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

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

Study Shows Neulasta Reduced the Incidence of Febrile Neutropenia in Patients
With Colorectal Cancer Receiving FOLFOX or FOLFIRI and Bevacizumab

PR Newswire

THOUSAND OAKS, Calif., Jan. 26, 2013

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

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

"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.


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

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 Follow us on

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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 Accessed January
7, 2013.
^2 "Chemotherapy and You" brochure. National Cancer Institute website. 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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