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). The registry, which was conducted between 2011 and 2017, enrolled nearly 2000 men who received PROVENGE in an everyday treatment setting.1
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.2
In a post hoc analysis, median overall survival was greatest in men who started PROVENGE with a lower baseline PSA level1,a
For men whose PSA was ≤5.27 ng/mL: Median overall survival was nearly 4 years from the time of treatment selection1
In a subanalysis of patients with PSA-matched cohorts,
African American men lived longer than Caucasian men3,a,b
aThe PROCEED registry evaluated the expected safety and survival profile of PROVENGE received by patients in a real-world setting in which 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.
bThis subgroup 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 trial4, which suggests 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 earlier4,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).4
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 mCRPC5,6
In IMPACT, the double-blind, placebo-controlled trial that supported FDA approval of PROVENGE, men with mCRPC (N=512) were randomly assigned in a 2:1 ratio to receive either sipuleucel-T (n=341) or placebo (n=171). The primary endpoint was overall survival. Men who received the immunotherapy experienced a significant overall survival advantage.
eHazard ratio and p-value based on the Cox Model adjusted for PSA (ln) and LDH (ln) and stratified by bisphosphonate use, number of bone metastases, and primary Gleason grade.
CI, confidence interval; ln, logarithm; LDH, lactate dehydrogenase.
| PROVENGE (N=341) |
Control (N=171) |
|
| Overall Survival Median, months (95% CI) | 25.8 (22.8, 27.7) |
21.7 (17.7, 23.8) |
| Hazard Ratio (95% CI) | 0.755e (0.614, 0.979) |
|
| P-value | 0.032e | |
fThis 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 about IMPACT
SIPULEUCEL-T (PROVENGE) IS RECOMMENDED BY NATIONALLY RECOGNIZED ORGANIZATIONS2,8,9
AUA recommends sipuleucel-T (PROVENGE)8
In men with mCRPC 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 recommendation2,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 in men with mCRPC.
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.