An 8-year randomized, controlled phase III clinical study has shown that a patient-specific therapeutic vaccine, BiovaxID, significantly prolongs disease-free survival in follicular non-Hodgkin’s lymphoma. The study, featured in ASCO’s plenary session, found that patients who received the vaccine experienced a median disease-free survival of approximately 44 months compared to approximately 30 months for those who received a control vaccine—an increase of 47% (abstract P2).
BiovaxID is individually manufactured from a tissue biopsy obtained from a patient’s own tumor. The vaccine targets a unique protein (idiotype) expressed by cancerous B cells in follicular lymphoma and spares normal, healthy B cells that do not express the tumor idiotype. The final vaccine is administered as a subcutaneous injection along with granulocyte-macrophage colony-stimulating factor (GM-CSF, Leukine) and keyhole limpet hemocyanin (KLH), which together enhance the potency of the immune response induced by BiovaxID.
“With this vaccine, we’ve now moved into an era where we can safely use a patient’s immune system to effectively fight follicular lymphoma and enhance the response to conventional chemotherapy,” said Stephen J. Schuster, MD, associate professor at the University of Pennsylvania School of Medicine and the study’s lead author.
The study achieved its primary endpoint of prolonging disease-free survival in patients vaccinated with BiovaxID after achieving a complete response to chemotherapy. In the study, 177 patients with follicular lymphoma who had achieved a complete response to PACE (prednisone, doxorubicin(Drug information on doxorubicin), cyclophosphamide(Drug information on cyclophosphamide), and etoposide(Drug information on etoposide)) chemotherapy were randomized to the BiovaxID vaccine arm (vaccine plus KLH/GMCSF) or to the control arm (KLH/GM-CSF alone). Investigators analyzed the cohort of 117 patients who maintained a complete response to chemotherapy for at least 6 months and received active (76 patients) or control (41 patients) vaccine. After a median follow-up of 4.71 years, the median disease-free survival in the BiovaxID arm was 44.2 months compared with 30.6 months in the control arm.