UPDATED: Agenus’ lead cancer vaccine flops, investigators read last rites over glioblastoma PhII Unfortunately, this trial failed. It may have failed because the vaccine was started too late - at the time of recurrence. It makes a lot more sense to try it for newly diagnosed healthier patients. Adding in a checkpoint inhibitor should also help. Lastly, with other vaccines, the early readings of the trial did not look good, but as time goes on, there was a small group of patients who do well for a much longer time than expected.
Tocagen Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Toca 511 & Toca FC in Recurrent High Grade Glioma This is very exciting news. I have always felt that it is almost criminal that most patients do not have access to treatments like this. They have shown that the treatment is safe, and early results show impressive results - at least a doubling of average survival with some patients still doing perfectly for a long time. This breakthrough therapy designation will speed up the process of approval. It opens the possibility that FDA approval could come based on the phase 2 trial which has completely enrollment and results should be available within a year, which means that FDA approval might be possible by the end of next year. Unfortunately not soon enough for anyone who has a brain tumor now. We still have to work on ways to make it available now to people who need it - possibly using compassionate use or the right to try laws.
