The company said that in a substantial subset of patients at intermediate risk for disease recurrence, the phase III drug demonstrated a clinically significant improvement in recurrence-free survival of approximately 45%.
Antigenics added that Oncophage’s end-of-study results also revealed a new potential benefit associated with the drug. The company said that for intermediate-risk patients there was a trend towards improved overall survival, the study’s secondary endpoint.
The company confirmed that the late-stage results, which were collated from an additional 17 months of data collection, matched the positive overall survival trend demonstrated in earlier analyses.
The company is now setting up a global patient registry to continue collecting data on all patients from the trial for recurrence-free survival and overall survival. It is hoped that this initiative will provide additional data on the effectiveness of Oncophage.
The company also hopes to meet with the FDA to discuss these latest results and determine whether there is an opportunity to file a biologics license application.