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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,