Thursday, Jan 27, 2005


Preliminary Positive Results From Phase III Trial Of Avastin Plus
FOLFOX4 Chemotherapy Presented At ASCO GI Meeting


Hollywood, Fla. -- January 27, 2005 -- Genentech, Inc. (NYSE: DNA)
today announced that a randomized Phase III study (E3200) of Avastin™
(bevacizumab) plus the FOLFOX4 chemotherapy regimen (oxaliplatin/5-
FU/leucovorin), compared to FOLFOX4 alone in second-line metastatic
colorectal cancer patients achieved its primary endpoint of improving
overall survival. These data, first announced by the National Cancer
Institute (NCI) and Genentech in November 2004, were presented by
Bruce J. Giantonio, M.D., of the Abramson Cancer Center at the
University of Pennsylvania in Philadelphia at the Second Annual
Gastrointestinal Cancers Symposium. Avastin is currently approved as
a first-line treatment for metastatic colorectal cancer in
combination with intravenous 5-FU-based chemotherapy.
Results from a preliminary analysis of the E3200 study demonstrated
that patients receiving Avastin plus FOLFOX4 had a 26 percent
reduction in the risk of death (a hazard ratio of 0.74), the primary
endpoint, compared to patients who received FOLFOX4 alone. Median
survival for patients receiving Avastin plus FOLFOX4 was 12.5 months,
compared to 10.7 months for those receiving FOLFOX4 alone, a 17
percent improvement.

"Avastin is the only targeted therapy to demonstrate an improvement
in survival in first-line metastatic colorectal cancer patients, who
on average face a two-year life expectancy upon diagnosis. The data
presented today show that Avastin in combination with the FOLFOX4
regimen may be an effective treatment for second-line metastatic
colorectal cancer," said Gwen Fyfe, M.D., Genentech's vice president,
Clinical Hematology/Oncology. "The results from this study add to the
growing body of data showing that the addition of Avastin to 5-FU-
based chemotherapy regimens can result in meaningful clinical benefit
to patients with metastatic colorectal cancer, and we have initiated
discussions with the FDA to determine a filing strategy for the use
of Avastin plus FOLFOX in the second-line population."

Adverse events in this Phase III study were consistent with those
seen in previous Avastin and FOLFOX4 clinical trials in metastatic
colorectal cancer. The most frequent adverse events were hypertension
and sensory neuropathy, with six percent of patients (17/286) in the
Avastin plus FOLFOX4 arm experiencing Grade 3 or 4 hypertension
compared to two percent (5/282) in the FOLFOX4 arm. Grade 3 and 4
sensory neuropathy occurred at a rate of 15 percent (44/286) in the
Avastin plus FOLFOX4 arm, compared to a rate of nine percent (26/282)
in the FOLFOX4 arm. The most serious adverse events were bleeding,
which occurred at a rate of 2.8 percent (8/286) in the Avastin +
FOLFOX4 arm and less than one percent (1/282) in the FOLFOX4 arm,
gastrointestinal perforation, which occurred at a rate of one percent
(3/286) in the Avastin plus FOLFOX4 arm, and thrombosis, which
occurred in 4.5 percent of patients (13/286) treated with Avastin
plus FOLFOX4 and compared to 2.8 percent of patients (8/282) treated
with FOLFOX4.

About the E3200 Study
This Phase III study was a randomized, controlled, multicenter trial
that enrolled 829 patients with advanced colorectal cancer who had
previously received a 5-FU-based therapy and irinotecan, either alone
or concurrently, for advanced disease or if their disease had
relapsed within six months of concluding adjuvant treatment with
these chemotherapy agents. The patients enrolled in this trial were
randomized to receive treatment with the FOLFOX4 regimen with or
without Avastin. Randomization to a third arm of the study evaluating
single-agent Avastin was suspended in March 2003 on the
recommendation of the Data Monitoring Committee overseeing the study
when review of early results suggested that overall survival for
patients in that group might be lower compared to that of patients
treated in the other two arms. Results from this treatment arm have
not yet been disclosed.

The trial was sponsored by the National Cancer Institute (NCI), part
of the National Institutes of Health, and conducted by a network of
researchers led by the Eastern Cooperative Oncology Group (ECOG).
Genentech provided Avastin for the trial under the Cooperative
Research and Development Agreement (CRADA) with the NCI for the
clinical development of Avastin.

About Avastin
Avastin is a therapeutic antibody designed to inhibit Vascular
Endothelial Growth Factor (VEGF), a protein that plays an important
role in tumor angiogenesis and maintenance of existing tumor vessels.
By binding to VEGF, Avastin is designed to interfere with the blood
supply to tumors, a process that is critical to tumor growth and
metastasis. For full prescribing information, including Boxed
Warnings for Avastin and information about Avastin and angiogenesis,
visit www.gene.com or www.avastin.com.

