Celgene Corporation (NASDAQ: CELG) today announced updated Overall
Survival (OS) results from a post-hoc analysis of its phase III MPACT (Metastatic
Pancreatic Adenocarcinoma Clinical Trial)
study of ABRAXANE® (paclitaxel protein-bound particles for
injectable suspension) (albumin-bound) in combination with gemcitabine
in treatment-naïve patients with metastatic pancreatic cancer. A poster
discussion of the analysis is scheduled for Sunday, June 1st
at 11:30 am CT at the 50th American Society of Clinical
Oncology (ASCO) annual meeting in Chicago, Ill.
The extended data cutoff occurred at final database lock in May 2013 and
allowed for an OS analysis of mature data from 90% of the patients in
the study. The extended analysis showed that ABRAXANE plus gemcitabine
demonstrated an improvement in OS in the intent-to-treat population
compared to patients that received gemcitabine alone [(median OS of 8.7
vs. 6.6. months) (HR0.72, P<0.0001), a difference of 2.1 months]. The
analysis showed survival up to 3.5 years in the ABRAXANE plus
gemcitabine group (3% of patients alive vs 0% with gemcitabine alone).
One- and 2- year survival rates were consistent with the primary
The analysis also showed that the treatment effect on OS for
pre-specified subgroups analyzed in the trial remained consistent across
patient subgroups. Specifically, patients with Karnofsky Performance
Status (KPS) KPS 90-100 had a higher median OS on ABRAXANE plus
gemcitabine as compared to gemcitabine alone [median OS 9.7 months vs.
7.9 months (HR 0.77, P=0.0053)]. Patients with KPS 70-80 also maintained
a benefit [median OS 7.6 months vs. 4.3 months (HR 0.59, P<0.0001)].
This updated analysis also evaluated the prognostic effects of CA19-9
and neutrophil-to-lymphocyte ratio (NLR). Both elevated CA19-9 and
elevated NLR were associated with poorer survival. Further, treatment
with ABRAXANE plus gemcitabine appeared to reduce the effect of CA19-9
as a poor prognostic factor, as similar overall survival was observed
regardless of CA19-9 level.
In the MPACT study, the most common grade = 3 treatment-related adverse
events in the study for ABRAXANE plus gemcitabine vs. gemcitabine alone
were neutropenia, peripheral neuropathy and fatigue. In the ABRAXANE
plus gemcitabine arm 17% of patients had grade 3 peripheral neuropathy
(no cases of grade 4; 54% had any-grade peripheral neuropathy). Seven
percent of patients on the ABRAXANE plus gemcitabine arm that received
the average treatment duration experienced Grade 3 neuropathy. The
median time to improvement of grade 3 peripheral neuropathy to grade = 1
was 29 days, and 44% of patients resumed treatment with ABRAXANE. Grade
= 3 fatigue occurred in 18% of patients. The primary results of the
MPACT study from the pre-specified analysis from September 2012 were
published in the New England Journal of Medicine in the October 31st
Details of the poster presentation at ASCO:
About the MPACT Study
In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical
Trial) study, a Celgene-sponsored, open-label, randomized,
international study, a total of 861 patients were randomized 1:1 (431
patients to the ABRAXANE/gemcitabine group and 430 patients to the
gemcitabine group). The primary endpoint for the study was overall
survival. Secondary endpoints were progression-free survival and overall
response rate determined by independent radiological review. Other
endpoints included progression-free survival and overall response rate
as determined by the investigator, and the safety and tolerability of
the combination in this patient population.
About Pancreatic Cancer
Pancreatic cancer is the fourth-leading cause of cancer-related death in
the U.S. and Europe. The pancreas is composed of two main cell types:
exocrine and endocrine. Adenocarcinoma is a sub-type of exocrine tumors
and accounts for about 95% of cancers of the pancreas. For all stages of
pancreatic cancer combined, the five-year survival rate in U.S. is about
6% and 5.7% in the EU. For metastatic pancreatic cancer, the five-year
survival is approximately 1% in the U.S.
ABRAXANE is an albumin-bound form of paclitaxel that is manufactured
using patented nab® technology. ABRAXANE
is formulated with albumin, a human protein, and is free of solvents.
In September 2013, the U.S. FDA approved ABRAXANE as first-line
treatment of patients with metastatic adenocarcinoma of the pancreas, in
combination with gemcitabine. In December 2013, ABRAXANE in combination
with gemcitabine was approved for first-line treatment of adult patients
with metastatic adenocarcinoma of the pancreas in Europe.
Important Safety Information Based on Approved U.S. Label
WARNING - NEUTROPENIA
Do not administer ABRAXANE therapy to patients who have
baseline neutrophil counts of less than 1500 cells/mm3.
In order to monitor the occurrence of bone marrow suppression,
primarily neutropenia, which may be severe and result in
infection, it is recommended that frequent peripheral blood cell
counts be performed on all patients receiving ABRAXANE
Note: An albumin form of paclitaxel may substantially affect a
drug's functional properties relative to those of drug in
solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL
WARNINGS AND PRECAUTIONS
Use in Pregnancy: Pregnancy Category D
Use in Men
Postmarketing Experience With ABRAXANE and Other Paclitaxel
USE IN SPECIFIC POPULATIONS
DOSAGE AND ADMINISTRATION
Please see full Prescribing Information, including Boxed WARNING at http://abraxane.com/downloads/Abraxane_PrescribingInformation.pdf
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global pharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative therapies for
the treatment of cancer and inflammatory diseases through gene and
protein regulation. For more information, please visit www.celgene.com.
Follow us on Twitter @Celgene as well.
This press release contains forward-looking statements, which are
generally statements that are not historical facts. Forward-looking
statements can be identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans," "will," "outlook" and
similar expressions. Forward-looking statements are based on
management's current plans, estimates, assumptions and projections, and
speak only as of the date they are made. Celgene Corporation undertakes
no obligation to update any forward-looking statement in light of new
information or future events, except as otherwise required by law.
Forward-looking statements involve inherent risks and uncertainties,
most of which are difficult to predict and are generally beyond our
control. Actual results or outcomes may differ materially from those
implied by the forward-looking statements as a result of the impact of a
number of factors, many of which are discussed in more detail in Celgene
Corporation's Annual Report on Form 10-K and its other reports filed
with the Securities and Exchange Commission.
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