FULL PRESCRIBING INFORMATION

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.

Summary of Overall Survival
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
Nearly 38% more men who received PROVENGE were still alive 3 years posttreatment compared to control.7

fThis information is data on file and represents an unpublished exploratory analysis.

IMPACT: Percentage of patients alive—ITT population (95% CI)7
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
ITT, intent to treat.

Tell me about IMPACT

References:
1.
Higano CS, Armstrong AJ, Sartor AO, et al. Real-world outcomes of sipuleucel-T treatment in PROCEED, a prospective registry of men with metastatic castration-resistant prostate cancer. Cancer. 2019;125(23):4172-4180. doi:10.1002/cncr.32445
2.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed May 21, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
3.
Sartor O, Armstrong AJ, Ahaghotu C, et al. Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry. Prostate Cancer Prostatic Dis. Published online February 28, 2020. doi:10.1038/s41391-020-0213-7
4.
Schellhammer PF, Chodak G, Whitmore JB, Sims R, Frohlich MW, Kantoff PW. Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial. Urology. 2013;81(6):1297-1302. doi:10.1016/j.urology.2013.01.061
5.
Kantoff PW, Higano CS, Shore ND, et al; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363(5):411-422. doi:10.1056/NEJMoa1001294
6.
PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.
7.
Data on file. Dendreon Pharmaceuticals LLC.
8.
Cookson MS, Roth BJ, Dahm P, et al. Castration-resistant prostate cancer: AUA guideline. J Urol. 2013;190(2):429-438. doi:10.1016/j.juro.2013.05.005
9.
McNeel DG, Bander NH, Beer TM, et al. The Society for Immunotherapy of Cancer consensus statement on immmunotherapy for the treatment of prostate carcinoma. J Immunother Cancer. 2016;4:92. doi:10.1186/s40425-016-0198-x
INDICATION

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

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