You always make my day!Shot of a woman hugging her husband

Immunotherapy for Advanced Prostate Cancer

Immunotherapy for Advanced Prostate Cancer

Immune system defends the body against infections and diseases

What is the immune system?

The immune system is made of a variety of cells working together as the body’s defense against foreign invaders, such as infection or cancer cells. One of the natural abilities of the immune system is to detect abnormal cells, including cancer cells, and destroy or prevent them from spreading. In some cases, cancer may overwhelm or hide from the immune system and spread to other parts of the body.

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your immune system fight cancer. There are several different types of immunotherapy (for example, cellular therapies, CAR-T therapies, and checkpoint inhibitors). 

rendering of fighting cancer in the body
Couch Bg 2174586893
hugging couple

Why PROVENGE immunotherapy?

PROVENGE is a personalized immunotherapy that activates your body’s immune system to fight advanced prostate cancer. Studies have shown that certain men who receive PROVENGE live longer.

PROVENGE is recommended by nationally recognized medical organizations.

PROVENGE Treatment Overview

PROVENGE has been proven to extend life for certain men with mCRPC.

Studies suggest men who receive PROVENGE when their PSA level is lower may live longer.a

Mechanism of Action

  • Antigen-presenting cells (APCs) are collected from the patient’s blood.
  • These APCs play a crucial role in helping your immune system to fight advanced prostate cancer.
  • In a laboratory, the collected APCs are exposed to a protein called prostatic acid phosphatase (PAP), which is found on prostate cancer cells.
  • This exposure activates APCs to recognize and remember the PAP antigen, which is crucial for targeting prostate cancer cells.
  • The activated population of APCs is prepared for infusion back into your body.
  • Once inside your body, PROVENGE interacts with your immune system, particularly with types of white blood cells called T cells and B cells.
  • PROVENGE stimulates your T cells to recognize and attack prostate cancer cells.
Mechanism of Action

PROVENGE Immunotherapy Results

PROVENGE has been proven to help certain men live longer. 

Perhaps PROVENGE can help you.

Exploratory analysis of IMPACT

Combined Shape

IMPACT was a randomized, placebo-controlled trial that studied men diagnosed with mCRPC. This study included 512 men, comparing men who received PROVENGE with men who did not receive PROVENGE.

Time Flies

In IMPACT, PROVENGE extended life for certain men with mCRPC. Further exploratory analysis suggests that men with a lower PSA level who receive PROVENGE may live longer.

Median overall survival 13 months longer

In all 4 groups of the exploratory analysis, studies suggest men who received PROVENGE saw improved median overall survival when compared to men who did not receive PROVENGE (control).

Analysis was exploratory and individual results may vary.

Chart@4000x
a. PSA less than or equal to 22.1 ng/mL.

PROCEED is the largest real-world study of immunotherapy involving men with mCRPC who were treated with sipuleucel-T.

007 Candidate Search

PROCEED was an observational study that evaluated the safety and survival of nearly 2,000 men who received PROVENGE. The patients were followed between 2011 and 2017.

Combined Shape

Men who started PROVENGE when their PSA level was lower had a median overall survival of nearly 4 years (47.7 months).

669bc9132ae96-Doctor

These men may have received other therapies, in addition to PROVENGE, as prescribed by their doctor.

669bc9132b78b-smashicons_health_and_safety_first-aid-kit-icon-57-outline

The most common side effects reported during this registry were consistent with previous studies: generally mild to moderate and well tolerated. Please see Important Safety Information for additional details.

In a post hoc analysis, men who started PROVENGE
with a lower PSA level lived longerc

Median overall survival 4 years

The 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.

Bar graph
Container
Pie chart

44% of men in this registry did not receive any additional cancer treatments for at least 1 year. Nearly 95% of these men were treated with PROVENGE as a first-line treatment option.

Senior black man at graduation with his daughter
In a subanalysis of patients with PSA-matched cohorts, African American men lived longer than Caucasian men.

This subgroup analysis of the PROCEED registry was exploratory and results need careful interpretation.

