Sunday, Dec 7, 2003
South San Francisco, Calif. and Cambridge, Mass. -- December 7, 2003 --Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) have been informed that a large, Phase III (MInT) randomized study, evaluating Rituxan® (Rituximab) in combination with chemotherapy as a front-line treatment for aggressive lymphoma has met its pre-specified primary efficacy endpoint early. A pre-planned interim analysis of the study data by an independent Data and Safety Monitoring Committee (DSMC) demonstrated a statistically significant improvement in time to treatment failure (TTF) for patients receiving Rituxan and chemotherapy compared to chemotherapy alone. Based on the analysis, the DSMC has stopped further randomization of patients on this study. The study enrolled approximately 800 patients and was conducted in 18 countries worldwide.
"We are particularly excited about these data as this is the first Rituxan-chemotherapy study in aggressive NHL to include patients younger than 60," said Gwen Fyfe, M.D., Genentech's vice president Clinical Hematology/Oncology. "This is now the third, large, randomized trial of Rituxan in newly diagnosed aggressive NHL and, as such, these data will be an important addition to the data from the Phase III GELA and ECOG 4494 studies of Rituxan in combination with chemotherapy for the treatment of newly diagnosed aggressive lymphoma. We look forward to seeing these data presented in a peer-reviewed forum."
The MabThera International Trial (MInT) was conducted by an international cooperative group and sponsored by Roche. Rituxan is known as MabThera outside the United States. The study enrolled patients age 18 to 60 with large, B-cell, aggressive NHL who had received no previous treatment. Patients were randomized to receive six cycles of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) or CHOP-like chemotherapy alone or in combination with six doses of Rituxan (375 mg/m2). The study protocol allowed the treating physician to decide which chemotherapy to give based on the standard regimen in each country. At the time the study was stopped, 326 patients were analyzed for treatment efficacy. In this study, TTF was defined as documented progressive disease, failure to achieve a complete response rate (CR or Cru), relapse or death.
About Non-Hodgkin's Lymphoma
There are more than 300,000 people in the United States with B-cell NHL. Approximately 50 percent have indolent or follicular lymphoma, while the other half are patients with aggressive NHL. Overall, NHL is the second fastest growing cancer in terms of incidence and deaths in the United States and is diagnosed in more than 56,000 men and women each year.
Rituxan Safety Profile
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 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 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. More than 300,000 patients have been treated with Rituxan worldwide.
Genentech and Biogen Idec co-market Rituxan in the United States, Roche markets Rituxan in the rest of the world, except Japan where Rituxan is co-marketed by Roche and Zenyaku Kogyo Co. Ltd.
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.