Personalized Vaccine with Patient’s Own Tumor Cells Prolongs Survival in Follicular Lymphoma Compared to Control Vaccine

A customized vaccine using a patient’s own tumor cells called BiovaxID, prolonged disease-free survival in patients with follicular lymphoma who maintained complete remission after chemotherapy for one year and were then treated with the vaccine. The 8-year long randomized, double-blind, phase II study found that patients who received the patient-specific vaccine had a median of 14 months longer disease-free survival compared with those who received a control vaccine (KLH vaccine).

“With this vaccine, we’ve moved into an era where we can safely use a patient’s immune system to effectively fight follicular lymphoma and enhance response to conventional chemotherapy,” said Stephen J. Schuster, MD, Associate Professor at the University of Pennsylvania in Philadelphia. Dr. Schuster presented study results at the Plenary Session during ASCO 2009.

The vaccine was made from tumor-derived idiotype protein unique to each lymphoma tumor that was isolated from individual patient samples and linked to the hemocyanin protein from the keyhole limpet (KLH). It is given simultaneously with GM-CSF growth factor support. The control vaccine included KLH plus GM-CSF.

BiovaxID is designed to recruit the patient’s immune system to find and destroy tumor B cells selectively, and this approach may prove useful for other B-cell lymphomas, Dr. Schuster told listeners at a press conference.

The study enrolled 234 chemotherapy-naïve patients with stage III/IV or bulky stage II follicular lymphoma. All patients were treated with PACE chemotherapy (cyclophosphamide, doxorubicin, etoposide, and prednisone), a regimen not commonly used to treat follicular lymphoma these days. Patients who achieved complete remission for at least 6 months (n. 117) were randomized to either the BiovaxID or a conventional KLH control vaccine.

One third of patients progressed between the time of CR and the time that the vaccine was prepared and did not get the vaccine. Of the 177 patients who received at least one dose of vaccine, 60 of them relapsed.

In a modified intent-to-treat analysis that included only the 117 patients vaccinated in remission, disease-free survival was 44.2 months with BiovaxID versus 30.6 months with the control vaccine, representing a 38% risk reduction (P=.045 log rank test).

The vaccine was well tolerated, with no difference between treatment arms in the frequency and nature of grade 3 and 4 adverse events. Local injection site reactions were similar in both groups.

“Complete remission could be a prerequisite for achieving a benefit from the BiovaxID,” said Dr. Schuster

The study was initiated using chemotherapy that was standard of care 8 years ago. Rituximab-containing chemotherapy is the current standard of care. “We will study use of the vaccine after achieving complete remission on rituximab combination chemotherapy regimens,” Dr. Schuster stated.

The study was sponsored by Biovest International.