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Cancer immunotherapy-regulatory challenges for clinical studies
4th International Conference and Exhibition on Cell & Gene Therapy
August 10-12, 2015 London, UK
Bridget Heelan
Posters-Accepted Abstracts: J Stem Cell Res Ther
Abstract:
Some of the challenges relating to proof of concept, immune monitoring, patient section and clinical endpoints when
developing therapeutic cancer vaccines will be discussed. While the expected main mechanism of action of cancer
immunotherapy differs from standard chemotherapies, the need to show a clinically relevant benefit remains the ultimate goal
of treatment. When one of the mechanisms of action can be shown, this aids in biomarker identification, proof of concept
studies and dose finding. Some of the challenges in interpreting results from immune monitoring will be highlighted. The need
for adequate proof of concept studies prior to initiating phase 3 trials will be discussed.