Table 2.
Completed phase III trials: immunotherapy and therapeutic cancer vaccines in prostate cancer.
| Agent | Primary endpoint | Comments |
|---|---|---|
| Sipuleucel-T (two identically designed, randomized, double-blind, placebo-controlled trials) D9901, D9902A | Time to disease progression | Improved OS, no improvement in TTPIntegrated analysis (n = 225)Treatment group with 33% reduction in risk of death (HR 1.50; 95% CI 1.10–2.05; p = 0.011) |
| Sipuleucel-T (IMPACT) | OS | Improved OS compared with placebo (n = 512): 25.8 versus 21.7 months; HR 0.78; 95% CI, 0.61–0.98Led to FDA approval in 2010 |
| GVAX (VITAL-1)GVAX versus docetaxel-prednisone | OS | GVAX compared with docetaxel (HR 1.01) – trial stopped early after futility analysis |
| GVAX (VITAL-2)Docetaxel versus docetaxel-GVAX | OS | Apparent worse outcome with vaccine compared to docetaxel – trial halted |
| IpilimumabDouble-blind trial ipilimumab versus placebo | OS | No improvement in OS (HR 0.85; 95% CI 0.72–1.00; p = 0.053); however, improved OS in subgroup with less advanced diseaseApparent improvement in PFS |
CI, confidence interval; FDA, Food and Drug Administration; HR, hazard ratio; OS, overall survival; PFS, progression-free survival; TTP, time to progression.