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Idiotype Vaccine Therapy in Follicular Lymphoma Demonstrates Improvement in Disease-Free Survival

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Results from the long-awaited randomized phase III study of a personalized vaccine therapy (BiovaxID) in patients with follicular lymphoma was reported by Dr. Steve Schuster of the University of Pennsylvania at ASCO 2009.

This multi-center study, which was originally designed by Dr. Larry Kwak of M. D. Anderson, enrolled 234 patients over seven years. One hundred and seventeen patients who achieved complete remissions after chemotherapy were randomly assigned to receive a vaccine with the cytokine granulocyte macrophage colony stimulating factor (GM-CSF) or placebo vaccine (2 to 1 randomization; 76 vaccine and 41 placebo.

With a median follow-up of 56 months, there was no survival difference between the two treatment arms. However, remarkably, patients who received the vaccine had a 44-month median progression-free survival compared with 30 months for the patients who received a placebo.  

Two previous large phase III studies using idiotype vaccine strategies failed to demonstrate any benefits, making this study the first to demonstrate benefit of vaccine therapy in patients with follicular lymphoma, and provides more encouragement for the vaccine field. 

Dr. Ronald Levy of Stanford University, who discussed the study, pointed out that the different results between the current study and the two other studies from Favrille and Genitope may be related to the differences in study designs, vaccine preparation and the chemotherapy regimens that were used. He also pointed out that the applicability of this approach in the era of rituximab therapy needs to be established in future trials.  

Other reasons for the success of this study may be related to the fact that the vaccine was offered only in first remission and after a minimum of six months of completion of the chemotherapy, thus allowing the immune system to recover and to be stimulated more effectively in response to the vaccine.

Tomorrow, I will discuss exciting new data that will be presented in the poster discussion session and the clinical science symposia, focusing on new promising agents for Hodgkin's and non-Hodgkin's lymphoma.


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