Efficacy

The power to push back on progression:

ERLEADA™ + ADT improved median metastasis-free survival (MFS) by 2 YEARS vs placebo + ADT1

Consistent results in metastasis-free survival (MFS) were observed across patient subgroups, including1:

  • PSA doubling time (≤6 months or >6 months)
  • Use of a prior bone-sparing agent (Yes or No)
  • Locoregional disease (N0 or N1)

*Metastasis-free survival was defined as the time from randomization to the time of first evidence of blinded independent central review-confirmed distant metastasis, defined as new bone or soft tissue lesions or enlarged lymph nodes above the iliac bifurcation, or death due to any cause, whichever occurred first.1

At the time of the analysis, 60.9% of patients were still on ERLEADA™ + ADT vs 29.9% of patients still on placebo + ADT2

Secondary endpoints favored the ERLEADA™ + ADT arm1

Time to metastasis was defined as the time from randomization to the time of the scan that showed first evidence of blinded independent central review-confirmed radiographically detectable bone or soft tissue distant metastasis.2,3

Progression-free survival was defined as the time from randomization to first documentation of blinded independent central review-confirmed radiographic progressive disease or death due to any cause, whichever occurred first.2,3

Overall survival data were not mature at the time of the final metastasis-free survival (MFS) analysis (24% of the required number of events).§1

§Long-term follow-up will continue to assess the overall survival data as they mature. At the time of the first interim analysis of overall survival, a total of 104 deaths had occurred in the SPARTAN study. The final overall survival analysis will be conducted after approximately 427 deaths have been reported.2,3

Secondary endpoint:

The metastasis-free survival (MFS) outcome was supported by a statistically significant improvement in time to symptomatic progression1

Time to symptomatic progression was defined as the time from randomization to documentation of any of the following (whichever occurred earlier)2,3

  • Development of a skeletal-related event: pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone
  • Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anticancer therapy
  • Development of clinically significant symptoms due to locoregional tumor progression requiring surgical intervention or radiation therapy

Examples of symptomatic progression evaluated in the SPARTAN study:

Spinal cord compression

The need for surgical intervention

The need for radiation therapy

ADT = androgen-deprivation therapy; HR = hazard ratio; PSA = prostate-specific antigen; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509.

References

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

2. Smith MR, Saad F, Chowdhury S, et al; for the SPARTAN Investigators. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418.

3. Data on file. Janssen Biotech, Inc.