BiovaxID Phase III Clinical Trial Summary
At the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session, Biovest presented the results from its 8-year, randomized, multi-center, double-blind, controlled Phase III trial showing that BiovaxID significantly prolonged disease-free survival in follicular lymphoma patients.
The trial measured disease-free survival for two prospectively-defined patient populations: 1) all randomized patients and; 2) all randomized patients that were vaccinated with either BiovaxID or the control vaccine. The statistically significant results (p=0.045) achieved by comparing patients treated with BiovaxID versus patients treated with control showed that patients who received BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6 months for those who received a control vaccine – an increase of over a year on average. In the study, with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine.
BiovaxID is the first ever cancer vaccine targeting lymphoma to demonstrate such a disease-free survival benefit in a Phase III trial.
Disease-free survival (DFS) according to study group for the randomized patients who received blinded vaccinations (N = 117). Kaplan-Meier actuarial curves for DFS for the randomized patients who received at least one dose of the Id-KLH+GM-CSF (N = 76) or KLH+GM-CSF (N = 41) are shown. The number of events, median, and 95% confidence intervals for each group are also presented.