Avastin Achieves Impressive Rate of Curative Surgery in Patients With Advanced Colorectal Cancer

Barcelona, Spain (ots/PRNewswire) -

- Largest Series of Patients With Successful Surgery Reported in
Large, Prospective Clinical Trial

- Abstract no: 3020, Being Presented at ECCO in Room 115-116,
Starting at 12:15 on Monday 24th September 2007

- For non-US Media Only

New data from the large international First BEAT trial unveiled
today at the European Cancer Conference (ECCO) demonstrate that a
high number of patients treated with Avastin plus standard
chemotherapy for their colorectal cancer underwent complete surgical
removal of their metastatic lesions. Complete removal of metastatic
lesions was achieved in almost 80% of these patients, all of whom had
been considered inoperable prior to the start of treatment. This
outcome with Avastin is higher than has been previously seen in
trials with other biologics/chemotherapy combinations.

The First BEAT trial included 1,965 patients with advanced
colorectal cancer with primarily inoperable metastatic disease.
Patients received Avastin in combination with the commonly used
fluoropyrimidine based chemotherapy regimens(i) as first line
treatment and were assessed for their suitability for potentially
curative surgery during the course of the treatment.

"The complete resection of metastatic lesions is the only option
for cure in patients with metastatic colorectal cancer. Therefore
these results represent a major step forward for the patient," said
Dr Mondher Mahjoubi, Global Head Medical Affairs Oncology, Roche.
"The high rates of successful, curative surgery achieved with Avastin
plus standard chemotherapy are impressive, especially because First
BEAT is a trial looking at a general, real life patient population".

First BEAT results presented at ECCO demonstrated that 215 (11.5%)
of all patients included in the current data analysis (1,914) became
eligible for and underwent surgery with curative intent during the
course of treatment. Successful, complete removal of the metastatic
lesions (R0 resection) was achieved in 170 patients, an impressive
success rate of 79%. The best outcomes as expected were achieved in
the subgroup of patients with metastatic disease confined to the
liver only (n=704). In this subgroup, 102 (14.5%) patients underwent
surgical removal of their liver metastases in curative intent with
successful complete (R0) resection achieved in 81 patients.

No increase in wound-healing complications or bleeding incidents
was observed compared with historical controls underlining the
favourable safety profile of Avastin in this setting.

Colorectal cancer is the third most common cancer with
approximately one million new cases worldwide every year. It is
estimated that over 50% of people diagnosed with colorectal cancer
will die of the disease(1).

About First BEAT

First BEAT is an international phase IV trial which has enrolled
1965, community based patients from 41 countries worldwide. Patients
diagnosed with unresectable metastatic disease received Avastin in
combination with standard first line chemotherapy; the most common
regimens were FOLFOX, XELOX, FOLFIRI and Xeloda (capecitabine). The
dose of Avastin used was equivalent to 2.5 mg/kg/week (5 mg/kg every
2 weeks with 5-FU-based regimens and 7.5 mg/kg every 3 weeks with
capecitabine-based regimens).

First BEAT completed recruitment in February 2006. The primary
endpoint was safety,. General efficacy and surgery with curative
intent were preplanned secondary endpoints and data were collected in
a prospective fashion. Efficacy data from the BEAT trial are
continuing to be evaluated with further data presentations expected
at upcoming oncology conferences.

Additional information

- Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Roche Health Kiosk, Cancer:
http://www.health-kiosk.ch/start_krebs

References

(i) The chemotherapy regimens selected were at the treating
physician's discretion. The most commonly used were FOLFOX, XELOX,
FOLFIRI and Xeloda (capecitabine) which is a reflection of current
clinical practice.

(1) Boyle P, Langman JS. ABC of colorectal cancer. Epidemiology.
BMJ 2000; 321:805-8

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For more information please contact: Christine Mage-Hill,
F.Hoffmann-La Roche, Mobile: +41-79-788-8245 (on-site at ECCO),
christine.mage-hill@roche.com; Dominic Elliston, Galliard Healthcare,
Direct: +44-207-663-2266, delliston@galliardhealthcare.com


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