Wednesday, Jan 23, 2002
South San Francisco and San Diego, Calif. and Basel, Switerland -- January 23, 2002 --Genentech, Inc. (NYSE: DNA), IDEC Pharmaceuticals Corporation (Nasdaq: IDPH) and Roche today announced the results of a study published in the New England Journal of Medicine that shows 13 percent (23 percent relative increase) more patients were alive two years following treatment for aggressive non-Hodgkin's lymphoma (NHL) when Rituxan®/MabThera® (Rituximab) was added to standard CHOP (cyclophosphamide, doxorubicin, vinicristine and prednisone) chemotherapy, compared to those patients treated with CHOP alone. CHOP chemotherapy is considered the standard of care for aggressive NHL with a 30 to 40 percent cure rate.
The findings are based on two-year follow-up data from a 399-patient (age 60-80 years) Phase III study conducted by Groupe d'Etude des Lymphomes de l'Adulte (GELA). After median follow-up of two years, a significant improvement was seen in the primary endpoint of event-free survival, from 37 percent (75/197 patients) with CHOP alone to 57 percent (115/202 patients) in the Rituxan/CHOP arm an absolute increase of 20 percent (53 percent relative increase). Event-free survival was defined as ongoing survival without events including disease progression or relapse, death or initiation of new alternative treatment.
Overall survival was increased from 57 percent (112/197 patients) in the CHOP alone arm to 70 percent (141/202 patients) in the Rituxan/CHOP arm, an absolute increase of 13 percent (23 percent relative increase). Complete response rate (disappearance of all detectable signs of cancer) increased from 63 percent (124/197 patients) in the CHOP alone arm to 76 percent (154/202 patients) in the Rituxan/CHOP arm, an absolute increase of 13 percent (21 percent relative increase).
"The complete response rates seen with this new combination are very encouraging and indicate a real change in the way this disease potentially can be treated," said lead study investigator Professor Bertrand Coiffier, Head of the Department of Hematology, Hospices Civiles de Lyon, France. "For the first time in 20 years we have a new drug combination that shows an increased chance of improvement in overall survival in this common form of blood cancer."
"Publication of these two-year results from the GELA study in a peer-reviewed publication is an important milestone for Rituxan," said Susan D. Hellmann, M.D., M.P.H., Genentech's executive vice president, Development and Product Operations, and chief medical officer. "These results continue to support the growing body of evidence that Rituxan may be most beneficial when given early in the course of disease treatment to provide durable and sustained responses in patients with NHL."
Rituxan Safety Profile
Approximately 10 percent of patients in the Rituxan/CHOP arm experienced Grade 3/4 infusion-related events. As has been seen in prior studies with Rituxan, these events were generally limited to the first infusion of Rituxan and were reversible. Beyond these first infusion events, the addition of Rituxan to CHOP chemotherapy did not appear to cause a clinically significant increase in adverse events to those seen with CHOP chemotherapy alone.
Post-Marketing Safety Information
The majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include, but are not limited to, flu-like fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema and hypotension. These symptoms vary in severity and generally are reversible with medical intervention. In rare instances, severe and fatal infusion-related reactions have occurred, nearly all of which have been associated with the first Rituxan infusion. These events appear as manifestations of an infusion-related complex and include hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock and tumor lysis syndrome. Patients who develop clinically significant infusion-related cardiopulmonary events should have their Rituxan infusion discontinued and receive medical treatment.
In rare instances, severe mucocutaneous skin reactions have occurred that may be associated with Rituxan therapy. Many of these reactions have been described as paraneoplastic pemphigus and are known to be associated with various B-cell lymphomas, particularly NHL and chronic lymphocytic leukemia (CLL). Patients who develop a severe mucocutaneous skin reaction should have Rituxan discontinued and receive appropriate medical treatment, including a skin biopsy to guide therapy.
Rituxan is a monoclonal antibody that binds to a particular protein -- the CD20 antigen -- on the surface of normal and malignant B-cells. It then recruits the body's natural defenses to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
More than 200,000 patients have been treated with Rituxan worldwide. Rituxan received FDA approval in November 1997 for the treatment of relapsed or refractory low-grade or follicular, CD20 positive, B-cell NHL. It also was approved in the European Union (EU) under the trade name MabThera® in June 1998. Genentech and IDEC co-market Rituxan in the United States, Roche markets Rituxan in the rest of the world, except Japan where Rituxan is co-marketed with Zenyaku Kogyo Co. Ltd.
In October 2001, the European Committee for Proprietary Medicinal Products (CPMP) recommended approval in the EU of MabThera and CHOP for the treatment of aggressive NHL.
About Aggressive NHLApproximately 1.5 million people worldwide are living with various forms of lymphoma, and it is estimated that 300,000 people die each year. In terms of incidence and death, NHL is the second fastest growing cancer in the United States and the third fastest growing in the rest of the world.
Lymphomas generally are classified into two equal groups: half are indolent (low-grade) lymphomas while the remaining are aggressive (intermediate/high-grade). Intermediate/high-grade lymphomas spread rapidly, and left untreated, can be fatal within six months to two years. Patients who are diagnosed and treated in early stages of aggressive disease are more likely to experience a complete remission of several years duration and are less likely to have late recurrences. In contrast, while low-grade lymphomas progress slowly and patients may live an average of six to seven years, the disease remains incurable with therapy.
About Genentech, Roche and IDEC
Genentech, Inc., is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Fifteen of the currently approved products of biotechnology are based on or stem from Genentech science. Genentech markets ten products directly in the United States. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA.
Roche is a world leader in Oncology. Its Franchise includes MabThera (non-Hodgkin?s lymphoma), Xeloda (colorectal cancer, breast cancer), Herceptin (breast cancer), NeoRecormon (anemia in various cancer settings), Roferon-A (leukemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma), Neupogen (neutropenia) and Kytril (chemotherapy and radiotherapy-induced nausea).
IDEC Pharmaceuticals focuses on the commercialization and development of targeted therapies for the treatment of cancer and autoimmune diseases. IDEC's antibody products act chiefly through immune system mechanisms, exerting their effect by binding to specific, readily targeted immune cells in the patient's blood or lymphatic systems. IDEC is headquartered in San Diego, California, and is traded on the NASDAQ National Market System under the stock symbol, IDPH.
For full prescribing information please call (650) 225-8681.
For more information, please visit http://www.rituxan.com.
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