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BiovaxID, an individualized tumor-specific protein vaccine, prolongs disease-free survival in patients with advanced follicular lymphoma who experience complete remission for six months or longer following first-line treatment with the chemotherapy regimen PACE, according to the results of a study presented at the 2009 annual meeting of the American Society of Clinical Oncology in Orlando, Florida.[[1]]( "_ednref1")

Non-Hodgkin’s lymphoma (NHL) is a form of cancer that begins in the cells of the lymph system. It is characterized by excessive accumulation of cancerous lymphocytes, which can crowd the lymph system and suppress the formation and function of other immune and blood cells. Indolent, or low-grade, NHL refers to lymphoma that grows and spreads slowly and has few symptoms. Follicular lymphoma (FL) is a type of indolent NHL that affects the B-cells of the lymph system.

Treatment for indolent NHL often includes initial therapy, referred to as induction therapy, as well as continued therapy, referred to as maintenance therapy. Maintenance therapy is used for extended periods to provide continued suppression of the cancer.

BiovaxID is an individualized vaccine that is made by removing a patient’s cancer cells and mixing them with immune cells and agents that stimulate the immune system. Once injected, the vaccine stimulates immune cells to recognize and fight cancer cells that may be in the body. It takes approximately 6-12 months to produce the vaccine.

Researchers conducted a randomized, double-blind, placebo-controlled Phase III multicenter study to evaluate disease-free survival in patients with advanced FL who received the BiovaxID vaccine after a complete remission of six months or more. The study originally enrolled 234 patients, 177 of whom were randomized and 117 of whom maintained a complete response long enough to receive the vaccine.

At the time of this study, the standard induction therapy for FL was a regimen called PACE, which consists of prednisone, Adriamycin® (doxorubicin), Cytoxan® (cyclophosphamide), and Toposar® (etoposide). (Since then, standard therapy has evolved to include the targeted agent Rituxan® [rituximab].) All patients received PACE and after a complete remission of six months or more, 76 patients received the BiovaxID vaccine and 41 received a control vaccine (placebo).

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After a median follow-up of nearly five years, disease-free survival among patients who received the BiovaxID vaccine was 44.2 months compared with 30.6 months among patients who received the control. The overall survival rate for the vaccine group was 95.4% compared with 91.2% for the placebo group. The vaccine was well-tolerated.

The researchers concluded that the BiovaxID vaccine is a promising new agent that may be beneficial for patients who have maintained a complete remission for six months or longer. The advent of Rituxan has improved the treatment for FL, leaving the role of vaccines still under debate.


[[1]]( "_edn1") Schuster SJ, Neelapu SS, Gause, BL, et al. Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results. Presented at the 2009 annual meeting of the American Society of Clinical Oncology, May 29-June 2, 2009, Orlando, FL. Abstract 2.

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