Aranesp(R) ``145 Study'' Shows No Difference in Survival in Patients with Small-Cell Lung Cancer
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--April 19, 2007--Amgen
(NASDAQ: AMGN) today announced the results of the "145 study", a
randomized, double-blind, placebo-controlled, multicenter Phase 3
study of Aranesp(R) (darbepoetin alfa) in 600 previously untreated
patients with extensive-stage small-cell lung cancer (SCLC) receiving
platinum-containing chemotherapy. The study demonstrated no
statistically significant difference in risk of death (overall
survival Aranesp compared to placebo Hazard Ratio (HR): 0.93, 95% CI:
0.78 to 1.11) or investigator determined progression-free survival
(HR: 1.02, 95% CI: 0.86 to 1.21).
The study demonstrated a significant change in hemoglobin
concentration from baseline in favor of Aranesp (a co-primary
endpoint). Aranesp-treated patients also experienced a significantly
lower risk of blood transfusions (HR: 0.40, 95% CI: 0.29 to 0.55). The
overall safety profile, including thromboembolic events, was
consistent with that described in the U.S. label.
"The 145 study is a component of Amgen's ongoing pharmacovigilance
program designed to evaluate the effect of Aranesp on long-term
survival in patients with chemotherapy-induced anemia. This study had
higher initiation and maintenance hemoglobin targets (Hb less than or
equal to 13 g/dl) than in the U.S. label," said Roger M. Perlmutter,
M.D., Ph.D., executive vice president of Research and Development at
Amgen. "These results contribute to the growing body of evidence on
ESA safety, reinforcing the neutral impact of ESAs on survival in
cancer patients suffering from chemotherapy-induced anemia."
Amgen initiated the SCLC study in 2002 after results from a
previous Phase 3 study showed a trend towards improved survival in
patients with lung cancer. The 145 study was designed to evaluate
whether increasing or maintaining hemoglobin concentrations with
Aranesp, when administered with platinum-containing chemotherapy in
patients with previously untreated extensive-stage SCLC, increased
In this study, patients were randomized 1:1 to receive Aranesp 300
mcg or placebo every week (QW) for the first 4 weeks, followed by once
every three week (Q3W) dosing (commencing on week 5) for the remainder
of the 24-week treatment period. Patients were treated to a target Hb
of 13 g/dL, which is higher than indicated by the FDA-approved product
label, with dose withholding at 14 g/dL.
Conference Call Information
Amgen will discuss the results of the 145 study during a
conference call to review the Company's first quarter financial
results with the investment community at 2:00 PM, Pacific Time,
Monday, April 23, 2007. Live audio of the conference call will be
simultaneously broadcast over the Internet and will be available to
members of the news media, investors and the general public. The
conference call, including the question and answer session, is
expected to last approximately one hour.
The webcast of the conference, as with other selected
presentations regarding developments in Amgen's business given by
management at certain investor and medical conferences, can be found
on Amgen's Web site, www.amgen.com, under Investors. Information
regarding presentation times, webcast availability, and webcast links
are noted on Amgen's Investor Relations Events Calendar. The webcast
will be archived and available for replay 72 hours after the event.
Aranesp was approved by the U.S. Food and Drug Administration
(FDA) in September 2001 for the treatment of anemia associated with
chronic renal failure (CRF), also known as chronic kidney disease
(CKD), for patients on dialysis and patients not on dialysis. In July
2002, the FDA approved weekly dosing of Aranesp for the treatment of
anemia in patients with nonmyeloid malignancies where anemia is due to
the effect of concomitantly administered chemotherapy, and in March
2006, the FDA approved every-three-week dosing in these patients.
Important Safety Information including boxed WARNING
Use the lowest dose of Aranesp that will gradually increase the
hemoglobin concentration to the lowest level sufficient to avoid the
need for red blood cell transfusion.
Aranesp and other erythropoiesis-stimulating agents (ESAs)
increased the risk for death and for serious cardiovascular events
when administered to target a hemoglobin of greater than 12 g/dL.
Cancer Patients: Use of ESAs
-- Shortened the time to tumor progression in patients with
advanced head and neck cancer receiving radiation therapy when
administered to target a hemoglobin of greater than 12 g/dL,
-- Shortened overall survival and increased deaths attributed to
disease progression at 4 months in patients with metastatic
breast cancer receiving chemotherapy when administered to
target a hemoglobin of greater than 12 g/dL,
-- Increased the risk of death when administered to target a
hemoglobin of 12 g/dL in patients with active malignant
disease receiving neither chemotherapy or radiation therapy.
ESAs are not indicated for this population.
Patients receiving ESAs pre-operatively for reduction of
allogeneic red blood cell transfusions: A higher incidence of deep
venous thrombosis was documented in patients receiving Epoetin alfa
who were not receiving prophylactic anticoagulation. Aranesp is not
approved for this indication.
Aranesp is contraindicated in patients with uncontrolled
hypertension. Aranesp and other erythropoietic therapies increase the
risk of serious arterial and venous thromboembolic events, including
myocardial infarction, stroke, congestive heart failure, and
hemodialysis graft occlusion. A rate of hemoglobin rise of greater
than 1 g/dL over 2 weeks may also contribute to these risks. To reduce
cardiovascular risks, the hemoglobin (Hb) concentration should not
exceed 12 g/dL, the rate of hemoglobin increase should not exceed 1
g/dL in any 2-week period.
Cases of pure red cell aplasia (PRCA) and of severe anemia, with
or without other cytopenias, associated with neutralizing antibodies
to erythropoietin have been reported in patients treated with Aranesp.
This has been reported predominantly in patients with CRF receiving
Aranesp by subcutaneous administration. A sudden loss of response to
Aranesp, accompanied by severe anemia and low reticulocyte count,
should be evaluated. If anti-erythropoietin antibody-associated anemia
is suspected, withhold Aranesp and other erythropoietic proteins.
Aranesp should be permanently discontinued in patients with
antibody-mediated anemia. Patients should not be switched to other
erythropoietic proteins as antibodies may cross-react.
The most commonly reported side effects in clinical trials in
patients with CRF were infection, hypertension, hypotension, myalgia,
headache, and diarrhea. The most commonly reported side effects in
clinical trials in patients with chemotherapy-induced anemia were
fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.
The Aranesp prescribing information, including important safety
information and boxed warning, may be accessed at www.aranesp.com.
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