Amgen to Present Pivotal Data From Four Phase 3 Studies at the ECCO 15 - ESMO 34 Congress
September 16 2009 - 9:00AM
PR Newswire (US)
Key Denosumab and Vectibix(R) (Panitumumab) Data to be Presented
THOUSAND OAKS, Calif., Sept. 16 /PRNewswire-FirstCall/ -- Amgen
(NASDAQ: AMGN) today announced it will present detailed data from
four Phase 3 studies as well as other data at the ECCO 15 - ESMO 34
European Multidisciplinary Congress, September 20 - 24, 2009 in
Berlin, Germany. Researchers will present data from two Phase 3
head-to-head studies evaluating denosumab versus Zometa (zoledronic
acid) for the treatment of bone metastases in patients with
advanced breast cancer (the '136' study) and the treatment of bone
metastases in advanced cancer patients with solid tumors (not
including breast and prostate cancer) or multiple myeloma (the
'244' study). Detailed data will also be presented from two Phase 3
studies evaluating Vectibix (panitumumab) in combination with
chemotherapy for the first-line and second-line treatment of
metastatic colorectal cancer (the '203' and '181' trials,
respectively). "Amgen is very pleased to be presenting these
important data from the denosumab and Vectibix development
programs," said Roger M. Perlmutter, M.D., Ph.D., executive vice
president of Research and Development at Amgen. "The data from
these trials demonstrate that both denosumab and Vectibix have the
potential to improve outcomes in patients suffering from cancer."
SELECTED ABSTRACTS OF INTEREST Identified below are selected
abstracts of interest on Amgen research. Updated data will be
presented at the meeting. Denosumab -- A double-blind, randomized
study of denosumab versus zoledronic acid for the treatment of bone
metastases in patients with advanced cancer (excluding breast and
prostate cancer) or multiple myeloma Lead Author: Henry, D.
Abstract No. 20LBA (Monday, Sept. 21, 2009, 12:45 -13:00 CEST) --
Denosumab versus zoledronic acid for the treatment of breast cancer
patients with bone metastases: Results of a randomized Phase 3
study Lead Author: Stopeck, A. Abstract No. 2LBA (Tuesday, Sept.
22, 2009, 14:15 - 14:30 CEST) -- Overall survival in men with and
without prevalent vertebral fracture receiving androgen deprivation
therapy for nonmetastatic prostate cancer Lead Author: Smith, M.
Abstract No. 7005 (Monday, Sept. 21, 2009, 12:15 -12:45 CEST)
Vectibix -- Randomized Phase 3 study of panitumumab with FOLFIRI vs
FOLFIRI alone as second-line treatment (tx) in patients (pts) with
metastatic colorectal cancer (mCRC) Lead Author: Peeters, M.
Abstract No. 14LBA (Tuesday, Sept. 22, 2009, 10:45 - 11:00 CEST) --
Randomized Phase 3 study of panitumumab with FOLFOX compared to
FOLFOX alone as first-line treatment (tx) for metastatic colorectal
cancer (mCRC): The PRIME trial Lead Author: Douillard, J.Y.
Abstract No. 10LBA (Thursday, Sept. 24, 2009, 11:00 - 11:15 CEST)
An analyst/investor event will also be held from the Congress on
September 24th, at 6:30 a.m. ET 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. About
Denosumab Denosumab is the first fully human monoclonal antibody in
late stage clinical development that specifically targets RANK
Ligand, the essential regulator of osteoclasts (the cells that
break down bone). With more than 19,000 patients in trials across
indications worldwide, the denosumab development program is the
largest ever initiated by Amgen. This broad and deep development
program demonstrates Amgen's commitment to researching and
delivering pioneering medicines to patients with unmet medical
needs. Amgen is studying denosumab in numerous tumor types across
the spectrum of cancer induced bone disease. Over 11,000 patients
have been enrolled in the denosumab oncology clinical trials
testing the drug for bone loss and destruction associated with
cancer treatment-induced bone loss in breast and prostate cancers,
for the prevention of skeletal related events due to the spread of
cancer to the bone in multiple myeloma and multiple solid tumors,
and for its potential to delay bone metastases in prostate cancer.
In two phase 3 skeletal related events studies reported to date,
the incidence of adverse events and serious adverse events was
consistent with what has previously been reported for denosumab and
Zometa. Osteonecrosis of the jaw (ONJ) was seen infrequently in
both treatment groups. About Vectibix Vectibix is the first fully
human anti-EGFR 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. In December 2007, the
European Commission 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, including Switzerland, Australia and Canada.
Applications in the rest of the world are pending. 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.
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 lesser 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
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