TO PUSH BACK ON PROGRESSION
*TITAN final analysis data are not currently reported in the ERLEADA® Prescribing Information. The following TITAN primary analysis results are included in the ERLEADA® Prescribing Information: Median OS: NE vs NE; HR=0.67; 95% CI: 0.51, 0.89; P=0.0053.2
Review the results of the TITAN study published in The New England Journal of Medicine.
Final analysis publication
Review the final overall survival results of the TITAN study published in the Journal of Clinical Oncology.
FIRST AND ONLY AR inhibitor to
improve median MFS by 2 YEARS in nmCRPC
(ERLEADA® + ADT vs placebo + ADT; 40.5 months vs 16.2 months; HR=0.28; 95% CI: 0.23, 0.35; P<0.0001)2
FIRST AND ONLY therapy to improve median OS by 14 MONTHS in nmCRPC
(ERLEADA® + ADT vs placebo + ADT; 73.9 months [6.2 years] vs 59.9 months [5 years]; HR=0.78; 95% CI: 0.64, 0.96; P=0.0161)†2
Review the results of the SPARTAN study published in The New England Journal of Medicine.
Final analysis publication
Review the final overall survival results of the SPARTAN study published in European Urology.
Patient-reported outcomes publication
Review patient-reported outcomes in the SPARTAN study published in The Lancet Oncology.
The articles above may only be available to subscribers of the respective journals. To access this content, you may have to sign in using your personal or institutional credentials. If you are not registered or a member of these journals, then you may need to purchase the articles through their sites.
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‡All patients who enrolled in the TITAN study started ADT for mCSPC ≤6 months prior to randomization.3
§In the SPARTAN study, conventional imaging (technetium-99m bone scans and CT scans) was used to confirm that patients were non-metastatic at screening for inclusion. Patients with pelvic lymph nodes <2 cm in short axis (N1) located below the iliac bifurcation at screening were allowed in the study. All patients in SPARTAN had a PSA doubling time ≤10 months at study entry.2,4
ADT = androgen deprivation therapy; AR = androgen receptor; CI = confidence interval; CT = computed tomography; HR = hazard ratio; mCSPC = metastatic castration-sensitive prostate cancer; MFS = metastasis-free survival; nmCRPC = non-metastatic castration-resistant prostate cancer; NR = not reached; OS = overall survival; PSA = prostate-specific antigen; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509; TITAN = Targeted Investigational Treatment Analysis of Novel Antiandrogen.
1. Chi KN, Chowdhury S, Bjartell A, et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN study [published online April 29, 2021]. J Clin Oncol. doi.org/10.1200/JCO.20.03488
2. ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
3. 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.
4. 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.