Public Release: 

A milestone in colorectal cancer unveiled - Avastin(TM) confers unprecedented survival advantage

First clinical validation of anti-angiogenic approach to cancer control

Resolute Communications

Copenhagen, Denmark, 21 September 2003 -Treatment with Avastin (bevacizumab, rhuMAb-VEGF) - a new agent designed specifically to restrict the blood supply to tumours - can significantly improve survival in advanced colorectal cancer compared to established chemotherapy alone, according to data presented today at the European Cancer Conference (ECCO). This represents the first, long-hoped for clinical evidence that anti-angiogenic therapy has a significant role to play in cancer treatment.

These results, from a 900-patient randomised Phase III study, showed that Avastin increased survival duration by over 30% when combined with first-line chemotherapy (IFL1) for advanced (metastatic) colorectal cancer.2

"For several years now, we have been investigating ways of blocking the blood supply to tumours through restricting a protein called Vascular Endothelial Growth Factor (VEGF)", explained lead investigator Dr Herbert Hurwitz, M.D., Duke University Medical Center, USA. "By inhibiting VEGF, bevacizumab selectively inhibits tumour growth by starving tumours of needed nutrients and other growth signals."

In addition to the 30% survival rate, the study found that when Avastin was added to IFL, patient survival time was extended from 15.6 months with chemotherapy alone to 20.3 months. The time to disease progression, response rate and duration of response were also all improved by Avastin. Importantly these clinical benefits were seen across all relevant patient subgroups in the population.

(IFL - Irinotecan + 5-fluorouracil + Leucovorin)
2 Am Soc Clin Oncol 2003;22 (Abstract 3646)

"The results of this important study clearly demonstrate that blocking the blood supply to tumours has real potential to help the majority of patients to a degree that is highly clinically relevant. For some patients the results are truly remarkable. This study has helped bring anti-angiogenesis therapy out of the laboratory and into the clinical world," concluded Dr Hurwitz.

The combination of Avastin and chemotherapy was well tolerated, with only grade 3 hypertension (> 180mmHg / > 110mmHg, which was manageable using standard oral medication) clearly more frequent in the Avastin-containing arm of the trial.

The impressive clinical results with Avastin in this study are underpinned by many years of research into the concept that tumours depend on a good blood supply for both growth and spread. Vascular endothelial growth factor, a protein that is inhibited by Avastin, plays a critical role in tumour angiogenesis (the formation of new blood vessels to tumours). Avastin is also under investigation in other forms of metastatic cancer, including non-small cell lung cancer, pancreatic and renal cell carcinoma.

Colorectal cancer is the third most common cancer in men and women, representing 10-15 percent of all cancers. In 2000, the World Health Organisation reported that almost 950,000 people worldwide were diagnosed with colorectal cancer and half of the patients died. In Europe, almost 365,000 patients are newly diagnosed with colorectal cancer each year. An application for approval of Avastin in treating colorectal cancer will be made to the European Union regulatory authorities in the coming months.

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For further information, contact:

Carrie Deverell
Roche Oncology
International Communications Manager
Tel 41-61-688-9848
Mobile 41-79-506-9940

Roche in Oncology
Within the last five years Roche has become the world's lead supplier of medicines for oncology. Its franchise includes Herceptin (breast cancer), MabThera (non-Hodgkin's lymphoma), Xeloda (colorectal cancer, breast cancer), NeoRecormon (anaemia in various cancer settings), Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma) and Kytril (chemotherapy and radiotherapy-induced nausea). Roche Oncology has four research sites (Germany, Japan and two in the US) and four HQ development sites (UK, Switzerland and two in the US) dedicated to oncology. Roche also offers a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests running on the LightCycler. Within its Integrated Cancer Care Unit the company develops new tests which will have a significant impact on disease management of cancer patients in the future.

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