How effective is Erleada (apalutamide)?

Erleada (apalutamide) is used for nonmetastatic castration-resistant prostate cancer (nmCRPC) and for metastatic, castration-sensitive prostate cancer (mCSPC).

Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC)

The SPARTAN clinical trial (NCT01946204) for nmCRPC studied how effective Erleada was at increasing the time before prostate cancer had spread to other parts of the body, or time before death occurred. Patients who were in the apalutamide group had a median metastasis-free survival 24.3 months longer before cancer spread to other parts of the body or before death occurred, when compared to the placebo group.

The median metastasis-free survival for nmCRPC was:

• 40.5 months in the apalutamide group
• 16.2 months in the placebo group
• This means the apalutamide group of patients lived a median of 24.3 months longer without progressing to metastasis or death (40.5 -16.2= 24.3 months).

Metastatic, Castration-Sensitive Prostate Cancer (mCSPC).

The TITAN clinical trial (NCT02489318) for mCSPC looked at whether the addition of apalutamide to androgen-deprivation therapy (ADT) would increase radiographic progression–free survival and also increase overall survival, when compared with placebo plus ADT. Radiographic progression–free survival is the length of time before imaging shows cancer has progressed or death occurs.

Radiographic progression–free survival

The results of the TITAN trial show that at 24 months the percentage of mCSPC patients with radiographic progression–free survival was:

• 68.2% in the apalutamide + ADT group
• 47.5% in the placebo + ADT group
• Meaning the apalutamide + ADT group had 20.7% more patients who reached 24 months without radiographic progression of their cancer. (68.2%-47.5%=20.7%)

Overall survival

Effectiveness of apalutamide on mCSPC was also measured by overall survival in each group after 24 months:

• 82.4% in the apalutamide + ADT group were still alive
• 73.5% in the placebo + ADT group were still alive
• This means that after 24 months there were more patients surviving in the apalutamide + ADT group compared to the placebo + ADT group.

Bottom line:

• Nonmetastatic castration-resistant prostate cancer (nmCRPC) patients on apalutamide lived a median of 24.3 months longer without progressing to metastasis or death (40.5 - 16.2 = 24.3 months) when compared to the placebo group.
• A larger percentage of metastatic, castration-sensitive prostate cancer (mCSPC) patients on apalutamide + ADT reached 24 months without radiographic progression of their cancer, compared to the placebo + ADT group.
• More of the metastatic, castration-sensitive prostate cancer (mCSPC) patients in the apalutamide + ADT treatment group were still alive after 24 months, compared to placebo + ADT group.

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