Table 1.

Key trial results of Sipuleucel-T in prostate cancer.

Ref.	Trial and population	Patients (n)	Summary of key findings
Kantoff et al. [1]	Phase 3 trial in metastatic castration resistant prostate cancer	512	Demonstrated an improvement in overall survival of 25.8 months in the sipuleucel-T arm of the study compared to 21.7 months in the placebo arm (hazard ratio, 0.78; 95% confidence interval, 0.61 to 0.98; p = 0.03)
Schellhammer et al. [13]	Phase 3 trial in metastatic castration resistant prostate cancer	512	A retrospective analysis suggested that patients with a PSA less than or equal to 22.1 ng/mL had a 62.6% three-year estimated survival after treatment with sipuleucel-T compared to 41.6% in the placebo group. These data suggest that patients with lower tumor volume may benefit most from sipuleucel-T
Fong et al. [9]	A phase 2 study using sipuleucel-T in the neoadjuvant setting before radical prostatectomy	42	The study found a greater than three-fold increase in infiltrating T cells at the benign tissue-tumor interface within the prostate (p < 0.001) after treatment with sipuleucel-T compared to pre-treatment biopsies. This study suggested that sipuleucel-T can mobilize T cells to the tumor microenvironment

PSA, prostate specific antigen.