In advanced prostate cancer
TREAT FIRST-LINE WITH PROVENGE TO
EXTEND SURVIVAL

Pivotal trial results

The PROVENGE pivotal trial was designed to demonstrate an overall survival benefit

The pivotal trial was a Phase 3, randomized, double-blind, controlled study¹

• Primary endpoint—Overall survival
• Secondary endpoint—Time to objective disease progression

Trial Design¹

*Eligible patients were hormone refractory and had metastatic disease in the soft tissue and/or bone with evidence of progression; 18% had received prior chemotherapy (including docetaxel).
^†Control was nonactivated, autologous, peripheral blood mononuclear cells.
^‡Progression=radiographic evidence of disease progression.
^§Autologous, peripheral blood mononuclear cells that were cryopreserved at the time of control generation and subsequently activated.

64% of patients in the control group, following progression, crossed over to a nonrandomized open-label protocol to receive an investigational autologous immunotherapy made from cryopreserved cells¹

• Treatment in the open-label protocol was at the physician's discretion

PROVENGE extends median survival beyond 2 years

PROVENGE reduced the risk of death by 22.5% vs the control group (P=0.032)¹

Overall Survival Benefit of PROVENGE^1,2

Data originally published in The New England Journal of Medicine: Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.
Average time to subsequent therapy with docetaxel in the IMPACT trial was approximately 1 year.¹

PROVENGE provides a sustained survival benefit and a durable immune response

PROVENGE provided a survival benefit every year studied³

Overall Survival Benefit for PROVENGE³

^||(Percent PROVENGE-percent control)/percent control.

	Percentage of Patients Alive: ITT Population (95% CI)3
	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, 49.9) n=55	23.0% (15.5, 30.5) n=19	16.0% (8.5, 23.4) n=4

ITT=intent-to-treat.

PROVENGE provided a durable immune response³

• A sustained immune response to PROVENGE was seen out to 26 weeks in the pivotal study (the last time point measured)

PROVENGE provides a safety profile you and your patients can manage

Only 1.5% of patients treated with PROVENGE in the pivotal trial discontinued treatment due to adverse events³

92% of patients in the PROVENGE group in the pivotal trial received all 3 infusions³

The most common adverse events (≥15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache³

PROVENGE is not cleared by the liver or the kidneys and does not require dose adjustments or monitoring of liver/kidney functions

PROVENGE does not require concomitant steroids

Autologous use

• PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

Serious adverse events

• In controlled clinical trials, serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

Common adverse events

• The most common adverse events (incidence ≥15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

NEXT ARTICLE
NCCN Category 1 recommendation and patient selection

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.
Please see the Full Prescribing Information.

References

1. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.
2. PROVENGE [package insert]. Dendreon Corporation; June 2011.
3. Data on file. Dendreon Corporation.
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6. THIS NOTE COME FROM THE MANUFACTURER, NOT CRBCM, JUST FOR YOUR FYI