Sunday, Dec 7, 2003
San Diego -- December 7, 2003 --Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) today announced initial positive results of the first randomized Phase III trial with Rituxan® (Rituximab) in previously untreated (front-line) patients with indolent non-Hodgkin's lymphoma (NHL).
The results demonstrated that the addition of Rituxan to cyclophosphamide, vincristine, and prednisone chemotherapy (R-CVP) prolonged time to treatment failure (TTF), the primary endpoint of the study, to 26 months compared to seven months for patients treated with CVP alone. The risk of an event (defined as disease progression, relapse, death, stable disease after cycle four or new treatment administered) was reduced by 66 percent in patients who received R-CVP.
This is one of a number of studies to be presented at the American Society of Hematology (ASH) 45th Annual Meeting that demonstrate the potential of adding Rituxan to front-line chemotherapy for patients with indolent NHL. Indolent lymphoma is a slow-growing, incurable disease in which the average patient survives between six and 10 years following numerous periods of remission and relapse.
"These data represent an important potential treatment option for newly diagnosed patients with indolent lymphoma," said Gwen Fyfe, M.D., Genentech's vice president, Clinical Hematology/Oncology. "The long duration of response allows patients with this incurable disease prolonged treatment free and symptom free time."
The data were presented today during an oral presentation by Robert Marcus, M.D., of Addenbrookes Hospital, United Kingdom. The study evaluated 321 patients who had not received previous treatment for stage III/IV CD20-positive follicular or indolent NHL. These patients were randomized to receive either CVP alone (n=159) on a 21-day cycle for eight cycles or CVP chemotherapy with Rituxan (375 mg/m2) (n=162) on the first day of each cycle.
According to the study, patients treated with R-CVP experienced an overall response rate (ORR) of 81 percent (131/162) compared to 57 percent (91/159) for patients treated with CVP alone. The complete response (CR) rate was 41 percent (66/162) in the R-CVP arm compared to 10 percent (16/159) for patients treated with CVP alone. The median time to treatment progression (TTP) for patients treated with R-CVP was 27 months compared to 15 months for those who received CVP alone.
Some patients in the R-CVP group experienced Rituxan-related infusion reactions. There were no differences in infection rates between the two treatment arms and no treatment-related deaths.
Rituxan is a therapeutic 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.
Rituxan is indicated as a single-agent treatment for relapsed or refractory low-grade or follicular, CD20-positive, B-cell NHL. Rituxan is referred to as MabThera outside the United States. More than 300,000 patients have been treated with Rituxan worldwide.
Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets Rituxan in the rest of the world, except Japan where Rituxan is co-marketed by Roche and Zenyaku Kogyo Co. Ltd.
Rituxan Safety Profile
The majority of patients experience infusion-related symptoms with their first infusion. These symptoms vary in severity and generally are reversible with medical intervention. In rare instances, severe and fatal infusion-related reactions Rituxan infusion. These symptoms include but are not limited to, flu-like fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema and 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 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.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Sixteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 12 biotechnology 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. For press releases and additional information about the company, please visit http://www.gene.com.
About Biogen Idec
Biogen Idec creates new standards of care in oncology 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 product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
For full prescribing information, including Boxed Warnings, please call 650-225-5873. For more information on Rituxan, visit http://www.rituxan.com.