New AMG 479 Phase 2 Data Show Antitumor Activity in Patients With Metastatic Pancreatic Cancer
AMG 479 Extended Progression-Free Survival And Overall Survival Compared To Gemcitabine Alone AMG 479 Moving Into Phase 3 For Metastatic Pancreatic Cancer
THOUSAND OAKS, Calif., June 4 /PRNewswire-FirstCall/ -- Amgen
(NASDAQ: AMGN) today announced results from a
small, randomized, placebo-controlled Phase 2 study indicating that
adding AMG 479 to gemcitabine improved overall survival at six
months (primary endpoint) and progression-free survival in patients
with metastatic pancreatic cancer. The study, which also included a
separate arm of conatumumab plus gemcitabine, is being presented in
a Poster Discussion at the 2010 American Society of Clinical
Oncology (ASCO) Annual Meeting. (Abstract Number: 4035)
AMG 479 is an investigational fully human monoclonal antibody
that targets type 1 insulin-like growth factor receptor (IGF-1R).
Signaling through IGF-1R plays an important role in the regulation
of cell growth and survival. Conatumumab is an investigational
fully human monoclonal antibody agonist that targets death receptor
5 (DR-5) and induces apoptosis - programmed cell death - in
sensitive tumor cells.
"Pancreatic cancer has the worst survival of any solid tumor,
and novel approaches to treat this disease are needed," said Dr.
Hedy Kindler, M.D., associate professor of Medicine, medical
director, Gastrointestinal Oncology and director, Mesothelioma
Program, University of Chicago Medical Center. "In this study, AMG
479 demonstrated promising activity, extending progression-free
survival three months and overall survival nearly three months
compared to gemcitabine alone."
Patients were randomized to receive AMG 479 plus gemcitabine
(n=40), conatumumab plus gemcitabine (n=41), or placebo plus
The addition of AMG 479 to gemcitabine resulted in an overall
survival rate at six months of 57 percent versus 50 percent with
gemcitabine alone (95 percent CI, 41 - 70) and 39 percent versus 23
percent at 12 months (95 percent CI, 25 - 54). Median overall
survival was 8.7 months versus 5.9 months in the gemcitabine arm
(95 percent CI, 5.3 - 12.2). Patients receiving AMG 479 also
experienced longer progression-free survival of 5.1 months versus
2.1 months (95 percent CI, 2.8 - 5.8).
The study also showed evidence of anti-tumor activity with
conatumumab. Patients in the conatumumab arm experienced an overall
survival rate at six months of 59 percent versus 50 percent (95
percent CI, 42 - 73) compared to gemcitabine alone and 20 percent
versus 23 percent at 12 months (95 percent CI, 9 - 34). Patients
receiving conatumumab experienced progression-free survival of 4.0
months versus 2.1 months compared to gemcitabine alone (95 percent
CI, 3.3 - 5.0).
Both AMG 479 and conatumumab in combination with gemcitabine
were tolerable. Grade 3 or higher adverse events observed included
neutropenia (AMG 479/conatumumab/ placebo arm percentages
18/22/13), thrombocytopenia (15/17/8), abdominal pain (8/17/13),
and fatigue (13/12/5).
Pancreatic cancer is the fourth leading cause of cancer-related
death in the United States. In 2009, there were more than 42,000
new cases of pancreatic cancer and 35,000 deaths from the disease.
(i) Because diagnosis and intervention occur late in the course of
this disease, the vast majority of patients already have metastatic
disease at the time of diagnosis.(ii)
Amgen will hold an analyst/investor event at a local venue in
Chicago on Monday, June 7 at 7:30 p.m. Central Time to discuss data
presented at ASCO. A webcast of the event can be found on Amgen's
website at www.amgen.com, under Investors. The audio webcast will
be archived and available for replay for at least 72 hours.
Amgen discovers, develops, manufactures and delivers innovative
human therapeutics. A biotechnology pioneer since 1980, Amgen was
one of the first companies to realize the new science's promise by
bringing safe and effective medicines from lab, to manufacturing
plant, to patient. Amgen therapeutics have changed the practice of
medicine, helping millions of people around the world in the fight
against cancer, kidney disease, rheumatoid arthritis, and other
serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to
dramatically improve people's lives. To learn more about our
pioneering science and our vital medicines, visit http://www.amgen.com/.
This news release contains forward-looking statements that are
based on management's current expectations and beliefs and are
subject to a number of risks, uncertainties and assumptions that
could cause actual results to differ materially from those
described. All statements, other than statements of historical
fact, are statements that could be deemed forward-looking
statements, including estimates of revenues, operating margins,
capital expenditures, cash, other financial metrics, expected
legal, arbitration, political, regulatory or clinical results or
practices, customer and prescriber patterns or practices,
reimbursement activities and outcomes and other such estimates and
results. Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission (SEC) reports
filed by Amgen, including Amgen's most recent annual report on Form
10-K and most recent periodic reports on Form 10-Q and Form 8-K.
Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for
additional information on the uncertainties and risk factors
related to our business. Unless otherwise noted, Amgen is providing
this information as of June 4, 2010 and expressly disclaims any
duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. We develop product candidates internally
and through licensing collaborations, partnerships and joint
ventures. Product candidates that are derived from relationships
may be subject to disputes between the parties or may prove to be
not as effective or as safe as we may have believed at the time of
entering into such relationship. Also, we or others could identify
safety, side effects or manufacturing problems with our products
after they are on the market. Our business may be impacted by
government investigations, litigation and products liability
claims. We depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
future products and limits on supply may constrain sales of certain
of our current products and product candidate development.
In addition, sales of our products are affected by the
reimbursement policies imposed by third-party payors, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we
routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and
there can be no guarantee of our ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of
significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our
business and results of operations.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration (FDA), and no conclusions can or should be drawn
regarding the safety or effectiveness of the product candidates.
Only the FDA can determine whether the product candidates are safe
and effective for the use(s) being investigated. Further, the
scientific information discussed in this news release relating to
new indications for our products is preliminary and investigative
and is not part of the labeling approved by the U.S. Food and Drug
Administration (FDA) for the products. The products are not
approved for the investigational use(s) discussed in this news
release, and no conclusions can or should be drawn regarding the
safety or effectiveness of the products for these uses. Only the
FDA can determine whether the products are safe and effective for
these uses. Healthcare professionals should refer to and rely upon
the FDA-approved labeling for the products, and not the information
discussed in this news release.
CONTACT: Amgen, Thousand Oaks Leanne Madison: +1 (805) 603-9241 (media) Arvind Sood: +1 (805) 447-1060 (investors)
(i) National Cancer Institute. Available at: http://www.cancer.gov/cancertopics/types/pancreatic.
Accessed April 15, 2010
(ii) National Cancer Institute: A Snapshot of Pancreatic Cancer.
Available at: http://www.cancer.gov/aboutnci/servingpeople/snapshots/Pancreatic.pdf.
Accessed April 15, 2010.
CONTACT: Thousand Oaks, media, Leanne Madison, +1-805-603-9241,
investors, Arvind Sood, +1-805-447-1060, both of Amgen
Web Site: http://www.amgen.com/
Posted: June 2010