New AMG 479 Phase 2 Data Show Antitumor Activity in Patients With Metastatic Pancreatic Cancer
AMG 479 Extended Progression-Free Survival And Overall Survival Compared To Gemcitabine Alone AMG 479 Moving Into Phase 3 For Metastatic Pancreatic Cancer
THOUSAND OAKS, Calif., June 4 /PRNewswire-FirstCall/ -- Amgen
(NASDAQ: AMGN) today announced results from a
small, randomized, placebo-controlled Phase 2 study indicating that
adding AMG 479 to gemcitabine improved overall survival at six
months (primary endpoint) and progression-free survival in patients
with metastatic pancreatic cancer. The study, which also included a
separate arm of conatumumab plus gemcitabine, is being presented in
a Poster Discussion at the 2010 American Society of Clinical
Oncology (ASCO) Annual Meeting. (Abstract Number: 4035)
AMG 479 is an investigational fully human monoclonal antibody
that targets type 1 insulin-like growth factor receptor (IGF-1R).
Signaling through IGF-1R plays an important role in the regulation
of cell growth and survival. Conatumumab is an investigational
fully human monoclonal antibody agonist that targets death receptor
5 (DR-5) and induces apoptosis - programmed cell death - in
sensitive tumor cells.
"Pancreatic cancer has the worst survival of any solid tumor,
and novel approaches to treat this disease are needed," said Dr.
Hedy Kindler, M.D., associate professor of Medicine, medical
director, Gastrointestinal Oncology and director, Mesothelioma
Program, University of Chicago Medical Center. "In this study, AMG
479 demonstrated promising activity, extending progression-free
survival three months and overall survival nearly three months
compared to gemcitabine alone."
Patients were randomized to receive AMG 479 plus gemcitabine
(n=40), conatumumab plus gemcitabine (n=41), or placebo plus
The addition of AMG 479 to gemcitabine resulted in an overall
survival rate at six months of 57 percent versus 50 percent with
gemcitabine alone (95 percent CI, 41 - 70) and 39 percent versus 23
percent at 12 months (95 percent CI, 25 - 54). Median overall
survival was 8.7 months versus 5.9 months in the gemcitabine arm
(95 percent CI, 5.3 - 12.2). Patients receiving AMG 479 also
experienced longer progression-free survival of 5.1 months versus
2.1 months (95 percent CI, 2.8 - 5.8).
The study also showed evidence of anti-tumor activity with
conatumumab. Patients in the conatumumab arm experienced an overall
survival rate at six months of 59 percent versus 50 percent (95
percent CI, 42 - 73) compared to gemcitabine alone and 20 percent
versus 23 percent at 12 months (95 percent CI, 9 - 34). Patients
receiving conatumumab experienced progression-free survival of 4.0
months versus 2.1 months compared to gemcitabine alone (95 percent
CI, 3.3 - 5.0).
Both AMG 479 and conatumumab in combination with gemcitabine
were tolerable. Grade 3 or higher adverse events observed included
neutropenia (AMG 479/conatumumab/ placebo arm percentages
18/22/13), thrombocytopenia (15/17/8), abdominal pain (8/17/13),
and fatigue (13/12/5).
Pancreatic cancer is the fourth leading cause of cancer-related
death in the United States. In 2009, there were more than 42,000
new cases of pancreatic cancer and 35,000 deaths from the disease.
(i) Because diagnosis and intervention occur late in the course of
this disease, the vast majority of patients already have metastatic
disease at the time of diagnosis.(ii)
Amgen will hold an analyst/investor event at a local venue in
Chicago on Monday, June 7 at 7:30 p.m. Central Time to discuss data
presented at ASCO. A webcast of the event can be found on Amgen's
website at www.amgen.com, under Investors. The audio webcast will
be archived and available for replay for at least 72 hours.
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(i) National Cancer Institute. Available at: http://www.cancer.gov/cancertopics/types/pancreatic.
Accessed April 15, 2010
(ii) National Cancer Institute: A Snapshot of Pancreatic Cancer.
Available at: http://www.cancer.gov/aboutnci/servingpeople/snapshots/Pancreatic.pdf.
Accessed April 15, 2010.
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CONTACT: Thousand Oaks, media, Leanne Madison, +1-805-603-9241,
investors, Arvind Sood, +1-805-447-1060, both of Amgen
Web Site: http://www.amgen.com/
Posted: June 2010