669bc9132c34f-User

Baseline PSA
≤29.48 ng/mL

Combined Shape

Median Overall
Survival

Combined Shape

Longer Survival

In men with baseline PSA ≤29.48 ng/mL who received PROVENGE,

median overall survival for African American men (n=107) was 54.3 months, vs 33.4 months for PSA-matched Caucasion men (n=222) an additional 20.9 months

In men with baseline PSA >29.48 ng/mL who received PROVENGE,

median overall survival was 5.1 months longer for African American men (n=112) than for PSA-matched Caucasian men (n=216)

Biker Background
Man on his bike

PROVENGE and PSA level

PROVENGE works differently from other cancer treatments, such as chemotherapy or hormone therapy. Unlike these treatments, PROVENGE may not lower your PSA level. The goal of treatment with PROVENGE is not to lower PSA level, it is to extend life and activate your immune system to fight your prostate cancer.

Doc Office 1366650120
Doctor speaking with her patient

When is the right time for PROVENGE Immunotherapy?

PROVENGE may be considered before or after receiving other treatments for advanced prostate cancer. PROVENGE has no contraindications, and does not preclude other treatments for prostate cancer.

Common side effects of Immunotherapy

The most common side effects of PROVENGE are generally mild to moderate and are well tolerated.

Most infusion-related side effects are resolved within 1 or 2 days.

There are potential risks associated with PROVENGE:

  • In controlled clinical trials, 71.2% of men treated with PROVENGE developed an acute infusion reaction

The most common adverse events ≥20% were chills, fever, and fatigue. In 95.1% of men reporting acute infusion reactions, the reactions were mild or moderate. Acute infusion reactions were generally resolved within 2 days (71.9% and 89%, respectively)

  • 1.5% of men discontinued their treatment with PROVENGE due to adverse events

The most common side effects of treatment with PROVENGE include:

Common side effects

PROVENGE infusion can cause serious reactions. Tell your doctor right away if:

  • You have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after receiving PROVENGE. Any of these may be signs of heart or lung problems
  • You develop numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking. Any of these may be signs of a stroke
  • You develop symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain that worsens on deep breathing
  • You get a fever over 100°F, or redness or pain at the infusion or collection sites. Any of these may be signs of infection

These are not all the possible side effects of treatment with PROVENGE. For more information, talk with your doctor. Please see Important Safety Information

INDICATION

PROVENGE® (sipuleucel-T) is a prescription medicine used to treat certain men with advanced prostate cancer. PROVENGE is an established cellular immunotherapy and is customized to each individual by using his own immune cells.

IMPORTANT SAFETY INFORMATION

Before receiving PROVENGE®, tell your doctor about any medical conditions, including heart or lung problems, or if you have had a stroke.

Tell your doctor about any medicines you take, including prescription and nonprescription drugs, vitamins, or dietary supplements.

The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment.

PROVENGE is made from your own immune cells, which are collected during a process called leukapheresis. The cells are processed, returned, and then infused back into the patient through an IV (intravenous) infusion about 3 days later. This process is completed in 3 cycles, about 2 weeks apart. Each infusion takes approximately 1 hour and requires 30 minutes of post-infusion monitoring.

PROVENGE infusion can cause serious reactions. Tell your doctor right away if you:

  • Have signs of a heart attack or lung problems, such as trouble breathing, chest pains, racing or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting
  • Have signs of a stroke, such as numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking
  • Develop symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, shortness of breath, chest pain that worsens or deep breathing
  • Have signs of infection such as a fever over 100°F, redness or pain at the infusion or collection sites

Tell your doctor about any side effect(s) that concerns you or does not go away. For more information, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Full Prescribing Information.

To report an adverse event, please email our Pharmacovigilance department at drugsafety@dendreon.com, or fax adverse event details to 833-464-0123. Please provide details pertaining to the adverse event and provide contact information so that our Pharmacovigilance team may contact you with any questions.

To report a product complaint, email our Quality department at CQAcomplaints@dendreon.com. Please provide details pertaining to the quality issue and provide contact information so that our Quality team may contact you with any questions.

PRV.0018.USA.23