PROVENGE: POWERFUL OVERALL SURVIVAL DATA
The PROCEED Registry
PROCEED is the largest real-world registry to evaluate the expected safety and survival profile of PROVENGE in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). PROCEED enrolled nearly 2000 men who received PROVENGE between 2011 and 2014 in an everyday treatment setting.1,2
PROCEED evaluated the expected safety and survival profile of PROVENGE. Among patients in the lowest baseline prostate-specific antigen (PSA) quartile (≤5.27 ng/mL), nearly half (44.1%) of the men in the registry received no additional cancer treatments for at least 1 year. Of these men, nearly 95% received sipuleucel-T (PROVENGE) as a first-line treatment.1 The National Comprehensive Cancer Network® (NCCN®) recommends sipuleucel-T (PROVENGE) as a first-line treatment option.3
In a post hoc analysis, median overall survival was greatest in men who started PROVENGE with a lower baseline PSA levela
For men whose PSA was ≤5.27 ng/mL: Median overall survival was nearly 4 years from the time of treatment1
In a subanalysis of patients with PSA-matched cohorts, African American men who received PROVENGE lived 20.9 months longer than PSA-matched Caucasian men with baseline PSA ≤29.48 ng/mL. In men with baseline PSA >29.48, median survival was 5.1 months longer for African American men.4,b
aPROCEED was a registry without a control group; all patients received PROVENGE. Patients may have received subsequent anti-cancer interventions per the local investigator’s standard of care.
bPROCEED was a registry to evaluate the safety of PROVENGE in a real-world setting whereby all patients received PROVENGE and there was no control group. The study was conducted to quantify the risk of cerebrovascular events and survival. Patients may have received subsequent anti-cancer interventions per the local investigator’s standard of care. This sub-group analysis of the PROCEED registry was exploratory and results need careful interpretation.
PROCEED findings were consistent with a post hoc analysis of the Phase 3 pivotal IMPACT trial5, which suggested that men who start PROVENGE when their PSA level is lower live longer.c
cThis post hoc analysis was not powered for statistical significance, and the population within the subgroups was not randomized. Therefore, the findings are limited by their exploratory nature.
IMPACT data suggest greater survival benefits for men who received PROVENGE earlier5,d
Data from the exploratory analysis suggest that men with a baseline PSA of ≤22.1 ng/mL when treated with PROVENGE lived more than 1 year longer than men who did not receive PROVENGE (hazard ratio [HR], 0.51; 95% confidence interval [CI], 0.31-0.85).5
dThis post hoc analysis was not powered for statistical significance, and the population within the subgroups was not randomized. Therefore, the findings are limited by their exploratory nature.
IMPACT: PROVENGE extended life for men with mCRPC6
IMPACT: In the pivotal, randomized clinical trial that supported FDA approval of PROVENGE, men who received the immunotherapy experienced a significant overall survival advantage. Nearly 38% more men who received PROVENGE were still alive 3 years posttreatment compared to control. 2
eThis information is data on file and represents an unpublished exploratory analysis.
| 1 year | 2 years | 3 years | 4 years | |
| PROVENGE | 81.1% (76.9, 85.3) n=274 |
52.1% (46.4, 57.7) n=129 |
31.7% (25.7, 37.8) n=49 |
20.5%(14.0, 26.9) n=14 |
| Control | 72.4% (65.6, 79.1) n=123 |
41.2% (33.5, 49.0) n=55 |
23.0% (15.5, 30.5) n=19 |
16.0% (8.5, 23.4) n=4 |
Tell me more about IMPACT
SIPULEUCEL-T (PROVENGE) IS RECOMMENDED BY NATIONALLY RECOGNIZED ORGANIZATIONS3,8,9
AUA recommends sipuleucel-T (PROVENGE)8
In mCRPC patients who are asymptomatic or minimally symptomatic, clinicians may offer sipuleucel-T. In sequencing agents, clinicians should consider prior treatment and consider recommending therapy with an alternative mechanism of action (Evidence Level: Grade B).
NCCN: A prominent category 1 recommendation3,i
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend considering sipuleucel-T (PROVENGE) as a first-line, preferred treatment option with a prominent category 1 designation in asymptomatic and minimally symptomatic mCRPC patients.
Sipuleucel-T (PROVENGE) is also a category 2A recommendationj
NCCN Guidelines® also recommend considering sipuleucel-T (PROVENGE) as a preferred second-line treatment option after abiraterone or enzalutamide.Treatment with sipuleucel-T (PROVENGE) does not preclude the use of subsequent therapies.
iBased upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
jBased upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
SITC recommends sipuleucel-T (PROVENGE)9
The current evidence-based recommendation for the use of sipuleucel-T (PROVENGE) in the management of mCRPC in asymptomatic or minimally symptomatic patients is supported by Level A evidence from randomized trials and meta-analyses. Sipuleucel-T (PROVENGE), may achieve greater benefit among mCPRC patients treated earlier in the course of the disease.