Corixa and GlaxoSmithKline Announce Results of Two Studies of BEXXAR(R) Following Chemotherapy as First-Line Treatment of Non-Ho
June 07 2004 - 8:00AM
PR Newswire (US)
Corixa and GlaxoSmithKline Announce Results of Two Studies of
BEXXAR(R) Following Chemotherapy as First-Line Treatment of
Non-Hodgkin's Lymphoma Presented At ASCO NEW ORLEANS, June 7
/PRNewswire-FirstCall/ -- Therapy with two different standard
chemotherapeutic regimens, each followed by a single treatment with
the BEXXAR(R) therapeutic regimen (Tositumomab and Iodine I 131
Tositumomab), produced complete responses in 80-83 percent of
patients as initial treatment for advanced follicular B-cell
non-Hodgkin's lymphoma, according to research presented at the 40th
annual meeting of the American Society of Clinical Oncology (ASCO).
In the first study, investigators reported that 72 percent of
patients who received sequential therapy with fludarabine and
BEXXAR and achieved a complete response remained disease free after
a median follow-up of nearly four and a half years (ASCO Abstract
6518). In a second study, the chemotherapy regimen CVP followed by
BEXXAR produced a complete response rate of 80 percent, with 77
percent of patients continuing in response after a median follow-up
of 2.3 years (ASCO Abstract 6520). "These data contribute to our
growing picture of the utility of BEXXAR in the treatment of
non-Hodgkin's lymphoma, particularly its ability to produce durable
remissions in some patients with advanced disease," said John P.
Leonard, M.D., Clinical Director, Center for Lymphoma and Myeloma,
Weill Medical College of Cornell University, New York. The BEXXAR
therapeutic regimen is indicated for the treatment of patients with
CD20 positive, follicular, non-Hodgkin's lymphoma, with and without
transformation, whose disease is refractory to the antibody
treatment Rituximab and has relapsed following chemotherapy. The
BEXXAR therapeutic regimen is not indicated for the initial
treatment of patients with CD20 positive non-Hodgkin's lymphoma.
The BEXXAR therapeutic regimen is intended as a single course of
treatment. The safety of multiple courses of the BEXXAR therapeutic
regimen, or combination of this regimen with other forms or
irradiation or chemotherapy, has not been evaluated.
Fludarabine/BEXXAR Sequential Therapy Produced Durable Remissions
Dr. Leonard reported long-term follow-up data on 35 patients who
received three cycles of fludarabine followed by the BEXXAR
therapeutic regimen between August 1998 and June 1999 for
previously untreated, advanced, low-grade non- Hodgkin's lymphoma.
At the time of enrollment, 97 percent of patients had stage III/IV
disease. Response to fludarabine was 89 percent (9 percent complete
responses, 80 percent partial responses). After completion of
fludarabine/BEXXAR, all subjects (100 percent) had a response,
including 83 percent with a complete response and 17 percent with a
partial response. With a median follow-up of 4.4 years, median
progression-free survival has not been reached, and 72 percent of
patients (25) who achieved a complete response remain in remission
(range 1.3 to 5.0 years). "We were pleased to observe that the
complete responses achieved by a majority of patients following
fludarabine/BEXXAR have persisted over time," said Dr. Leonard. The
principal adverse event associated with the sequential therapy was
significant depression of blood counts, with grade 4 neutropenia,
thrombocytopenia, and anemia noted in 34 percent, 29 percent and 3
percent of patients, respectively. Sixteen patients (46 percent)
received growth factors or transfusions but there were no serious
infections. Four patients (12 percent) developed elevated thyroid
stimulating hormone (TSH) levels and two (6 percent) became
positive for human anti-mouse antibody (HAMA). After a median
follow-up of 4.4 years, none of the patients have developed
secondary cancers, such as MDS or AML. The Majority of Patients
Achieved Complete Response to CVP/BEXXAR Therapy Data were also
reported from a Phase II, open-label, multicenter study in which 30
patients with previously untreated follicular non-Hodgkin's
lymphoma received six cycles of CVP (cyclophosphamide, vincristine,
and prednisone) followed by the BEXXAR therapeutic regimen.
Enrolled patients ranged in age from 34 to 72 years (median 52
years). Ninety-seven percent had stage III or stage IV disease and
half had a maximum tumor diameter of 5 cm or greater. Following CVP
therapy, 100 percent of patients had a response (50 percent
complete response, 50 percent partial response). After completion
of CVP/BEXXAR, the proportion of patients achieving a complete
response increased from 50 percent to 80 percent. With a median
follow-up of 2.3 years from initiation of therapy, the median
progression-free survival has not been reached and 77 percent (23
patients) continue in response (range 0.6 to 3.4 years).
"CVP/BEXXAR appears to be a regimen with clinical activity for
patients with previously untreated, advanced-stage, follicular
non-Hodgkin's lymphoma and warrants further evaluation in larger
trials," said Brian Link, M.D., Associate Professor of Medicine,
University of Iowa Hospitals and Clinics. "This is one of several
presentations at this meeting suggesting that the use of newer
agents in regimens to treat follicular lymphoma can frequently
result in long remissions without using an anthracycline. The
significance of this will become a little clearer with longer
follow-up." The investigators reported that following BEXXAR, grade
4 neutropenia and thrombocytopenia occurred in 33 percent and 23
percent of patients, respectively. There were no serious infections
and no cases of conversion to HAMA positivity were reported. One
patient developed AML. About the BEXXAR Therapeutic Regimen BEXXAR
pairs the targeting ability of a monoclonal antibody (Tositumomab)
and the therapeutic potential of radiation (Iodine-131). Combined,
these agents form a radiolabeled monoclonal antibody regimen that
is able to bind to the target antigen CD20 found on B-cells,
including normal cells and those that become cancerous in
non-Hodgkin's lymphoma, thereby delivering the dose of radiation.
