemotherapy in previously-untreated metastatic colorectal cancer patients met its primary endpoint of improving overall survival. The magnitude of the benefit observed far exceeded what the study was designed to demonstrate. The trial also met the secondary endpoints of progression-free survival, response rate, and duration of response. Genentech plans to submit data from this Phase III metastatic colorectal cancer trial to the annual meeting of the American Society of Clinical oncology (ASCO), May 31 - June 3.

Avastin is an investigational therapeutic antibody designed to inhibit Vascular Endothelial Growth Factor (VEGF), a protein that plays a critical role in tumor angiogenesis (the formation of new blood vessels to the tumor) and maintenance of existing tumor blood vessels. By inhibiting VEGF, Avastin is designed to interfere with processes that are critical to tumor growth and metastasis.

"The data from this important Phase III trial, which show that treatment with Avastin and chemotherapy resulted in improved survival, highlights a potentially new way to treat patients with metastatic colorectal cancer," said Susan D. Hellmann, M.D., M.P.H., Genentech's executive vice president, Development and Product Operations, and chief medical officer. "These data strongly suggest that inhibiting VEGF - a growth factor first cloned by Genentech scientists - results in clinical benefit for colorectal cancer patients and has the potential to change the practice of treating cancer."

"This study also provides the first Phase III clinical validation of the long-pursued 'anti-angiogenic' hypothesis - that by targeting a tumor's blood supply, you may impact its viability. Based on the strength of these data, Genentech plans to discuss the filing of a Biologics License Application with the U.S. Food and Drug Administration," continued Dr. Hellmann.

This multi-center study enrolled more than 900 patients, and randomized 800 patients to receive either Avastin plus the standard of care chemotherapy (5-FU/Leucovorin/CPT-11, called the Saltz regimen) or the Saltz regimen plus an Avastin placebo. A third arm of the study treated 100 patients with Avastin plus 5-FU/ Leucovorin chemotherapy. This arm was dropped, as pre-specified, once safety with the Saltz regimen was established.

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