Here are some snippets of the article that I feel could be possibly considered negative, in that more research must be done, certain things are still unknown etc. At the end of the article in makes it appear that the current Phase III trial is just a start and other trials might be needed .... does this mean they do not believe the current trial will be successful and perhaps combination trials will need to follow in order to get FDA approval (perhaps because FDA will want evidence of overall survival improvement instead of "just PFS)?
Although the initial results appear promising, questions and challenges remain. The choice of best tissue to derive the TAA is a matter of debate.
Enhancing immune responses to overcome tumor-induced immunosuppression, in an attempt to improve the outcome of DC vaccination, is a strategy used in a number of studies.
Further work is needed to clarify this area.
Another need (not addressed so far) = identification of a physiological biomarker of the triggered immune response against the tumor.
No strong or uniform correlation yet. Lack of prognostic value.
Several areas still being actively researched in order to identify promising candidate biomarkers of
response to treatment.
Optimal timing of DC vaccinations?
Interaction between DC vaccinations & radiotherapy remains controversial.
... a clear need for optimization of DC vaccine protocols so that synergy between the treatment modalities can be achieved.
The ongoing (recruiting initially in the USA and now in Europe) Phase III trial is a first attempt to meet this challenge and is likely to be followed up by others to finally define the place of this therapy in the management of patients with GBM.
