Amgen Announces Results From Phase 3 PAVES Study Evaluating Neulasta (pegfilgrastim) In Patients With Colorectal Cancer

Sat Jan 26, 2013 10:00am EST

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Study Shows Neulasta Reduced the Incidence of Febrile Neutropenia in Patients
With Colorectal Cancer Receiving FOLFOX or FOLFIRI and Bevacizumab
THOUSAND OAKS, Calif.,  Jan. 26, 2013  /PRNewswire/ -- Amgen (NASDAQ:AMGN)
announced today results from Pegfilgrastim and Anti-VEGF Evaluation Study
(PAVES), a Phase 3 trial which evaluated Neulasta® (pegfilgrastim) in 845
patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line
treatment of locally-advanced or metastatic colorectal cancer. FOLFOX and
FOLFIRI are two of the most commonly used chemotherapy regimens for colorectal
cancer.

The study met its primary endpoint, with Neulasta significantly reducing the
incidence of febrile neutropenia. Febrile neutropenia is a low white blood cell
count accompanied by a fever.1  In the study, the incidence of grade 3 or 4
febrile neutropenia in patients receiving Neulasta across the first four cycles
of chemotherapy was 2.4 percent compared to 5.7 percent in the placebo group
(OR=0.41,  p=0.014). A similar incidence of grade 3 or higher adverse events was
seen in both arms of the trial (28 percent placebo; 27 percent Neulasta).

"This analysis showed that PAVES met its primary endpoint, with Neulasta
significantly reducing the incidence of febrile neutropenia in patients with
colorectal cancer," said  Sean E. Harper, M.D., executive vice president of
Research and Development at Amgen. "In addition to providing new data on
Neulasta, we believe PAVES will provide valuable information to the oncology
community on commonly-used chemotherapy regimens."

Full results will be presented on  Saturday, Jan. 26  during the 2013
Gastrointestinal Cancers Symposium, General Poster Session C (C1) by  Tamas
Pinter, M.D., the PAVES principal investigator, Aladar Korhaz Hospital,
Onkoradiologiai Osztaly, Gyor,  Hungary  (Late Breaking Abstract No. 445).  

Follow-up results of PAVES looking at additional endpoints, including mature
data on overall survival, overall response rate, time to progression and
progression-free survival, will be presented at a future date.   

About PAVES  

PAVES is a Phase 3, randomized, double-blind, placebo-controlled trial
evaluating Neulasta in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab
for the first-line treatment of locally-advanced or metastatic colorectal
cancer. The trial was multicenter and multinational. All patients received
treatment with either FOLFOX or FOLFIRI plus bevacizumab and were randomized to
one of two treatment arms that also received either placebo or 6 mg of Neulasta
at least 24 hours after each cycle of chemotherapy. The primary endpoint was the
incidence of grade 3 or 4 febrile neutropenia during the first four cycles. The
study was not designed to define the febrile neutropenia rate of FOLFOX or
FOLFIRI plus bevacizumab. Other endpoints include overall response rate,
progression-free survival, overall survival, time to progression and adverse
events.

About Febrile Neutropenia

One of the most common side effects of myelosuppressive chemotherapy is a low
white blood cell count.2  An abnormally low level of neutrophils, an important
infection-fighting white blood cell, is called neutropenia.2  The fewer
neutrophils a patient has - and the longer the neutrophil count remains low -
the greater the risk of developing a potentially serious infection.2, 3

Febrile neutropenia is neutropenia complicated by a fever.1  Fever is frequently
a sign of infection and, in patients receiving myelosuppressive chemotherapy, it
can sometimes be the only sign.2  Febrile neutropenia is a medical emergency and
is associated with several potential downstream consequences.2, 4

About Neulasta  

Neulasta was approved by the U.S. Food and Drug Administration (FDA) in 2002 to
decrease the incidence of infection, as manifested by febrile neutropenia, in
patients with nonmyeloid malignancies receiving myelosuppressive anticancer
drugs associated with a clinically significant incidence of febrile
neutropenia.5  Neulasta is not indicated for the mobilization of peripheral
blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information

Do not administer Neulasta to patients with a history of serious allergic
reactions to pegfilgrastim or Filgrastim.

Fatal splenic rupture can occur. Evaluate for splenomegaly or splenic rupture in
patients with left upper abdominal or shoulder pain. Acute respiratory distress
syndrome (ARDS) can occur. Evaluate for ARDS in patients who develop fever, lung
infiltrates, or respiratory distress. Discontinue Neulasta in patients with
ARDS. Serious allergic reactions, including anaphylaxis, can occur. Permanently
discontinue Neulasta in patients with serious allergic reactions. Severe and
sometimes fatal sickle cell crises have been reported.

Most common adverse reactions (≥ 5% difference in incidence) in
placebo-controlled clinical trials are bone pain and pain in extremity.

To see the full Neulasta Safety Information, visit 
www.amgen.com/medpro/products.html.  

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, bone disease 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. Follow us on  www.twitter.com/amgen.  

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
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additional information on the uncertainties and risk factors related to our
business.  Unless otherwise noted, Amgen is providing this information as of 
Jan. 26, 2013, and expressly disclaims any duty to update information contained
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No forward-looking statement can be guaranteed and actual results may differ
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CONTACT: Amgen,  Thousand Oaks
Ashleigh Koss, 805-313-6151 (media)
Arvind Sood, 805-447-1060 (investors)

1  Dictionary of Cancer Terms: Febrile Neutropenia. National Cancer Institute
website. Available at  www.cancer.gov/dictionary?CdrID=415543. Accessed  January
7, 2013.
2  "Chemotherapy and You" brochure. National Cancer Institute website. 
www.cancer.gov/cancertopics/coping/chemotherapy-and-you/page7#SE8.  Accessed 
January 7, 2013.  
3  Bodey GP, et al.  Ann Intern Med.  1966;64: 328-340.
4 Kuderer N, et al.  Cancer.  2006: 2006;106:2258-66.
5  Neulasta®  (pegfilgrastim) prescribing information, Amgen.

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SOURCE  Amgen

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