BiovaxID Vaccine Shows High Overall Survival in Mantle Cell Lymphoma


Biovest has announced that the National Cancer Institute (NCI) has presented outcomes at this past weekend's American Society of Clinical Oncology annual meeting from a Phase II BiovaxID lymphoma vaccine clinical trial.

The results of the clinical trial showed thatvaccination with BiovaxID following rituximab combination chemotherapy induced nearly universalT-cellimmune responses that strongly correlated with overall survival (OS)and time-to-next treatment benefits in patients with the aggressiveB-cellnon-Hodgkin's lymphoma, mantle cell lymphoma (MCL).

BiovaxID improved survival time

"We found that among MCL patients treated with a hybridoma-based idiotype vaccine, patients who had T-cells that produced GM-CSF when exposed to tumor antigen had a significantly longer survival and delayed time to next treatment compared to patients who did not have GM-CSF producing T-cells," Said principal investigator Wyndham H. Wilson, M.D., Ph.D., Chief of the Lymphoma Therapeutics Section at NCI and the of the MCL study, "Interestingly, studies have shown that GM-CSF producing T-cells are important for promoting autoimmunity, which is what we hope an antitumor vaccine will do. In the latter case, the autoimmunity is against a tumor antigen and not a normal cell."

The study (involving 24 participants), with 122 months of median potential follow-up, showed a median overall survival of 104 months, a time that exceeded reported historic OS rates for 'low-risk' MIPI patients and substantially exceeding reported historic overall survival rates for 'high-risk' and 'intermediate-risk' MIPI patients.

In sum, the study shows a statistically-significant association between OS and specific vaccine-induced anti-tumor GM-CSF cytokine (T-cell) responses.

Sattva S. Neelapu, M.D., Associate Professor at the Department of Lymphoma/Myeloma, Division of Cancer Medicine, MD Anderson Cancer Center, co-investigator of this Phase II study and an investigator on another trial, noted that "These results complement the body of data supporting the safety and efficacy of BiovaxID."

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