Amgen Presents Complete Results From Two Pivotal Phase 3 Studies of Vectibix(R) at Gastrointestinal Cancers Symposium
22 January 2010 - 1:00AM
PR Newswire (US)
THOUSAND OAKS, Calif., Jan. 21 /PRNewswire-FirstCall/ -- Amgen
(NASDAQ: AMGN) today announced that detailed results from two
pivotal Phase 3 studies evaluating Vectibix® (panitumumab) in
combination with chemotherapy for the first and second-line
treatment of metastatic colorectal cancer (mCRC) (the PRIME '203'
and '181' trials, respectively) will be presented at the 2010
American Society of Clinical Oncology (ASCO) Gastrointestinal
Cancers Symposium in Orlando, Florida from Jan. 22-24, 2010. "The
results from the 203 and 181 trials evaluating Vectibix
administered in combination with chemotherapy in first and
second-line treatment provide important information for patients
with metastatic colorectal cancer and the physicians who care for
them," said Roger M. Perlmutter, M.D., Ph.D., executive vice
president of Research and Development at Amgen. "Our data reinforce
the importance of the KRAS mutation as a predictive biomarker for
responsiveness to Vectibix therapy. We believe that KRAS testing
should be conducted in all patients with colorectal cancer soon
after diagnosis, to allow physicians to choose the most appropriate
treatment strategies for their patients." Full data from these two
pivotal Phase 3 studies will be presented on Sunday, January 24, at
10:30 a.m. (EST). Identified below are selected abstracts of
interest. Updated data will be presented at the meeting. SELECTED
ABSTRACTS OF INTEREST -- Randomized phase 3 study of panitumumab
(pmab) with FOLFIRI vs FOLFIRI alone as 2nd-line treatment (tx) in
patients (pts) with metastatic colorectal cancer (mCRC): Patient
reported outcomes (PRO) Lead Author: Peeters M Abstract No. 282
(Sunday, Jan. 24, 2010, 10:30 a.m.-12:00 p.m.) -- Randomized phase
3 study of panitumumab (pmab) with FOLFOX4 compared to FOLFOX4
alone as first-line treatment (tx) for metastatic colorectal cancer
(mCRC): PRIME trial Lead Author: Siena S Abstract No. 283 (Sunday,
Jan. 24, 2010, 10:30 a.m.-12:00 p.m.) -- Primary analysis of a
phase II study (20060314) combining first line panitumumab (pmab)
with FOLFIRI in the treatment of patients (pts) with metastatic
colorectal cancer (mCRC) Lead Author: Koehne C-H Abstract No. 414
(Sunday, Jan. 24, 2010, 7:00-8:00 a.m., 12:00-1:00 p.m.) --
Epidermal-growth factor receptor (EGFR) inhibitor-related skin
toxicity: review of primary analysis data from a phase II study
(20060314) of panitumumab (pmab) with FOLFIRI in the first line
treatment of metastatic colorectal cancer (mCRC) Lead Author:
Karthaus M Abstract No. 429 (Sunday, Jan. 24, 2010, 7:00-8:00 a.m.,
12:00-1:00 p.m.) About Vectibix Vectibix is the first fully human
anti-EGFR antibody approved by the United States (U.S.) Food and
Drug Administration (FDA) for the treatment of mCRC. Vectibix was
approved in the U. S. in September 2006 as monotherapy for the
treatment of patients with EGFRexpressing metastatic colorectal
carcinoma 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. Retrospective subset
analyses of metastatic colorectal cancer trials have not shown a
treatment benefit for Vectibix in patients whose tumors had KRAS
mutations in codon 12 or 13. Use of Vectibix is not recommended for
the treatment of colorectal cancer with these mutations. In
December 2007, the European Medicines Agency (EMA) granted a
conditional marketing authorization for Vectibix as monotherapy for
the treatment of patients with EGFR expressing metastatic
colorectal carcinoma with non-mutated (wild-type) KRAS after
failure of fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy regimens. Vectibix has been
launched in over 20 EU countries, Russia, Switzerland, Australia
and Canada. Applications in the rest of the world 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 Jan. 21,
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 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 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
Ashleigh Koss: +1 (805) 313-6151 (media) Arvind Sood: +1 (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,
Ashleigh Koss, +1-805-313-6151, or investors, Arvind Sood,
+1-805-447-1060, both of Amgen, Thousand Oaks Web Site:
http://www.amgen.com/
Copyright