New Data Show Improved Outcomes in Certain Lymphomas With ZEVALIN(R) Radioimmunotherapy.ATLANTA -- Abstracts Presented at ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company Annual Meeting Explore Use of ZEVALIN in First-Line Therapy, Retreatment and Transplant Combinations Biogen Idec Inc. (Nasdaq:BIIB BIIB Basic Imagery Interpretation Brief ) and Schering AG, Germany (FSE FSE 1. feline spongiform encephalopathy. 2. focal symmetrical encephalomalacia. :SCH SCH School SCH Schedule SCH Search SCH Semester Credit Hours SCH Santander Central Hispano (bank in Spain) SCH Socket Head SCH Synchronization Channel SCH Succinylcholine SCH Space Center Houston ) (NYSE NYSE See: New York Stock Exchange :SHR SHR Shore SHR Spontaneously Hypertensive Rat SHR Staff Human Resources SHR Saskatoon Health Region (Saskatoon, SK, Canada) SHR Shift Logical Right SHR Sensible Heat Ratio SHR Supplementary Homicide Report SHR Steroid Hormone Receptor ) announced new data presented this week at the 42nd American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO) Annual Meeting in Atlanta, Ga., showing that lymphoma patients with refractory and hard-to-treat disease -- specifically mantle cell lymphoma Mantle cell lymphoma (MCL) is one of the rarer of the non-Hodgkin's lymphomas, comprising about 6% of NHL cases.[1] There are only about 15,000 patients presently in the U.S. (The incidence seems to be somewhat higher in Europe. (MCL MCL - Macintosh Common LISP ), follicular fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ) and primary central nervous system (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ) lymphoma -- experienced improved response and remission rates following administration of ZEVALIN(R) (Ibritumomab Tiuxetan) radioimmunotherapy as consolidation treatment after other, more standard therapies have been given. Additionally, data suggest the use of ZEVALIN as a component of a transplant regimen may reduce patients' risk of relapse. "We are pleased that the data at this year's ASCO meeting continues to explore ZEVALIN's ability to impact a broad range of patients, and underscores the growing role that ZEVALIN can play in the standard of care for lymphoma," said Dr. Wayne Saville, director of Medical Affairs for Biogen Idec. Eleven abstracts were presented on ZEVALIN data. Highlights include the following:
Use of ZEVALIN in MCL and FL Patients
-- First-line consolidation with ZEVALIN in difficult-to-treat
MCL -- Mitchell R. Smith, M.D., Ph.D., lead study investigator
and director of Lymphoma Service, Fox Chase Cancer Center,
presented data from the Eastern Cooperative Oncology Group
Study E1499 on the use of ZEVALIN following administration of
R-CHOP in previously untreated patients with stage II-IV MCL.
The study was designed to evaluate response and toxicity, with
a primary endpoint of time-to-treatment failure.
After four cycles of R-CHOP, seven of the 50 evaluable
patients in the study (14 percent) achieved a complete
response (CR/CRu) and 29 (58 percent) achieved a partial
response. Following treatment with ZEVALIN, responses improved
in 15 of 37 patients. Twelve of the patients with a partial
response exhibited a complete response after ZEVALIN, two
patients with stable disease exhibited a partial response, and
one patient moved from stable disease to a complete response.
The final response rate following ZEVALIN administration was
84 percent, with a complete response rate of 45 percent, more
than triple the rate following R-CHOP alone.
-- ZEVALIN as part of consolidation therapy in MCL -- Oliver
Weigert, M.D., University Hospital Grosshadern/LMU, Munich,
Germany, presented data from two Phase 2 trials of patients
with relapsed or refractory MCL. Twenty-two patients were
evaluated to identify predictors or response. Seven of 14
patients with residual tumor burden after cytoreduction
converted from partial to complete remission following
administration of ZEVALIN, and 14 of the 16 evaluable patients
receiving consolidation ZEVALIN therapy were in remission.
Bulky disease before ZEVALIN therapy was the most prominent
adverse risk factor with no response in these patients.
Patients with fewer prior therapies (less than 2) had
significantly higher response rates.
