THOUSAND OAKS, Calif., Sept. 22 /PRNewswire-FirstCall/ -- Amgen
(NASDAQ: AMGN) today announced detailed results from the Phase 3
'181' trial evaluating Vectibix (panitumumab) in combination with
FOLFIRI (an irinotecan based chemotherapy), as a second-line
treatment for metastatic colorectal cancer (mCRC). In this trial,
Vectibix significantly improved progression-free survival (PFS) in
patients with KRAS wild-type mCRC. These results were presented at
the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in
Berlin, Germany (Abstract Number 14LBA). The addition of Vectibix
to FOLFIRI significantly improved median PFS (co-primary endpoint)
by two months (5.9 versus 3.9 months for patients treated with
FOLFIRI alone, hazard ratio 0.73, p=0.004) in patients with KRAS
wild-type mCRC. Although numerically greater (14.5 months versus
12.5 months; hazard ratio 0.85), the improvement in median overall
survival (co-primary endpoint) in the Vectibix arm did not achieve
statistical significance (p=0.115) in the same patient population.
Further, the addition of Vectibix to FOLFIRI resulted in greater
than a three-fold improvement (35 percent versus 10 percent) in
response rate in the KRAS wild-type patient population as measured
by a blinded central review. "This study showed that Vectibix can
be safely administered in combination with FOLFIRI chemotherapy.
Vectibix delayed disease progression by more than half compared to
FOLFIRI alone in patients with previously treated KRAS wild-type
colorectal cancer," said Marc Peeters, M.D., Ph.D., coordinator of
Digestive Oncology Unit, University Hospital Ghent and the study's
principal investigator. "Further, the response rate seen in this
trial is among the highest ever reported in the second-line
metastatic CRC setting." In general, adverse events rates were
comparable across arms with the exception of known toxicities
associated with anti-epidermal growth factor receptor (EGFR)
therapy such as rash, diarrhea, and hypomagnesemia.
Vectibix-related grade 3/4 infusion reactions were reported in less
than one percent of patients. There were no differences in
progression-free survival, overall survival and response rates
among patients with mutated KRAS who received Vectibix. Originally
designed to compare the treatment effect in the overall population,
the study was amended to analyze outcomes with respect to the
presence or absence of activating mutations in KRAS in the tumor
itself. Tumor KRAS status was ascertained in 91 percent of the
1,186 patients enrolled in this trial, the highest number ever
reported for a second-line trial. "These high quality prospectively
defined analyses prove the clinical utility of KRAS as a predictive
biomarker in metastatic colorectal cancer patients," added Peeters.
Webcast Information An analyst/investor event will also be held
from the Congress on September 24th, at 6:30 a.m. Eastern Time to
discuss data presented at ECCO-ESMO. A webcast of the event can be
found on Amgen's Web site at http://www.amgen.com/, under
Investors. The audio webcast will be archived and available for
replay for at least 72 hours. Study Design The "181" trial is a
global, multicenter, randomized Phase 3 study. Patients enrolled in
the study were randomized to receive either 6.0 mg/kg of Vectibix
and FOLFIRI every two weeks (Q2W) or FOLFIRI alone Q2W. The
independently tested co-primary endpoints were progression-free
survival and overall survival. Secondary endpoints included
objective response rate, time to progression, duration of response
and safety by KRAS status. About KRAS Results from studies
performed over the last twenty-five years indicate that KRAS plays
an important role in cell growth regulation. In mCRC, EGFR
transmits signals through a set of intracellular proteins. Upon
reaching the nucleus, these signals instruct the cancer cell to
reproduce and metastasize, leading to cancer progression. Anti-EGFR
antibody therapies work by blocking the activation of EGFR, thereby
inhibiting downstream events that lead to malignant signaling.
However, it is hypothesized that in patients whose tumors harbor a
mutated KRAS gene, the KRAS protein is always turned "on,"
regardless of whether the EGFR has been activated or
therapeutically inhibited. KRAS mutations occur in approximately 40
- 50 percent of mCRC. About Colorectal Cancer Colorectal cancer is
the fourth most common cancer in men and the third most common
cancer in women worldwide. In 2007, approximately 1.2 million cases
of colorectal cancer were expected to occur globally. With more
than 630,000 deaths worldwide per year, it is the second leading
cause of cancer-related death in the Western world. The highest
incidence rates are found in Japan, North America, parts of Europe,
New Zealand, and Australia, and rates are low in Africa and
South-East Asia. Rates are substantially higher in men than in
women. About Vectibix Vectibix is the first fully human anti-EGFR
antibody approved by the U.S. Food and Drug Administration (FDA)
for the treatment of mCRC. Vectibix was approved in the United
States in September 2006 as a monotherapy for the treatment of
patients with EGFR expressing mCRC after disease progression on or
following fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy regimens. The effectiveness of
Vectibix as a single agent for the treatment of EGFR-expressing,
metastatic colorectal carcinoma is based on progression-free
survival. Currently no data are available that demonstrate an
improvement in disease-related symptoms or increased survival with
Vectibix. Vectibix has not shown a treatment benefit for patients
whose tumors had KRAS mutations in codon 12 or 13. In December
2007, the EMEA granted a conditional marketing authorization for
Vectibix as monotherapy for the treatment of patients with
EGFR-expressing mCRC with wild-type KRAS genes after failure of
standard chemotherapy regimens. Vectibix has been launched in over
20 countries, Switzerland, Australia and Canada. Applications in
the rest of the world, including Japan, are pending. Important
Product Safety Information Dermatologic Toxicity: Dermatologic
toxicities occurred in 89 percent of patients and were severe
(NCI-CTC grade 3 and higher) in 12 percent of patients receiving
Vectibix monotherapy. Withhold Vectibix for dermatologic toxicities
that are grade 3 or higher or are considered intolerable. If
toxicity does not improve to less than or equal to grade 2 within 1
month, permanently discontinue Vectibix. The clinical
manifestations included, but were not limited to, dermatitis
acneiform, pruritus, erythema, rash, skin exfoliation, paronychia,
dry skin, and skin fissures. Subsequent to the development of
severe dermatologic toxicities, infectious complications, including
sepsis, septic death, and abscesses requiring incisions and
drainage were reported. Infusion Reactions: Severe infusion
reactions occurred in approximately 1 percent of patients. Severe
infusion reactions included anaphylactic reactions, bronchospasm,
and hypotension. Although not reported with Vectibix, fatal
infusion reactions have occurred with other monoclonal antibody
products. Stop infusion if a severe infusion reaction occurs.
Depending on the severity and/or persistence of the reaction,
permanently discontinue Vectibix. About Amgen 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/. Forward-Looking
Statements 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 Sept. 22, 2009 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 health
care 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 relating to new indications for our
products is preliminary and investigative and is not part of the
labeling approved by the 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
Christine Regan: 805-447-5476 (media U.S.) Wendy Woods: +41 (0) 41
3692 542 (media Europe) Arvind Sood: 805-447-1060 (investors)
(Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)
http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO
http://photoarchive.ap.org/ DATASOURCE: Amgen CONTACT: media U.S.,
Christine Regan, +1-805-447-5476, or media Europe, Wendy Woods, +41
(0) 41 3692 542, or investors, Arvind Sood, +1-805-447-1060, all of
Amgen, Thousand Oaks Web Site: http://www.amgen.com/
Copyright