Efficacy in mCSPC

ERLEADA® is the FIRST AND ONLY AR inhibitor to report overall survival over ADT alone for patients with mCSPC in FDA-approved labeling

Dual primary endpoints:

In patients with mCSPC:

ERLEADA® + ADT reduced the risk of death by 33% vs placebo + ADT1

Overall Survival*

Median follow-up time was 22.7 months.2

*Overall survival was defined as the time from randomization to the date of death from any cause.2

ERLEADA® + ADT demonstrated superior rPFS vs placebo + ADT

ERLEADA® + ADT reduced the risk of radiographic progression or death by 52% vs placebo + ADT1

Median rPFS was not estimable with ERLEADA® + ADT vs 22.1 months with placebo + ADT1

Radiographic Progression-Free Survival (rPFS)

At 2 years, 68.2% of patients in the ERLEADA® + ADT arm were alive and without radiographic progression vs 47.5% of patients in the placebo + ADT arm2

rPFS was based on investigator assessment and was defined as time from randomization to radiographic disease progression or death. Radiographic disease progression was defined by identification of 2 or more new bone lesions on a bone scan with confirmation (Prostate Cancer Working Group 2 criteria) and/or progression in soft tissue disease.1

ERLEADA® demonstrated consistent results in these prespecified patient subgroups1

High volume of disease was defined as metastases involving the viscera with 1 bone lesion or the presence of 4 or more bone lesions, at least 1 of which must be in a bony structure beyond the vertebral column and pelvic bones.1

Secondary endpoint:

ERLEADA® significantly delayed chemotherapy initiation

ERLEADA® + ADT reduced the risk of initiation of cytotoxic chemotherapy by 61% vs placebo + ADT1

Time to Initiation of Cytotoxic Chemotherapy§2,3

§Time to cytotoxic chemotherapy was defined as the time from randomization to initiation of cytotoxic chemotherapy.2

ADT = androgen deprivation therapy; AR = androgen receptor; CI = confidence interval; FDA = US Food and Drug Administration; HR = hazard ratio; mCSPC = metastatic castration-sensitive prostate cancer; TITAN = Targeted Investigational Treatment Analysis of Novel Antiandrogen.

References

1. ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

2. Chi KN, Agarwal N, Bjartell A, et al; for the TITAN Investigators. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381(1):13-24.

3. Data on file. Janssen Biotech, Inc.