PROVENGE: POWERFUL OVERALL SURVIVAL DATA
IMPACT: PROVENGE extended life for men with mCRPC1,2
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.
aHazard ratio and P value based on the Cox proportional hazards model adjusted for PSA (ln) and LDH (ln) and stratified by bisphosphonate use, number of bone metastases, and primary Gleason score.
CI, confidence interval; LDH, lactate dehydrogenase; ln, logarithm; PSA, prostate-specific antigen; mCRPC, metastatic castration-resistant prostate cancer.
| 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) | 0.775a (0.614, 0.979) |
|
| P value | 0.032a | |
bThis information is data on file and represents an unpublished exploratory analysis.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 |
IMPACT data suggest longer overall survival benefits for men who start PROVENGE with a lower PSA level4,c
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
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.
Tell me about IMPACT
The Medicare beneficiary study of PROVENGE
A retrospective observational analysis of the Medicare fee-for-service 100% dataset was examined to evaluate the effect of PROVENGE and the androgen-receptor signaling pathway inhibitors (ASPIs) abiraterone acetate and enzalutamide on overall survival (OS) in men treated for advanced prostate cancer. The study identified 6044 men with a prostate cancer diagnosis who received either PROVENGE or ASPIs in 2014. These men were then observed during the 3-year period from 2014-2017 or until death.5
This study measured outcomes for 2 analysis cohorts.
Any-line cohort:
Examined any-line treatment with PROVENGE and any-line treatment with ASPIs but not PROVENGE.f
First-line cohort:
Examined first-line treatment with PROVENGE and first-line treatment with an ASPI.
At 36 months
Median OS in men receiving PROVENGE in any line of treatment was 14.5 months longer than for those receiving ASPIs in any line of treatment (but not PROVENGE)
fMen in the any-line cohort could have received any other agent during the observation period except for those in the ASPI group who by definition did not receive PROVENGE.
At 36 months
Median OS in men receiving PROVENGE in first line of treatment was nearly 14 months longer than for those receiving an ASPI in first line of treatment
The study analysis suggests that the use of PROVENGE at any time was associated with improved OS compared with ASPI use alone.
Claims analyses like these are limited in their ability to reliably predict treatment effects, and individual results may vary. This claims dataset does not include safety or certain clinical assessments; the analysis was exploratory and the results need careful interpretation.
The PROCEED Registry
PROCEED is the largest real-world registry to evaluate the safety and survival profile of PROVENGE in men with asymptomatic or minimally symptomatic mCRPC. The registry, which was conducted between 2011 and 2017, enrolled nearly 2000 men who received PROVENGE in an everyday treatment setting.6
PROCEED evaluated the 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.6
In a post hoc analysis of the PROCEED registry, median overall survival was greater in men who started PROVENGE with a lower baseline PSA level6,g
For men whose PSA was ≤5.27 ng/mL: Median overall survival was nearly 4 years from the time of treatment selection6
In a subanalysis of patients with PSA-matched cohorts,
African American men lived longer than Caucasian men7,g,h
gThe PROCEED registry evaluated the 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.
hThis subgroup analysis of the PROCEED registry was exploratory and results need careful interpretation.
SIPULEUCEL-T (PROVENGE) IS RECOMMENDED BY NATIONALLY RECOGNIZED ORGANIZATIONS8,9
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).
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.