BEXXAR, which is given in four visits over one to two weeks, is
specifically dosed based on an individual's drug clearance rate,
allowing the delivery of a pre-determined amount of radiation to
each patient. The BEXXAR therapeutic regimen has been studied for
over 13 years. In a multi-center, single-arm, clinical trial in
patients who had received an average of 4 prior chemotherapies and
who had Rituximab-refractory disease (N=35), 63 percent (22 of 35)
responded to BEXXAR. The median duration of response was 25 months.
The results of this study were supported by demonstration of
durable objective responses in four single-arm studies enrolling
190 patients evaluable for efficacy with Rituximab-naove,
follicular non-Hodgkin's lymphoma with or without transformation,
who had relapsed following or were refractory to chemotherapy.
Determination of clinical benefit of the BEXXAR therapeutic regimen
was based on evidence of durable responses without evidence of an
effect on survival. BEXXAR may not be for everyone. Patients who
are pregnant or allergic to any components of the regimen should
not receive BEXXAR. Treatment with BEXXAR resulted in very low
blood counts in the majority of patients, which could be serious,
for an extended period of time (about a month). Infections occurred
in almost half the patients, bleeding in 1 of 8 patients, and
treatment with supportive care in about 1 of 4 patients. Allergic
reactions, including anaphylaxis, which may be severe, have
occurred in patients receiving BEXXAR. Other less severe reactions
during or following the infusion have included fever, chills,
sweating, nausea, low blood pressure, shortness of breath and
trouble breathing. Patients may also experience weakness, fever,
nausea, increased cough, infection, pain, chills, rash, or
headache. There is a risk of hypothyroidism following the
administration of BEXXAR. Administration of BEXXAR resulted in the
development of antibodies to the mouse antibody (called HAMA).
Certain cancer therapies including BEXXAR have been associated with
the development of a second type of blood cancer and solid tumors.
Thirty-two cases (3.2 percent) of myelodysplastic syndrome (a type
of pre-leukemia) and/or leukemia and 52 cases of secondary tumors
were reported in 995 patients enrolled in BEXXAR studies. After
being treated with BEXXAR, less than 5 percent of patients suffered
hair loss or developed severe nausea, vomiting or mucositis (sores
in mouth or gastrointestinal tract). Healthcare providers must be
specifically trained to administer BEXXAR. BEXXAR was developed by
Corixa Corporation and is co-marketed in the United States by
Corixa Corporation and GlaxoSmithKline. Additional information
about the BEXXAR therapeutic regimen, including complete
prescribing information, may be obtained by calling 1-877-4BEXXAR
or visiting http://www.bexxar.com/. About Corixa Corixa
(NASDAQ:CRXA) is a developer of immunotherapeutics with a
commitment to treating and preventing cancer and infectious
diseases by understanding and directing the immune system. On June
30, 2003, Corixa announced that the FDA approved BEXXAR for the
treatment of patients with CD20 positive, follicular, NHL, with and
without transformation, whose disease is refractory to Rituximab
and has relapsed following chemotherapy. Corixa is focused on
immunotherapeutic products and has a broad technology platform
enabling both fully integrated vaccine design and the use of its
separate, proprietary product components on a standalone basis. In
addition to BEXXAR, Corixa currently has multiple programs in
clinical development, including several product candidates that
have advanced to and through late stage clinical trials. The
company partners with numerous developers and marketers of
pharmaceuticals, targeting products that are Powered by Corixa(TM)
technology with the goal of making its potential products available
to patients around the world. Corixa was founded in 1994 and is
headquartered in Seattle, with additional operations in Hamilton,
Mont., and South San Francisco. For more information, please visit
Corixa's Web site at http://www.corixa.com/. About GlaxoSmithKline
GlaxoSmithKline (NYSE:GSK) is one of the world's leading
research-based pharmaceutical and healthcare companies.
GlaxoSmithKline is committed to improving the quality of human life
by enabling cancer patients to do more, feel better and live
longer. For more information, visit http://www.gsk.com/. Corixa
Forward-Looking Statements This press release contains
forward-looking statements, including statements regarding the
prospects for commercialization of BEXXAR and other statements
about our plans, objectives, intentions and expectations. Forward-
looking statements are based on the opinions and estimates of
management at the time the statements are made. They are subject to
certain risks and uncertainties that could cause actual results to
differ materially from any future results, performance or
achievements expressed or implied by such statements. Factors that
could affect Corixa's actual results include, but are not limited
to, the "Factors Affecting Our Operating Results, Our Business and
Our Stock Price," described in our Quarterly Report on Form 10-Q
for the quarter ended March 31, 2004, copies of which are available
from our investor relations department. Readers are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date of this release. GlaxoSmithKline
Forward-Looking Statements Under the safe harbor provisions of the
U.S. Private Securities Litigation Reform Act of 1995, the Company
cautions investors that any forward-looking statements or
projections made by the Company, including those made in this
Announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Factors
that may affect the Group's operations are described under Risk
Factors in the Operating and Financial Review and Prospects in the
Company's Annual Report on Form 20-F for 2003, filed with the U.S.
Securities and Exchange Commission. DATASOURCE: GlaxoSmithKline
CONTACT: Jim DeNike of Corixa Corporation, +1-206-754-5716, ; or
Danielle Halstrom of GlaxoSmithKline, or +1-919-483-2839, ; or
Laura Liotta of Sam Brown Inc., +1-610-353-4545,
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