Investor Update
Basel, 2 July 2007
Avastin
shows impressive results for surgery with curative intent in initially unresectable first-line metastatic
colorectal cancer patients
Large clinical trials investigating
the use of Avastin in combination with various chemotherapy regimens in 1st line metastatic colorectal
cancer reported impressive results for surgery with curative intent in patients whose metastatic lesions
were assessed inoperable upon diagnosis. The data presented at the 9th World Congress on Gastrointestinal
Cancer (WCGC) in Barcelona clearly demonstrate that secondary resection of metastatic disease with curative
intent can be successfully achieved in a safe, well tolerated and efficacious manner with Avastin as
the backbone treatment.
In the large, prospective international phase
IV trial BEAT, which enrolled more than 1900 patients with inoperable metastatic colorectal cancer,
impressive rates of surgery with curative intent were shown:
- Overall,
180 surgeries with curative intent (9.4%) were performed. This number compares favourably with historical
data and is even more impressive as the patients included in the trial did not belong to a selected
subgroup (e.g. EGFR +). The BEAT study population was unselected and reflected a standard
global patient pool.
- Of interest is the number
of surgeries with
curative intent in the group of patients that were treated with Avastin in combination with the most
widely used regimens FOLFOX and FOLFIRI:
- In a group of 547 and 504 patients, respectively, the achieved percentage of surgeries with curative intent reached 15.4 % for Avastin + FOLFOX and 7.4% for Avastin + FOLFIRI.
- In the subgroup of patients with metastatic lesions exclusively located in the liver the percentage increased to 26.6% for Avastin with FOLFOX and 14.2% for Avastin with FOLFIRI.
In the large, international, phase III
trial NO16966, which enrolled 1400 patients in the placebo-controlled part of the study, the total number
of surgeries with curative intent reached 8.4% in the group treated with Avastin + oxaliplatin-based
chemotherapy. The reported data for those patients with liver metastasis only (around 25% of the total
study population) were even more promising. The study showed that 19.2% of patients receiving Avastin
in this subgroup underwent liver surgery with curative intent compared to 12.9% in the control group.
In both trials the number of observed bleeding or wound-healing incidents
following surgery did not increase, thereby demonstrating again the excellent tolerability and safety
of Avastin. The safety and effectiveness of Avastin use in colorectal cancer patients with potentially
resectable metastatic disease was demonstrated previously in a phase II trial (B. Gruenberger et al.,
abstract 4060, ASCO 2007).
All data were collected prospectively
and surgery with curative intent was a preplanned assessment parameter in BEAT and NO16966.
These
data provide further strong clinical evidence that Avastin is the biological agent of reference that
leads not only to a significant and clinically meaningful progression-free and overall survival benefit
but also to potentially curative resectability in patients with metastatic colorectal cancer.
Background
on secondary resection of metastatic lesions
The concept of secondary resection
of metastatic lesions is currently getting attention in a disease setting formerly seen as strictly
palliative. While a small percentage of patients achieve secondary resection of metastatic lesions,
the potential for cure remains limited and requires further investigation. Even though recurrence
rates in resected patients are very high (80% of patients relapse within the first two years after surgery),
this approach offers an increase of time without disease recurrence.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s
biggest biotech company and an innovator of products and services for the early detection, prevention,
diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s
health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and
transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune
diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals
Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion
Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances
with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information
about the Roche Group is available on the Internet at www.roche.com.
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- Avastin: www.avastin-info.com