The Largest Randomized Placebo-Controlled Study to Date for
Neulasta Supports First and Subsequent Cycle Administration
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Dec. 10, 2004--
Amgen Inc. (Nasdaq:AMGN), the world´s largest biotechnology
company, today announced that new data from a Phase 3 study show that
the majority of neutropenic complications occur in the first cycle of
chemotherapy treatment for breast cancer patients who are not
administered Neulasta(R) (pegfilgrastim). The study found that
administering Neulasta beginning in the first and subsequent cycles of
chemotherapy reduced the rate of infection, as manifested by febrile
neutropenia (low white blood cell count with fever), by more than 90
percent. Hospitalization and the use of intravenous anti-infectives in
breast cancer patients were also significantly lower in the group
receiving Neulasta in the first and subsequent cycles of chemotherapy.
The results were presented by the study´s lead investigator, Charles
Vogel, M.D., Cancer Research Network, Plantation, Fla., at the 27th
Annual San Antonio Breast Cancer Symposium (SABCS). (SABCS Abstract
"Patients in the placebo arm not only experienced significantly
more neutropenic events than patients in the Neulasta arm, but more
than 65 percent of these events occurred in the first cycle of
treatment, emphasizing the importance of early protection," said Dr.
Vogel. "This study suggests that Neulasta used in first and subsequent
cycles of chemotherapy achieves maximum clinical benefit."
Febrile (or feverish) neutropenia is the most common presentation
of infection in patients receiving chemotherapy. Infection in this
setting can be serious and even life threatening because chemotherapy
can compromise the patient´s ability to fight infection.
Breast cancer patients (Stage 1-4, ECOG performance of 0-2)
receiving 100 mg/m(2) docetaxel every three weeks for up to four
cycles were randomized to receive either 6 mg Neulasta (n=463) or
placebo (n=465) once-per-cycle on the day after docetaxel
administration for up to four cycles. Docetaxel is associated with an
average reported febrile neutropenia incidence of approximately 10 to
20 percent in the absence of growth factor support. Febrile
neutropenia was defined as fever with a temperature equal to or
greater than 38.2 degrees C and an absolute neutrophil count (ANC)
less than 0.5 x 10(9)/L measured the same day or the day after fever
First-cycle administration of Neulasta resulted in a 91 percent
reduction in the incidence of febrile neutropenia occurring in the
first cycle of chemotherapy; an 89 percent reduction in the incidence
of hospitalization and an 83 percent reduction in the incidence of
intravenous anti-infective use.
Specifically, in the first cycle, one percent of patients in the
Neulasta arm (2/463) developed febrile neutropenia compared with 11
percent of patients in the placebo arm (52/465). Neulasta was also
associated with a significantly lower incidence of hospitalizations
with one percent of patients requiring hospitalization (5/463) in the
first cycle versus nine percent of patients receiving placebo
(43/465). One percent of patients in the Neulasta arm (5/463) required
intravenous anti-infectives in the first cycle versus six percent of
patients in the placebo arm (30/465).
In addition, in cycles two through four, less than one percent of
patients in the Neulasta arm (1/458) developed febrile neutropenia
compared with six percent of patients in the placebo arm (26/454).
During these cycles, less than one percent of patients in the Neulasta
arm (1/458) were hospitalized versus five percent in the placebo arm
(21/454). Less than one percent of patients in the Neulasta arm
(3/458) required intravenous anti-infectives in the subsequent cycles
compared to four percent in the placebo arm (19/454).
Neulasta was well tolerated in this study with an adverse event
profile similar to placebo. Bone pain was a frequently observed
adverse event in both arms of the study (31 percent with Neulasta
versus 27 percent with placebo).
Neulasta was approved by the U.S. Food and Drug Administration
(FDA) in 2002 for decreasing the incidence of infection, as manifested
by neutropenia, in patients with nonmyeloid malignancies receiving
myelosuppressive anticancer drugs associated with a clinically
significant incidence of febrile neutropenia. Similar indications for
Neulasta were approved in Europe and Australia the same year.
Rare cases of splenic rupture and sickle cell crises have been
reported in postmarketing experience. Allergic reactions, including
anaphylaxis, have also been reported. The majority of these reactions
occurred upon initial exposure. However, in rare cases, allergic
reactions, including anaphylaxis, recurred within days after
discontinuing anti-allergic treatment. In clinical trials, the only
serious adverse event not attributed to the underlying disease or
chemotherapy was a case of hypoxia. The most common adverse event
attributed to Neulasta was bone pain, reported in 26 percent of
patients. While not reported in patients receiving Neulasta, rare
events of adult respiratory distress syndrome have been reported in
patients receiving the parent compound, Filgrastim.
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SOURCE: Amgen Inc.