Data Show Improved Response Rate When Zevalin Plus Rituximab Follows Short Course First-Line Treatment in Patients with Follicular Lymphoma



    Data Presented at ASCO Show Increase in Complete Responses

    CHICAGO, June 3 /CNW/ - Biogen Idec (NASDAQ:   BIIB) announced today that
data presented at the 43rd American Society of Clinical Oncology (ASCO) annual
meeting showed that adding Zevalin(R) (Ibritumomab tiuxetan)
radioimmunotherapy to a short course first-line treatment followed by
rituximab weekly for four weeks doubled the rate of complete response in
patients with follicular lymphoma, from 44 percent with a standard treatment
regimen to 88 percent. Additionally, the response rate (complete and partial
responses) for patients in the study was 100 percent based on PET scan
assessment.

    "The increase in complete response rates when adding ZEVALIN
radioimmunotherapy is promising," said Samuel A. Jacobs, M.D., associate
director for clinical investigations at the University of Pittsburgh Cancer
Institute and UPMC Cancer Centers. "These data add to the growing body of
evidence that using radioimmunotherapy as part of front-line treatment may
increase complete response rates."

    About The Trial

    In this Phase II study, patients with symptomatic, stages II-IV and
grades 1-3, untreated follicular lymphoma received three cycles of R-CHOP, a
standard treatment regimen, followed by ZEVALIN. One week after ZEVALIN
treatment, patients received rituximab weekly for four weeks. The primary
endpoint of the trial was complete response rate, which was determined by CT
scan, the conventional methodology, and PET scan. Of 56 evaluable patients, 50
completed both phases of therapy and were evaluated for response.

    Results evaluated by CT scan showed that 44 percent of patients had a
complete response following the R-CHOP phase of treatment. After treatment
with ZEVALIN and extended dose rituximab, complete response rate increased to
88 percent. Results evaluated by PET scan, a newer method of evaluation,
showed a complete response rate of 68 percent with R-CHOP and 96 percent after
treatment with ZEVALIN and extended dose rituximab. The response rate in
patients who completed the treatment regimen was 100 percent based on PET scan
assessment. Median time to progression has not yet been reached; to date, five
patients have experienced disease progression. Adverse events included
myelosuppression and there was one episode of febrile neutropenia after
ZEVALIN and rituximab treatment.

    "We believe that ZEVALIN may play an important role in the treatment of
lymphoma in the front-line setting and are encouraged that data continues to
underscore the impact that radioimmunotherapy can have," said David Parkinson,
M.D., senior vice president, Oncology Research and Development, Biogen Idec.
"In order to further understand the potential of ZEVALIN as a first-line
treatment, we have recently initiated a phase III trial that will evaluate
ZEVALIN as part of first-line treatment with CVP, a commonly-used chemotherapy
regimen."

    ZEVALIN Safety Profile

    Rare deaths have occurred within 24 hours of rituximab (RITUXAN)
infusions. These fatalities were associated with an infusion reaction symptom
complex that included hypoxia, pulmonary infiltrates, acute respiratory
distress syndrome, myocardial infarction, ventricular fibrillation or
cardiogenic shock. Yttrium-90 ZEVALIN administration results in severe and
prolonged cytopenias in most patients. Patients experiencing severe cutaneous
and mucocutaneous reactions should not receive any further components of the
ZEVALIN therapeutic regimen and should seek prompt medical evaluation. In
safety data based upon 349 patients, the most serious adverse reactions of the
ZEVALIN therapeutic regimen were primarily hematologic, with grade 3/4
neutropenia, thrombocytopenia, and anemia occurring in 60 percent, 63 percent
and 17 percent respectively. Infusion-related toxicities were typically grade
1 or 2 and were associated with pre-administration of rituximab. The risk of
hematologic toxicity correlated with the degree of bone marrow involvement
prior to ZEVALIN therapy. Myelodysplastic syndrome (MDS) and/or acute
myelogenous leukemia (AML) were reported in 5.2% (11/211) of patients enrolled
in clinical studies and 1.5% (8/535) of patients included in the
expanded-access trial, with median follow-up of 6.5 and 4.4 years,
respectively. ZEVALIN should only be used by health care professionals
qualified by training and experience in the safe use of radionuclides.

    About ZEVALIN

    On February 19, 2002, the ZEVALIN (Ibritumomab tiuxetan) therapeutic
regimen was approved by the U.S. Food and Drug Administration (FDA) for the
treatment of patients with relapsed or refractory low grade, follicular or
transformed B-cell non Hodgkin's lymphoma (NHL), including patients with
rituximab (RITUXAN) refractory follicular non-Hodgkin's lymphoma.
Determination of the effectiveness of ZEVALIN in a relapsed or refractory
patient population is based on overall response rates. The effects of ZEVALIN
on survival are not known. Radioimmunotherapy offers an option to patients
with certain types of B-cell non-Hodgkin's lymphoma who have failed to
adequately respond to other cancer therapies.

    The ZEVALIN therapeutic regimen combines a monoclonal antibody with a
radioisotope. The monoclonal antibody in ZEVALIN recognizes and attaches to a
particular cell-surface protein on B-cells called the CD20 antigen. This
allows ZEVALIN to specifically target B-cells, destroying malignant NHL
B-cells and also normal B-cells.

    About Biogen Idec

    Biogen Idec creates new standards of care in oncology, neurology and
immunology. As a global leader in the development, manufacturing, and
commercialization of novel therapies, Biogen Idec transforms scientific
discoveries into advances in human healthcare. For ZEVALIN product labeling,
press releases and additional information about the company, please visit
www.biogenidec.com.

    Biogen Idec Safe Harbor

    This press release contains forward-looking statements regarding ZEVALIN
as a treatment for various indications. These statements are based on the
companies' current beliefs and expectation. Drug development involves a high
degree of risk. Factors which could cause actual results to differ materially
from the companies' current expectations include: the risk that unexpected
concerns may arise from additional data or analysis, that regulatory
authorities may require additional information, further studies, or may fail
to approve the drug, or that the company may encounter other unexpected
hurdles. For more detailed information on the risks and uncertainties
associated with Biogen Idec's drug development and other activities, see the
periodic reports of Biogen Idec Inc. filed with the Securities and Exchange
Commission. Biogen Idec assumes no obligation to update any forward-looking
statements, whether as a result of new information, future events or
otherwise.




For further information:

For further information: Biogen Idec Media Contact: Naomi Aoki,
617-679-6284 Director, Public Affairs or Investor Contacts: Eric Hoffman,
617-679-2812 Associate Director, Investor Relations

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