About the Clinical Study in mCSPCi

ERLEADA® + ADT was compared with placeboi+ ADT in a clinical study of 1,052 men with mCSPC

mCSPC is prostate cancer that HAS SPREAD to other parts of the body and STILL responds to medical or surgical treatment that lowers testosterone

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In this study, men either received ERLEADA® 240 mg once daily or placebo. All men in the study received ADT

525 men received ERLEADA® + ADT, 527 men received Placebo + ADT

ADT: Androgen deprivation therapy (ADT) includes medical or surgical treatment that lowers testosterone.

mCSPC: Metastatic castration-sensitive prostate cancer (mCSPC) is prostate cancer that HAS SPREAD to other parts of the body and STILL responds to medical or surgical treatment that lowers testosterone.

Placebo: Pronounced “pluh-see-bow”: a pill that looks like “real” medicine but contains nothing to affect health.

ERLEADA® was shown to help men live longer

35% Reduction in the risk of death

In a clinical study, ERLEADA® + ADT reduced the risk of death by 35% vs placebo + ADT*

Median (middle) follow-up time was 44.0 months. In an earlier analysis from the study, the reduction in the risk of death was 33%

Here’s another way to look at the results:

At 4 years, approximately 65% of men taking ERLEADA® + ADT were alive vs 52% of men taking placebo + ADT*

*Median (middle) data has not been reached for ERLEADA®.

ERLEADA® reduced the risk of prostate cancer getting worse

52% Reduction in the risk of progression

In a clinical study, ERLEADA® + ADT reduced the risk of prostate cancer getting worse by 52% vs placebo + ADT

Here’s another way to look at the results:

At 2 years, approximately 68% of men taking ERLEADA® + ADT lived without their disease getting worse vs 48% of men taking placebo + ADT

Median (middle) data has not been reached for ERLEADA®.

 

ERLEADA® helped men achieve a zero PSA level

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ERLEADA® + ADT helped more than twice as many men achieve a zero PSA (prostate-specific antigen) level vs placebo + ADT (68% vs 32%)§

Zero PSA level = <0.2 ng/mL.

§The relationship between ERLEADA® and PSA is not fully known.

ERLEADA® may delay the need for chemotherapyi

61% of Reduction in the risk of beginning chemotherapy

ERLEADA® + ADT reduced the risk of beginning chemotherapy by 61% vs placebo + ADT

Median (middle) data has not been reached.

ADT: Androgen deprivation therapy (ADT) includes medical or surgical treatment that lowers testosterone.

Chemotherapy: Type of drug(s) that kill cancer cells.

Median: The middle number in a set of numbers. For 50% of people, this value was larger, and for 50% of people, it was smaller.

mCSPC: Metastatic castration-sensitive prostate cancer (mCSPC) is prostate cancer that HAS SPREAD to other parts of the body and STILL responds to medical or surgical treatment that lowers testosterone.

Placebo: Pronounced “pluh-see-bow”: a pill that looks like “real” medicine but contains nothing to affect health.

Progression: Disease spreading further as measured by imaging studies or dying.

Prostate-specific antigen (PSA): A protein made by the prostate and found in the blood. Those with prostate cancer may have PSA blood levels that are higher than normal.

Time to chemotherapy: Length of time from when patients began study to starting chemotherapy.

About the Clinical Study in nmCRPCi

ERLEADA® + ADT was compared with placeboi + ADT in a clinical study of 1,207 men with nmCRPC

nmCRPC is prostate cancer that HAS NOT SPREAD to other parts of the body and NO LONGER responds to a medical or surgical treatment that lowers testosterone

pill icon

In this study, men either received ERLEADA® 240 mg once daily or placebo. All men in the study received ADT

Graphic of clinical study patients, 806 men received ERLEADA® + ADT, 401 men received Placebo + ADT

ADT: Androgen deprivation therapy (ADT) includes medical or surgical treatment that lowers testosterone.

nmCRPC: Non-metastatic castration-resistant prostate cancer (nmCRPC) is prostate cancer that HAS NOT SPREAD to other parts of the body and NO LONGER responds to medical or surgical treatment that lowers testosterone.

Placebo: Pronounced “pluh-see-bow”: a pill that looks like “real” medicine but contains nothing to affect health.

