Journal of Clinical Oncology Publishes TREANDA Study Demonstrating Significant Improvement in Overall Response and Progression-Free Survival in Chronic Lymphocytic Leukemia
FRAZER, Pa., Aug. 3 /PRNewswire-FirstCall/ -- Cephalon, Inc.
(NASDAQ: CEPH) today announced that the Journal
of Clinical Oncology has published data from a pivotal phase 3
study demonstrating that TREANDA (bendamustine HCl) for Injection
improved clinical outcomes when compared to chlorambucil in
patients with chronic lymphocytic leukemia (CLL). Results of this
study were the basis of the March 2008 U.S. Food and Drug
Administration (FDA) approval of TREANDA for CLL, the first agent
approved by the FDA for this disease since 2001. According to the
American Cancer Society, there will be more than 15,000 new cases
of CLL diagnosed in 2009 alone. The study results were published
online today and will also appear in the print edition later this
year.
This Phase 3, randomized, international, multicenter, open-label
study evaluated the efficacy and safety of TREANDA compared to
chlorambucil in previously untreated patients with advanced (Binet
stage B-C) CLL. Patients received TREANDA (100 mg per square meter
on days 1 and 2) (n=162) or chlorambucil (0.8 mg/kg on days 1 and
15) (n=157) for up to six treatment cycles. In this study, TREANDA
demonstrated significantly better outcomes for both primary
endpoints compared to chlorambucil: overall response rate and
progression-free survival (PFS).The overall response rate was
significantly higher in patients receiving TREANDA than
chlorambucil (68% vs. 31%; p<0.0001). Patients in the TREANDA
treatment arm also had a higher complete response rate than those
treated with chlorambucil (31% vs. 2%) which means that after
treatment with TREANDA, some patients had no signs of CLL in their
blood.
"CLL is the most common form of adult leukemia in the Western
world. Because it is incurable, the goal of treatment is to
stabilize the cancer over the long-term by extending periods of
remission," said Prof. Wolfgang Knauf, Onkologische
Gemeinschaftspraxis, Frankfurt, Germany and lead investigator of
this study. "Treatment options are limited for those with advanced
CLL, but this study shows that bendamustine demonstrates
significantly better efficacy compared to chlorambucil with a
tolerable safety profile."
The study also showed that patients treated with TREANDA had
significantly longer PFS compared to chlorambucil (median PFS 21.6
months vs. 8.3 months; p<0.0001). TREANDA was also associated
with an improvement in duration of response compared to
chlorambucil (21.8 months vs. 8 months). In the study, TREANDA
demonstrated a tolerable safety profile; the most common adverse
events included myelosuppression, fever, nausea, vomiting and
diarrhea. The Clinical Studies section of the TREANDA prescribing
information includes complete FDA-approved study information.
About TREANDA
TREANDA, a novel chemotherapy, was approved by the FDA for the
treatment of CLL in March 2008. Efficacy relative to other first
line therapies other than chlorambucil has not been established.
TREANDA received its second approval in October 2008 for the
treatment of patients with indolent B-cell non-Hodgkin's lymphoma
(NHL) that has progressed during or within six months of treatment
with rituximab or a rituximab-containing regimen.
The following serious adverse reactions have been associated
with TREANDA in clinical trials: myelosuppression, infections,
infusion reactions and anaphylaxis, tumor lysis syndrome, skin
reactions, and other malignancies.
TREANDA has a unique chemical structure that is synthesized to
combine an alkylating group and a purine-like benzimidazole
component. Though the exact mechanism of action of TREANDA remains
unknown, TREANDA may act in two distinct ways to kill cancer cells.
Preclinical studies suggest that TREANDA may lead to cell death by
a process known as apoptosis (programmed cell death) as well as by
an alternate cell death pathway which disrupts normal cell division
known as mitotic catastrophe (a non-apoptotic pathway).
