Avastin Shows Encouraging Results in Phase II Study in Patients With the Most Aggressive Form of Brain Cancer
DALLAS -November 18, 2007 -- Genentech, Inc. (NYSE: DNA)
today announced that both study arms of a randomized, multi-center
Phase II clinical study of Avastin® (bevacizumab) administered
alone or in combination with irinotecan chemotherapy demonstrated
encouraging six-month progression-free survival (PFS) and objective
response rate in patients with relapsed glioblastoma multiforme
(GBM), the most common and aggressive type of brain cancer. As
assessed by independent radiological review, 36 percent (31/85) of
GBM patients treated with Avastin alone, and 51 percent (42/82) of
patients treated with Avastin in combination with chemotherapy,
lived without the disease advancing within six months. No new or
unexpected safety events related to Avastin have been observed in
the study. The data were presented at the 12th Annual Scientific
Meeting of the Society for Neuro-Oncology.
"Historical estimates suggest that only 15 percent of patients with
this aggressive type of brain cancer live without their cancer
progressing within six months," said Timothy Cloughesy, M.D.,
director, Neuro-Oncology Program of the Jonsson Comprehensive
Cancer Center at the University of California, Los Angeles and lead
investigator for the study. "The findings suggested that at six
months, more patients had lived without their cancer advancing when
Avastin was administered as a single-agent or in combination with
chemotherapy, than what we would normally expect."
"These findings exceeded our expectations, and due to the high unmet medical need of patients with relapsed GBM we plan to discuss these data with the FDA to determine next steps," said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer.
According to the American Cancer Society (ACS), the five-year survival rate for patients with GBM is 3 percent, and has not changed in more than 25 years. The ACS estimates there will be 20,500 new cases of brain cancer and 12,740 brain cancer deaths in 2007.
Study Results
In addition to six-month PFS rates of 36 and 51 percent
respectively in the Avastin-alone and Avastin plus chemotherapy
arms, preliminary estimates of tumor response were observed in 21
percent (18/85) of patients treated with Avastin alone and in 34
percent (28/82) of patients treated with Avastin in combination
with chemotherapy.
Adverse events related to Avastin in this trial appeared to be similar to those previously reported in other studies of Avastin. The most common severe (Grade 3 or greater) toxicities in the Avastin alone arm were hypertension (8 percent, 7/84) and convulsion (6 percent, 5/84). The most common severe adverse events in the Avastin plus chemotherapy arm were convulsion (13 percent, 10/79) and neutropenia (9 percent, 7/79). Grade 1 and 3 intracranial hemorrhage occurred in two patients in the Avastin alone arm, and one patient in the Avastin plus chemotherapy arm experienced a Grade 4 intracranial hemorrhage. There were two deaths associated with adverse events in the Avastin alone arm and one death associated with an adverse event in the Avastin plus chemotherapy arm.
Study Design
The study was a Phase II, open-label, multicenter, randomized,
non-comparative study that enrolled 167 patients with GBM whose
cancer had relapsed after first- or second-line therapy. All
patients had received prior temozolimide. Patients were randomized
to receive Avastin alone or in combination with irinotecan every
other week for up to 104 weeks. The primary endpoints were
six-month PFS and objective response rate as determined by an
Independent Radiology Facility (IRF). PFS was defined as the
absence of any event of cancer progression or death. Secondary
endpoints of the study included overall survival and safety. The
study is ongoing and final analyses for safety and other efficacy
endpoints will be available in 2008.
About Avastin
Avastin is a therapeutic antibody designed to specifically inhibit
vascular endothelial growth factor (VEGF), a protein that plays an
important role in angiogenesis and the maintenance of existing
blood vessels throughout the lifecycle of a tumor. By inhibiting
VEGF, Avastin is designed to interfere with the blood supply to a
tumor, which is thought to be critical to a tumor's ability to grow
and spread in the body (metastasize). For more information on
angiogenesis, visit http://www.gene.com. For full
prescribing information and Boxed Warnings on Avastin, visit
http://www.avastin.com.
The FDA first approved Avastin on February 26, 2004, as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. Avastin is also indicated in combination with intravenous 5-FU-based chemotherapy for second-line treatment of patients with metastatic carcinoma of the colon or rectum. On October 11, 2006, the FDA approved Avastin in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer. Avastin is being studied worldwide in more than 300 clinical trials in 20 different tumor types.
Avastin Safety
Avastin has a well-characterized safety profile in its approved
indications. The most serious adverse events associated with
Avastin across all trials were GI perforation, wound healing
complications, hemorrhage, non-GI fistula formation, arterial
thromboembolic events, hypertensive crisis, reversible posterior
leukoencephalopathy syndrome (RPLS), neutropenia and infection,
nephrotic syndrome and congestive heart failure. The most common
adverse events in patients receiving Avastin were asthenia, pain,
abdominal pain, headache, hypertension, diarrhea, nausea, vomiting,
anorexia, stomatitis, constipation, upper respiratory infection,
epistaxis, dyspnea, exfoliative dermatitis and proteinuria.
About Genentech
Founded more than 30 years ago, 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 and licenses several additional products to other
companies. The company has headquarters in South San Francisco,
California, and is listed on the New York Stock Exchange under the
symbol DNA. For additional information about the company, please
visit http://www.gene.com.
This press release contains a forward-looking statement regarding
the timing for additional study data. Such statement is a
prediction and involves risks and uncertainties such that the
actual result may differ materially. Among other things, the timing
for additional study data could be affected by unexpected safety or
efficacy issues, additional time requirements for data collection
and analysis or decision-making, discussions with the FDA or FDA
actions. Please also refer to Genentech's periodic reports filed
with the Securities and Exchange Commission. Genentech disclaims,
and does not undertake, any obligation to update or revise the
forward-looking statement in this press release.
Posted: November 2007