ERLEADA® helped men with nmCRPC live longer without the spread of prostate cancer

40.5 months with ERLEADA® + ADT vs. 16.2 months with Placebo + ADT

In a clinical study, ERLEADA® + ADT delayed the spread of cancer to other parts of the body or death by a mediani of 24.3 months compared with placebo + ADT.

The clinical study for men with nmCRPC also evaluated:

Overall Survival: Living Longer

Men taking ERLEADA® + ADT lived 14 months longer than men taking placebo + ADT (73.9 months vs 59.9 months)
 

Progression-Free Survivali:
Delaying the Spread of Cancer

ERLEADA® (apalutamide) nmCRPC clinical study results

ERLEADA® and PSA response*

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Nearly 2/3 of men taking ERLEADA® + ADT lowered their PSA (prostate-specific antigen) by 90% at 12 months vs none taking placebo + ADT (61% vs 0%).

*PSA response to treatment with ERLEADA® is still being studied. The relationship between ERLEADA® and PSA is not fully known.

ADT: Androgen deprivation therapy (ADT) includes medical or surgical treatment that lowers testosterone.

Median: The middle number in a set of numbers. For 50% of people, this value was larger, and for 50% of people, it was smaller.

nmCRPC: Non-metastatic castration-resistant prostate cancer (nmCRPC) is prostate cancer that HAS NOT SPREAD to other parts of the body and NO LONGER responds to medical or surgical treatment that lowers testosterone.

Placebo: Pronounced “pluh-see-bow”: a pill that looks like “real” medicine but contains nothing to affect health.

Progression-free survival: Length of time patients lived without their prostate cancer spreading to local or distant parts of the body or death.

Prostate-specific antigen (PSA): A protein made by the prostate and found in the blood. Those with prostate cancer may have PSA blood levels that are higher than normal.

Side effects

ERLEADA® may cause serious side effects including:

  • chest pain or discomfort at rest or with activity
  • shortness of breath
  • numbness or weakness of the face, arm, or leg, especially on one side of the body
  • trouble talking or understanding
  • trouble seeing in one or both eyes
  • dizziness, loss of balance or coordination, or trouble walking
  • severe rash or rash that continues to get worse
  • fever or flu-like symptoms
  • swollen lymph nodes
  • blisters or sores in the mouth, throat, nose, eyes, or genital area
  • blistering or peeling of the skin
  • shortness of breath
  • cough
  • fever

The most common side effects of ERLEADA® include:

Tired icon

feeling very tired

Joint pain icon

joint pain

Severe skin reactions icon

rash

Decreased appetite icon

decreased appetite

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fall

Weight Loss icon

weight loss

Weight Loss icon

weight loss

Hypertension icon

high blood pressure

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hot flash

Diarrhea

diarrhea

Fracture icon

fracture

Your healthcare provider may reduce your dose, temporarily stop, or permanently stop treatment with ERLEADA® if you have certain side effects.

ERLEADA® may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. Do not donate sperm during treatment with ERLEADA® and for 3 months after the last dose of ERLEADA®.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ERLEADA®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

ERLEADA® + ADTi work together to lower androgensi
that can help fuel prostate cancer

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Patient Brochure icon

View the ERLEADA® Patient Brochure

Learn more about ERLEADA® and what to expect from treatment, as well as information about available savings and support.

Questions to ask your doctor

Always remember that your healthcare team should be your main source of treatment direction and information. An open and honest conversation can lead to a better treatment experience.

ERLEADA® (apalutamide) patient talking to their doctorERLEADA® (apalutamide) patient talking to their doctor
Here are some questions to help you get started:
  • What are the treatment options that may help me reach my goals?
  • Are there any nonchemotherapy options?
  • What are my options if I have trouble swallowing tablets whole?
  • Will adding a treatment to ADT help me live longer?
  • What are the side effects of adding a treatment to ADT?
  • Are there resources to help me understand insurance and how much I may pay for medication?
  • What will my quality of life be if we add a treatment to ADT?
Doctor Discussion Guide icon

Start the conversation with your doctor about ERLEADA®. Download or print our discussion guide to bring these questions and other talking points to your next appointment.