Heat Biologics' HS-410 bladder cancer trial did not meet primary endpoint
Heat Biologics presented topline data from its 94-patient Phase II trial evaluating HS-410 in combination with standard of care, Bacillus Calmette-Guerin, or as a monotherapy, for the treatment of non-muscle invasive bladder cancer, at the Society of Urologic Oncology Annual Meeting in San Antonio, TX. Researchers reported that there were encouraging signs of anti-tumor activity as HS-410 generated a robust antigen-specific immune response to multiple tumor-associated peptides in treated patients, while there were no immune responses of this type in the placebo. However, these responses did not translate into clinical outcomes, and there was no statistically significant difference in the primary endpoint - proportion of recurrence-free survival at one year - between the vaccine and placebo arms of the trial. Heat will continue to monitor all patients enrolled in the study for an additional 12 months. At that time, Heat will make a final determination whether to progress its bladder cancer program into a Phase 3 trial.