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Biotech / Medical : Biotech success, 2002 -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (7)	1/24/2002 1:45:44 AM
From: Miljenko Zuanic	Respond to of 117

Wednesday January 23, 5:10 pm Eastern Time Press Release SOURCE: Genentech New England Journal of Medicine Study Shows 53 Percent Increase in Event-Free Survival in Patients Treated With Rituxan and CHOP Chemotherapy SOUTH SAN FRANCISCO/SAN DIEGO, Calif. and BASEL, Switzerland--(BW HealthWire)--Jan. 23, 2002-- First improvement in survival over ``gold'' standard chemotherapy seen in 20 years for patients with aggressive Non-Hodgkin's Lymphoma Genentech, Inc. (NYSE: DNA - news), IDEC Pharmaceuticals Corporation (Nasdaq: IDPH - news) 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 GELA Study 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. <snip>