Clinical
Study
Results With ERLEADA

ERLEADA Helps Men Live Longer and Lowers PSA

ERLEADA + ADT vs placebo + ADT

1,052

men with mCSPC

525

men received ERLEADA + ADT

527

men received placebo + ADT

In this study, men either received ERLEADA (apalutamide) 240 mg once daily or placebo. All men in the study received ADT. The 4-year study examined how long a patient’s cancer remained stable without getting worse.

ERLEADA Helped Men Live Longer

ERLEADA + ADT

^~7/10 WERE ALIVE

On ADT alone

5.5/10 WERE ALIVE

ERLEADA + ADT was evaluated for efficacy and safety vs placebo + ADT in patients with mCSPC.

Median (middle) follow-up was 44 months.

ERLEADA Reduced the Risk of Prostate Cancer Getting Worse

52%

reduction in the risk of progression

ERLEADA + ADT reduced the risk of prostate cancer getting worse by 52% vs placebo + ADT.*

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

ERLEADA Helped Men Achieve a Zero PSA Level^†

>2X as many men achieved zero PSA^† vs placebo + ADT

ERLEADA + ADT lowered PSA in more than 2X as many men vs ADT alone (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 Chemotherapy

61%

reduction in the risk of beginning chemotherapy

ERLEADA + ADT reduced the risk of beginning chemotherapy by 61% vs placebo + ADT.^§

^§Median (middle) data have 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.

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.

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,” this is a pill that looks like a “real” medicine but contains nothing to affect health.

PSA: Prostate-specific antigen.

ERLEADA + ADT vs placebo + ADT

1,207

men with nmCRPC

806

men received ERLEADA + ADT

401

men received placebo + ADT

In this study of 1,207 men with nmCRPC, ERLEADA (apalutamide) + ADT was compared with placebo + ADT. 806 men received 240 mg of ERLEADA + ADT, while 401 men received placebo + ADT. All men in the study received ADT. The 4-year study examined how long a patient’s cancer remained stable without getting worse.

ERLEADA Helped Men Live Longer Without the Spread of Prostate Cancer

ERLEADA + ADT

40.5 MONTHS

Placebo + ADT

16.2 MONTHS

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

Progression-free survival: Delaying cancer getting worse

Also in this clinical study, ERLEADA + ADT delayed the spread of cancer to other parts of the body or death by a median of 25.8 months compared with placebo + ADT.

ERLEADA and PSA Response*