Monday, Jun 17, 2002
Lugano, Switzerland -- June 17, 2002 --Genentech, Inc. (NYSE: DNA), IDEC Pharmaceuticals Corporation (Nasdaq: IDPH) and Roche today announced initial positive results of a randomized multi-center study evaluating extended therapy with single agent Rituxan® (Rituximab) in patients with both chemotherapy-naïve (front-line) and relapsed indolent non-Hodgkin’s lymphoma (NHL). Professor Michele Ghielmini from the Swiss Group for Clinical Cancer Research (SAKK) discussed the study results during an oral presentation at the Eighth International Conference on Malignant Lymphoma (ICML).
The study enrolled 202 patients of which 188 patients were eligible. At the time of study entry, 59 patients had received no prior therapy and 129 patients had received some form of prior chemotherapy for their NHL. All patients received an induction course of Rituxan (375mg/m2 weekly for 4 weeks). The overall response rate was 66 percent (39/59 patients) for chemotherapy-naïve patients and 46 percent (59/129) for those with relapsed disease.
At week 12, 151 of the 188 patients (80 percent) who achieved either a complete response (CR) or a partial response (PR), or experienced stable disease from the initial course of Rituxan were randomized to receive either extended therapy with Rituxan (one dose 375mg/m2 at month 3,5,7,9 for a total of four doses) or no treatment and were observed. A CR is defined by disappearance of all signs of cancer and a PR is defined as a decrease in tumor size of more than 50 percent.
After a median of 25 months follow-up, the primary endpoint of event-free survival was 22.4 months in patients receiving extended therapy (n=73) compared to 13.6 months for patients who did not receive extended Rituxan therapy and were observed (n=78). For chemotherapy-naïve patients, event-free survival was 35.6 months for extended Rituxan therapy compared to 18.3 months for those patients who did not receive extended Rituxan therapy. Event-free survival is defined as ongoing survival without events including disease progression or relapse, death or initiation of new alternative treatment.
According to the authors, there was no clinically significant increase in adverse events or infections for patients receiving extended Rituxan therapy compared to the observation control arm. Adverse events in this study were similar to those seen in the pivotal trial of Rituxan (see Rituxan safety information below).
“For this patient group, the risk of relapse is extremely high and with each successive relapse the duration of remission decreases,” said Professor Ghielmini. “Clearly the results of this study are encouraging for people with this form of non-Hodgkin’s lymphoma.”
“We are encouraged with the initial data from this study that both chemotherapy-naïve and relapsed indolent NHL patients had an improvement in the primary endpoint of event-free survival when receiving extended Rituxan therapy compared to observation only,” said Kip Benyunes, M.D. associate director, Medical Affairs at Genentech. “Of note, chemotherapy-naïve patients who received extended therapy had a 100 percent improvement, from 18 to 36 months, in the time to disease progression compared to patients who did not receive additional therapy. Furthermore, large randomized Phase III studies in both indolent and aggressive NHL are being conducted by the U.S. cancer cooperative groups. These ongoing studies will enroll more than 1,000 patients and will provide further data on the potential use of Rituxan as a maintenance therapy in these disease settings.”
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 in the United States as a single-agent treatment for relapsed or refractory low-grade or follicular, CD20 positive, B-cell NHL. More than 250,000 patients have been treated with Rituxan worldwide. 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.
About Non-Hodgkin’s Lymphoma
There are more than 250,000 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.
About Genentech, Roche and IDEC
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Fifteen of the currently approved biotechnology products stem from or are based on Genentech science. Genentech manufactures and commercializes ten 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.
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.
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For more information, please visitwww.rituxan.com.