Genentech, Inc. (NYSE: DNA) today announced encouraging results from a
randomized Phase II study comparing pertuzumab plus gemcitabine to
gemcitabine alone in women with platinum-resistant ovarian, primary
peritoneal, or fallopian tube cancer. Data from the study will be submitted
for presentation at an upcoming medical meeting.
Pertuzumab or 2C4, a humanized antibody formerly known as Omnitarg, is
the first in a new class of investigational agents known as HER
dimerization inhibitors (HDIs). Pertuzumab is designed to bind to the HER2
receptor - a protein found on the surface of epithelial cells - and inhibit
the ability of HER2 to interact with other HER family receptors (HER1,
HER2, HER3, and HER4). HER dimerization (pairing) is believed to play an
important role in the growth and formation of several different cancer
types.
"Advanced ovarian cancer continues to be a difficult-to-treat cancer
with few approved treatment options," said Hal Barron, Genentech senior
vice president, Development and chief medical officer. "We are encouraged
by the results of this trial, and will continue to analyze the data to help
determine next steps for the pertuzumab development program."
In this study, no new or unexpected safety signals were observed.
Adverse events were similar to those observed in previous clinical trials
of pertuzumab and included fatigue, diarrhea, back pain, and neutropenia.
The cardiac safety profile in the pertuzumab arm was similar to that of the
gemcitabine-alone arm; there was one congestive heart failure event
reported in the pertuzumab arm. More detailed information about adverse
events will be available when the data are presented.
About the Study
In this Phase II, placebo-controlled, double-blinded, multi-center
study, 130 women with advanced ovarian, primary peritoneal, or fallopian
tube cancer were enrolled and received treatment with pertuzumab plus
gemcitabine, or gemcitabine alone. Eligible patients must have experienced
disease progression within six months of receiving a platinum-based
chemotherapy regimen that did not contain gemcitabine or any other HER
receptor targeting agent. Patients who had received more than one prior
chemotherapy regimen for platinum-resistant disease, or more than one
non-platinum-containing regimen for platinum-sensitive disease, were
excluded from the study. The primary endpoint of the study was
progression-free survival. Exploratory diagnostic marker data to help
evaluate if HER2 receptor activation may be a predictor of clinical
response were collected as part of this trial, and are currently being
analyzed.
About Pertuzumab
Pertuzumab is a humanized monoclonal antibody designed to bind to the
HER2 receptor and inhibit the ability of HER2 to interact with other HER
family members (HER1, HER2, HER3, and HER4). The HER signaling pathway
plays a role in the formation and growth of numerous cancers, and previous
clinical trials of pertuzumab in a single agent setting had suggested
clinical activity - including stable disease - in heavily pretreated
patients with advanced ovarian and breast cancers. Genentech and Roche are
evaluating pertuzumab in solid tumors (ovarian and breast cancers), and in
combination with other therapies. Diagnostic analyses to evaluate if HER2
receptor activation may be a predictor of clinical response, with the goal
of helping oncologists select patients most likely to respond to
pertuzumab, are a component of all ongoing pertuzumab clinical trials.
About Ovarian Cancer
The American Cancer Society (ACS) estimates that in 2006, approximately
20,180 women will have been diagnosed with ovarian cancer and 15,310 will
have died of the disease. Ovarian cancer is the eighth most common cancer
among women, and is the fifth most common cause of cancer death among
women. According to the ACS, fallopian tube cancer and primary peritoneal
cancers often are grouped with the ovarian cancer category of tumors, as
symptoms and treatment are similar.
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
conducting clinical development programs for Rituxan(R) (Rituximab),
Herceptin(R) (Trastuzumab), Avastin(R) (bevacizumab), and Tarceva(R)
(erlotinib), and markets all four products in the United States, either
alone (Avastin and Herceptin) or with Biogen Idec Inc. (Rituxan), or OSI
Pharmaceuticals, Inc. (Tarceva).
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. An investigational antibody
directed at the HER pathway is currently in Phase II trials. In early
development, are a small molecule directed at the hedgehog pathway and an
investigational agent targeting apoptosis.
Founded 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, Calif., and is listed on
the New York Stock Exchange under the symbol DNA. For additional
information about the company, please visit gene/.
Genentech, Inc.
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