Phase 2 Study Update of BiovaxID for Mantle Cell Lymphoma

Biovest International announced the results from a Phase 2 BiovaxID lymphoma vaccine clinical trial. The results demonstrated that vaccination following Rituxan (rituximab; Genentech) combination chemotherapy induced nearly universal T-cell immune responses, the elevation of which strongly correlated with overall survival and time-to-next treatment benefits in patients with mantle cell lymphoma (MCL).

The study (n=24), with 122 months of median potential follow-up (range: 111–132 months), demonstrates a median overall survival of 104 months, exceeding reported historic overall survival rates for ‘low-risk' MIPI patients and substantially exceeding reported historic overall survival rates for ‘high-risk' and ‘intermediate-risk' MIPI patients. Furthermore, the study demonstrates a highly statistically-significant association between overall survival and specific vaccine-induced anti-tumor GM-CSF cytokine (T-cell) responses.

Patients with a high degree of this T-cell response to vaccination experienced an estimated survival of approximately 75% at 10 years, compared to a survival of approximately 25% in the group of patients with a low degree of T-cell GM-CSF responses. Overall, patients with the T-cell response experienced an approximately three-fold improvement in their probability of survival compared with those did not achieve this response to vaccine.

There was also a highly statistically significant association between the BiovaxID-induced T-cell response and time-to-next-treatment benefit with a nearly a 10-fold improvement for those patients that developed this specific BiovaxID-induced T-cell response vs. those who did not (51.9 months vs. 5.5 months from the time of first progression).  

BiovaxID is a patient-specific cancer vaccine.

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