Immunotherapy. 2011 Jan;3(1):27-31. doi: 10.2217/imt.10.77.
Immunotherapy
Ravi A Madan, James L Gulley
PMID: 21174555 PMCID: PMC3474245 DOI: 10.2217/imt.10.77
For many years, preclinical and clinical studies have attempted to harness the power of the immune system and focus it on malignant cells in an attempt to improve clinical outcomes for patients with cancer. This paper describes the landmark Phase III trial that led to the first US FDA approval of a therapeutic cancer vaccine. In a randomized trial of 512 patients, those treated with sipuleucel-T survived for 25.8 months compared with those treated with placebo, who survived 21.7 months (HR: 0.78; p = 0.03). There was, however, no change in time to progression, which may relate to the underlying mechanism of this new class of therapeutics.