-- Predictive value of 111In and PET-CT scans during ZEVALIN
consolidation in Follicular Lymphoma (FL) -- Nicholas A.
DeMonaco, M.D., University of Pittsburgh, presented data from
an ongoing Phase 2 trial for the predictive value of 111In
scans and PET/CT results. The proportion of patients with a
negative PET scan was eight of 15 (53.3 percent) after CHOP-R
compared with 100 percent after ZEVALIN was added. Using IWG
criteria in combination with PET scan results, the complete
response rate increased from 26.7 percent after CHOP-R to 80
percent after ZEVALIN. There was no difference in the complete
response rate in patients tumor uptake by 111In scan and those
with a negative 111In scan. Data from this trial suggest that
functional imaging with PET-CT may be a more sensitive method
than CT alone in determining residual disease in follicular
lymphoma (FL).
ZEVALIN with ASCT or PBSC
-- Evaluation of dose escalation with ZEVALIN in ASCT -- Ian W.
Flinn, M.D., Johns Hopkins Oncology Center, presented
preliminary data of patients with relapsed or refractory
low-grade mantle cell or diffuse B-Cell NHL when ZEVALIN was
administered with autologous stem cell transplantation (ASCT).
-- Evaluation of ZEVALIN in NHL -- Avichai Shimoni, M.D., Chaim
Sheba Medical Center, Tel Aviv, Israel, presented preliminary
data regarding administration of ZEVALIN and high-dose
chemotherapy prior to ASCT in chemo-refractory aggressive NHL.
-- High dose ZEVALIN in heavily pre-treated NHL patients -- Anna
Vanazzi, M.D., European Institute of Oncology, Milan, Italy,
presented preliminary data from a Phase 1/2 trial evaluating
ZEVALIN with peripheral blood stem cell support (PBSC).
Additional ZEVALIN Abstracts
-- Retreatment with ZEVALIN in patients with follicular NHL --
Andres Forero, M.D., Comprehensive Cancer Center, UAB Health
System, presented the first safety and efficacy data related
to treating follicular NHL with a second course of ZEVALIN.
-- ZEVALIN in combination with gemcitabine -- Hossein Borghaei,
D.O., Fox Chase Cancer Center, presented preliminary data from
a Phase 1 trial designed to assess the safety of concomitant
administration of ZEVALIN with gemcitabine in patients with
NHL.
-- ZEVALIN in PCNSL -- Philipp Kiewe, M.D., Charite Campus
Benjamin Franklin, Berlin, Germany, offered preliminary data
on treatment with ZEVALIN in previously-treated patients with
primary CNS lymphoma (PCNSL).
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 hypoxia Condition in which tissues are starved of oxygen. The extreme is anoxia (absence of oxygen). There are four types: hypoxemic, from low blood oxygen content (e.g., in altitude sickness); anemic, from low blood oxygen-carrying capacity (e.g. , pulmonary infiltrates, acute respiratory distress syndrome acute respiratory distress syndrome n. See adult 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 cutaneous /cu·ta·ne·ous/ (ku-ta´ne-us) pertaining to the skin. cu·ta·ne·ous adj. Of, relating to, or affecting the skin. Cutaneous Pertaining to the skin. and mucocutaneous mucocutaneous /mu·co·cu·ta·ne·ous/ (-ku-ta´ne-us) pertaining to or affecting the mucous membrane and the skin. mu·co·cu·ta·ne·ous adj. Of or relating to the skin and a mucous membrane. 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 hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. , with grade 3/4 neutropenia Neutropenia Definition Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells (WBCs) produced in the bone marrow that ingest bacteria. , thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. , 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. Myelodysplasia or acute myelogenous leukemia acute myelogenous leukemia n. Abbr. AML Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. was observed in 2 percent of patients (8 to 34 months after treatment). 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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 radioisotope: see radioactive isotope. Radioisotope (biology) A radioactive isotope used in studying living systems, such as in the investigation of metabolic processes. . 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 Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given 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 http://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. About Schering AG Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Gynecology&Andrology, Oncology, Diagnostic Imaging as well as Specialized Therapeutics for disabling diseases. As a global player with innovative products Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life: making medicine work. |
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