Vectibix(R) in Combination With Chemotherapy Significantly Improves Progression-Free Survival in First-Line Metastatic Colorectal Cancer

Thousand Oaks, California (ots/PRNewswire) -

Amgen (Nasdaq: AMGN) today announced detailed results from the
Phase 3 '203' trial evaluating Vectibix(R) (panitumumab) administered
in combination with FOLFOX (an oxaliplatin-based chemotherapy) as the
first-line treatment of metastatic colorectal cancer (mCRC). In this
trial, Vectibix significantly improved median progression-free
survival (PFS) by 1.6 months (9.6 versus 8.0 months for patients
treated with FOLFOX alone, (hazard ratio 0.80; p=0.02)) in patients
with KRAS wild-type mCRC (primary endpoint). The results were
presented at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary
Congress in Berlin, Germany (Abstract Number 10LBA).

Further, the addition of Vectibix to chemotherapy also improved
response rate in the KRAS wild-type patient population as measured by
blinded central review (55 percent versus 48 percent in the FOLFOX
only arm).

"I am very pleased with the outcome of this high quality trial
which demonstrated that Vectibix improved progression-free survival
and appeared to be well tolerated as a first-line metastatic
colorectal cancer treatment in a selected patient population," said
Jean-Yves Douillard, director Clinical and Translational Research,
Medical Oncology Branch, Centre R Gauducheau, France and the study's
principal investigator. "This is the first prospective Phase 3 data
to demonstrate the importance of KRAS mutation as a predictive
biomarker for Vectibix treatment in the first-line setting, providing
definitive support for the use of the KRAS biomarker for selection of
patients eligible for anti-EGFR therapy."

Importantly, in patients with tumors harboring activating KRAS
mutations, PFS was significantly inferior in the Vectibix arm. For
patients with mutant KRAS tumors, median PFS was 7.3 months with
Vectibix in combination with FOLFOX vs. 8.8 months with FOLFOX alone
(hazard ratio 1.29, p=0.02). These data confirm previous findings
when oxaliplatin-based chemotherapy and an anti-epidermal growth
factor receptor (EGFR) antibody are combined in patients bearing
tumors with activating KRAS mutations.

Consistent with the PFS data, an interim analysis of overall
survival, a secondary endpoint, demonstrated a reduction in overall
survival in patients with KRAS mutant tumors receiving Vectibix. The
median overall survival for patients with KRAS wild-type mCRC has not
yet been reached. Long-term follow-up for survival continues and the
primary analysis is expected in the fourth quarter of 2009.

Adverse event 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 infusion reactions were
reported for two patients (less than 1 percent).

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 93 percent of
the 1,183 patients enrolled in the trial, the highest percentage ever
reported. Tumor KRAS tests were finalized after the completion of
enrollment and prior to the primary analysis.

Earlier this week, data were presented from the '181' trial which
showed that Vectibix administered in combination with FOLFIRI (an
irinotecan-based chemotherapy) prolonged PFS by 2 months in patients
with KRAS wild-type mCRC, compared to treatment with FOLFIRI alone
(Abstract Number 14LBA).

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 www.amgen.com, under Investors. The audio webcast will be archived
and available for replay for at least 72 hours.

Study Design

Patients enrolled in the '203' or PRIME trial (Panitumumab
Randomized trial In combination with chemotherapy for Metastatic
colorectal cancer to determine Efficacy) were randomized to receive
either 6.0 mg/kg of Vectibix and FOLFOX4 once every two weeks (Q2W)
or FOLFOX4 alone Q2W. The primary endpoint of the study is
progression-free survival by KRAS status and secondary endpoints
include overall survival, objective response rate, time to
progression, duration of response and safety. Long-term follow up for
overall survival is ongoing.

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 greater
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 www.amgen.com.

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CONTACT: Amgen, Thousand Oaks
Christine Regan: +1-805-447-5476 (media U.S.)
Wendy Woods: +41-(0)-41-3692-542 (media Europe)
Arvind Sood: +1-805-447-1060 (investors)

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Contact:
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