Cephalon holds exclusive rights to market and develop TREANDA in
the United States. TREANDA is licensed from Astellas Deutschland
GmbH. Bendamustine HCl, the active ingredient in TREANDA, is
marketed in Germany by Astellas' licensee, Mundipharma
International Corporation Limited. In Germany, bendamustine is
indicated as a single-agent or in combination with other
anti-cancer agents for indolent NHL, multiple myeloma, and CLL.
SymBio Pharmaceuticals Ltd holds exclusive rights to develop and
market bendamustine HCl in Japan and select Asia Pacific Rim
countries.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international
biopharmaceutical company dedicated to the discovery, development
and commercialization of many unique products in four core
therapeutic areas: central nervous system, inflammatory diseases,
pain and oncology. A member of the Fortune 1000 and the S&P 500
Index, Cephalon currently employs approximately 3,000 people in the
United States and Europe. U.S. sites include the company's
headquarters in Frazer, Pennsylvania, and offices, laboratories or
manufacturing facilities in West Chester, Pennsylvania, Salt Lake
City, Utah, and suburban Minneapolis, Minnesota.
Cephalon has a growing presence in Europe, the Middle East and
Africa. The Cephalon European headquarters and pre-clinical
development center are located in Maisons-Alfort, France, just
outside of Paris. Key business units are located in England,
Ireland, France, Germany, Italy, Spain, the Netherlands for the
Benelux countries, and Poland for Eastern and Central European
countries. Cephalon Europe markets more than 30 products in four
areas: central nervous system, pain, primary care and
oncology.
The company's proprietary products in the United States include:
NUVIGIL (armodafinil) Tablets [C-IV], TREANDA, AMRIX
(cyclobenzaprine hydrochloride extended-release capsules), FENTORA
(fentanyl buccal tablet) [C-II], TRISENOX, GABITRIL (tiagabine
hydrochloride), PROVIGIL (modafinil) Tablets [C-IV] and ACTIQ (oral
transmucosal fentanyl citrate) [C-II]. The company also markets
numerous products internationally. Full prescribing information on
its U.S. products is available at http://www.cephalon.com/ or by calling
1-800-896-5855.
In addition to historical facts or statements of current
condition, this press release may contain forward-looking
statements. Forward-looking statements provide Cephalon's current
expectations or forecasts of future events. These may include
statements regarding anticipated scientific progress on its
research programs, development of potential pharmaceutical
products, interpretation of clinical results, prospects for
regulatory approval, manufacturing development and capabilities,
market prospects for its products, sales and earnings guidance, and
other statements regarding matters that are not historical facts.
You may identify some of these forward-looking statements by the
use of words in the statements such as "anticipate," "estimate,"
"expect," "project," "intend," "plan," "believe" or other words and
terms of similar meaning. Cephalon's performance and financial
results could differ materially from those reflected in these
forward-looking statements due to general financial, economic,
regulatory and political conditions affecting the biotechnology and
pharmaceutical industries as well as more specific risks and
uncertainties facing Cephalon such as those set forth in its
reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities
and Exchange Commission. Given these risks and uncertainties, any
or all of these forward-looking statements may prove to be
incorrect. Therefore, you should not rely on any such factors or
forward-looking statements. Furthermore, Cephalon does not intend
to update publicly any forward-looking statement, except as
required by law. The Private Securities Litigation Reform Act of
1995 permits this discussion.
Media: Investors: Jenifer Antonacci Robert (Chip) Merritt 610-738-6674 610-738-6376 jantonacci@cephalon.com cmerritt@cephalon.com
Source: Cephalon, Inc.
CONTACT: Media: Jenifer Antonacci, +1-610-738-6674,
jantonacci@cephalon.com; or
Investors: Robert (Chip) Merritt, +1-610-738-6376,
cmerritt@cephalon.com, both of
Cephalon, Inc.
Web Site: http://www.cephalon.com/
Posted: August 2009
