Efficacy in nmCRPC
In patients with non-metastatic CRPC:
ERLEADA® + ADT improved median metastasis-free survival (MFS) by 2 YEARS vs placebo + ADT1
HR=0.28; 95% CI: 0.23, 0.35; P<0.0001
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
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; CI = confidence interval; CRPC = castration-resistant prostate cancer; HR = hazard ratio; nmCRPC = non-metastatic castration-resistant prostate cancer; PSA = prostate-specific antigen; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509.
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. U.S. Food and Drug Administration. Drug Approval Package: ERLEADA® (apalutamide). SPARTAN Clinical Study Report. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/Erleada_210951_t.... Accessed September 24, 2019.
4. Smith MR, Saad F, Rathkopf DE, et al. Relationship of time to metastasis (TTM) and site of metastases in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC): results from the phase 3 SPARTAN trial [abstract 5033]. J Clin Oncol. 2018;36(15_suppl).