Final Results of Phase 3 Head-to-Head Study Demonstrate Aranesp Dosed Every Two Weeks is Comparable to Epoetin Alfa Dosed Weekly in Cancer Patients with Chemotherapy-Induced Anemia
ORLANDO, Fla.--(BUSINESS WIRE)--May 15, 2005--Amgen Inc.
- Randomized Head-to-Head Study of Anemia Treatments Shows
Comparability in Transfusion Rates and Achievement of Target
Hemoglobin in More Than 1,200 Patients with
Amgen Inc., (NASDAQ:AMGN) the world's largest biotechnology
company, today announced that final results of a Phase 3 randomized,
head-to-head study demonstrated that 200 mcg of Aranesp(R)
(darbepoetin alfa) administered every two weeks is as effective as
40,000 U of Epoetin alfa dosed once a week in boosting hemoglobin
levels and reducing the need for red blood cell transfusions in cancer
patients with chemotherapy-induced anemia. The data were presented
today at the 41st Annual Meeting of the American Society of Clinical
Oncology (ASCO). (Abstract #8125)
"This is the largest, randomized head-to-head comparison of
darbepoetin alfa dosed every two weeks to Epoetin alfa dosed weekly,
as they are most often used in current oncology practice," said John
Glaspy, MD, professor, David Geffen School of Medicine, University of
California at Los Angeles. "Less frequent dosing provides anemia
management with less frequent injections, and for patients receiving
chemotherapy every two or three weeks, less frequent office visits.
Our data demonstrate that less frequent injections can be accomplished
without a compromise in efficacy in terms of decreased transfusion
risk or improved quality of life."
In the Phase 3 head-to-head study, a total of 1,220 patients with
chemotherapy-induced anemia were randomized to receive either Aranesp
200 mcg every two weeks (n=613) or Epoetin alfa 40,000 U once a week
(n=607). The majority of patients in both groups achieved the target
hemoglobin of greater than or equal to 11 g/dL. Both groups of
patients had similar blood transfusion rates, patient reported
outcomes, and safety endpoints.
In this study, at least 90 percent of patients in both arms of the
study achieved target hemoglobin of greater than or equal to 11 g/dL.
Seventy-four percent of patients in the Aranesp group remained in the
target range compared to 80 percent in the Epoetin alfa group. The
study's primary endpoint was designed to evaluate non-inferiority with
respect to transfusion rate. Transfusions were similar in the two
treatment groups (21 percent in the Aranesp group and 16 percent in
the Epoetin alfa group) demonstrating non-inferiority of Aranesp and
Epoetin alfa with respect to transfusion requirements.
The number and type of adverse events were similar between the two
groups and were consistent with the adverse event profile for this
population of anemic cancer patients receiving Aranesp.
New interim data from a study of Aranesp administered every three
weeks were also presented during the ASCO Annual Meeting (Abstract
#8129). In May, Amgen announced submission of a supplemental biologics
license application to the U.S. Food and Drug Administration (FDA) for
every-three-week dosing of Aranesp for the treatment of
chemotherapy-induced anemia in patients with non-myeloid malignancies.
About Chemotherapy-Induced Anemia
Chemotherapy can reduce the bone marrow's ability to produce red
blood cells that transport oxygen from the lungs to all of the body's
muscles and organs. Anemia occurs when there are too few red blood
cells and the body's tissues are "starved" of oxygen, which can make a
patient feel short of breath, very weak, faint and tired.
This year, an estimated 1.3 million cancer patients will undergo
chemotherapy in the United States; approximately 800,000 (67 percent)
will become anemic. More than half of these patients report that
fatigue associated with anemia affects their daily lives more than any
other side effect of treatment, including nausea, pain and depression.
Although anemia is a common and often debilitating side effect of
chemotherapy, it is often not recognized and frequently under-treated.
In fact, 42 percent of patients with a hemoglobin level less than the
recommended target level of 11 g/dL in the National Comprehensive
Cancer Network(R) (NCCN) guidelines for "Cancer and Treatment-Related
Anemia" are never treated with erythropoietic therapy.
Aranesp is a recombinant erythropoietic protein (a protein that
stimulates production of oxygen-carrying red blood cells). Amgen
revolutionized anemia treatment with the development of recombinant
erythropoietin, Epoetin alfa, which is currently marketed in the U.S.
by Amgen as EPOGEN(R) (Epoetin alfa)(i) and by Ortho Biotech Products,
L.P., as Procrit(R) (Epoetin alfa)(ii). Building on this heritage,
Amgen developed Aranesp, a unique erythropoiesis stimulating protein,
which contains two additional sialic acid-containing carbohydrate
chains than the Epoetin alfa molecule and remains in the bloodstream
longer than Epoetin alfa because it has a longer half-life. By virtue
of its longer half-life, Aranesp should be administered less
frequently than Epoetin alfa in patients with chronic kidney disease
Aranesp is approved for multiple indications with varying dosage
instructions in the U.S., European Union, Canada and Australia.
Aranesp was approved by the FDA in September 2001 for up to
every-two-week dosing for the treatment of anemia associated with
chronic renal failure, also known as CKD, for patients on dialysis and
patients not on dialysis. In July 2002, Aranesp was approved by the
FDA for weekly dosing for the treatment of chemotherapy-induced anemia
in patients with non-myeloid malignancies. In 2004, the European
Committee for Medicinal Products for Human Use approved Aranesp for
extended dosing intervals of once every three weeks in the treatment
of anemia in adult cancer patients with non-myeloid malignancies who
are receiving chemotherapy and monthly in the treatment of anemia
associated with CKD.
Important Safety Information
Aranesp is contraindicated in patients with uncontrolled
hypertension. Erythropoietic therapies may increase the risk of
thrombotic events, and other serious events. The target hemoglobin
(Hb) should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in
any two-week period, dose reductions are recommended. In a study with
another erythropoietic product, where the target Hb was 12-14 g/dL, an
increased incidence of thrombotic events, disease progression and
mortality was seen.
Pure red cell aplasia (PRCA) has been observed in patients treated
with recombinant erythropoietins. This has been reported predominantly
in patients with chronic renal failure. Aranesp should be discontinued
in any patient with evidence of PRCA and the patient evaluated for the
presence of antibodies to erythropoietin products. The most commonly
reported side effects in clinical trials were fatigue, edema, nausea,
vomiting, diarrhea, fever and dyspnea.
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Aranesp prescribing information can be accessed by calling
800-772-6436 or by logging on to www.aranesp.com.
(i) Epogen(R) is a registered trademark of Amgen Inc.
(ii) Procrit(R) is a registered trademark of Ortho Biotech
Trish Hawkins, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)
SOURCE: Amgen Inc.