The FDA approved Avastin on February 26, 2004 as a first-line
treatment for metastatic colorectal cancer in combination with
intravenous 5-FU-based chemotherapy. Approval was based on data from
two trials. The pivotal trial was a large, placebo-controlled,
randomized study of 925 patients that demonstrated a prolongation in
the median survival of patients treated with Avastin plus the IFL (5-
FU/leucovorin/CPT-11) chemotherapy regimen by approximately five
months, compared to patients treated with the IFL chemotherapy
regimen alone (20.3 months versus 15.6 months). In addition, this
study demonstrated an improvement in progression-free survival (PFS)
of more than four months (10.6 months in the Avastin/IFL arm compared
to 6.4 months in the IFL-alone arm). The survival and PFS results
observed when Avastin is added to first-line chemotherapy are the
longest ever reported in a randomized, Phase III study of patients
with metastatic colorectal cancer.

Last year the National Comprehensive Cancer Network (NCCN), an
alliance of 19 of the world's leading cancer centers, updated their
Colorectal Clinical Practice Guidelines and added Avastin in
combination with 5-Fluorouracil-based regimens -- including those
using oxaliplatin or irinotecan -- to its list of treatment options
for first-line advanced colon or rectal cancer.

Based on data showing that VEGF may play a broad role in a range of
cancers, Genentech is pursuing a late-stage clinical development
program with Avastin evaluating its potential use in adjuvant and
metastatic colorectal, renal cell (kidney), breast and non-small cell
lung cancers. Avastin is also being evaluated in earlier stage trials
as a potential therapy in prostate, ovarian, and several types of
solid tumor cancers and hematologic malignancies and melanoma.

Avastin Safety Profile
Avastin has a well-established safety profile. In Genentech-sponsored
studies, the most serious adverse events associated with Avastin were
infrequent, and included gastrointestinal perforation, wound healing
complications, hemorrhage, arterial thromboembolic events,
hypertensive crisis, nephrotic syndrome and congestive heart failure.
The most common Grade 3-4 adverse events (occurring in greater than
two percent of patients in the Avastin arm, compared to the control
group) were asthenia, pain, hypertension, diarrhea and leukopenia.
The most common adverse events (occurring in greater than two percent
of patients in the Avastin arm, compared to the control group) of any
severity were asthenia, pain, abdominal pain, headache, hypertension,
diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper
respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and
proteinuria.

About VEGF and Tumor Angiogenesis
The link between angiogenesis and cancer growth has been discussed by
many researchers for decades. It wasn't until 1989 that a key growth
factor influencing the process, VEGF, was discovered by Napoleone
Ferrara, M.D., a staff scientist at Genentech. Dr. Ferrara and his
team cloned VEGF, providing some of the first evidence that a
specific angiogenic growth factor existed. This research was
published in the journal Science in 1989. Dr. Ferrara then created a
mouse antibody to this protein. In 1993, Dr. Ferrara and his team at
Genentech, in a study published in Nature, demonstrated that the
antibody directed against VEGF could suppress angiogenesis and tumor
growth in preclinical models, providing compelling evidence that VEGF
can play a critical role in tumor growth. Clinical studies with a
humanized version of the antibody, Avastin, began in 1997.

About Genentech BioOncology
Genentech is committed to changing the way cancer is treated by
establishing a broad oncology portfolio of innovative, targeted
therapies with the goal of improving patients' lives. The company is
the leading provider of anti-tumor therapeutics in the United States.
Genentech is leading clinical development programs for Rituxan®
(Rituximab), Herceptin® (Trastuzumab), Avastin™ (bevacizumab) and
Tarceva™ (erlotinib), and markets all four products in the United
States alone (Avastin and Herceptin), with Biogen Idec Inc. (Rituxan)
or with OSI Pharmaceuticals (Tarceva). Genentech has licensed
Rituxan, Herceptin, and Avastin, and OSI Pharmaceuticals has licensed
Tarceva to Roche for sale by the Roche Group outside of the United
States.

The company has a robust pipeline of potential oncology therapies
with a focus on four key areas: angiogenesis, apoptosis (i.e.
programmed cell death), the HER pathway and B-cell biology. Potential
oncology therapies directed at the HER pathway include a therapeutic
antibody currently in Phase II trials. Also in early development are
a small molecule directed at the hedgehog pathway, a soluble human
protein targeting apoptosis and a humanized anti-CD20 antibody for
hematology/oncology indications.

Genentech is a leading biotechnology company that discovers,
develops, manufactures, and commercializes biotherapeutics for
significant unmet medical needs. A considerable number of the
currently approved biotechnology products originated from, or are
based on, Genentech science. Genentech manufactures and
commercializes multiple biotechnology products directly in the United
States, and receives royalties or other income from companies that
are licensed to market its products outside of the United States. The
company has headquarters in South San Francisco, Calif., and is
traded on the New York Stock Exchange under the symbol DNA. For
additional information about the company, please visit
http://www.gene.com.


# # #
For full prescribing information, including Boxed Warnings for
Avastin, please call 1-800-821-8590 or visit www.gene.com.