GIVE PATIENTS WITH mCSPC or nmCRPC MORE TIME IN THEIR RIGHTFUL PLACE
LET PROVEN EFFICACY REIGN1ERLEADA® + ADT demonstrated superior OS vs ADT alone in men with mCSPC (35% reduction in the risk of death; HR=0.65, CI: 0.53, 0.79; Median OS: NR vs 52.2 months; Median follow-up time: 44.0 months).1-3
Primary Analysis: Median OS: NE vs NE; HR=0.67; 95% CI: 0.51, 0.89; P=0.0053. Median follow-up time was 22.7 months.1,2
Extends OS for men with mCSPC or nmCRPC1-6
Efficacy in the TITAN study
Dual primary endpoint, final analysis
ERLEADA® + ADT DEMONSTRATED SUPERIOR OS IN MEN WITH mCSPC VS ADT ALONE1-3
Kaplan-Meier Analysis of OS (TITAN)2
Median follow-up time was 44.0 months.1
The survival rate at 48 months was 65.1% for ERLEADA® + ADT patients vs 51.8% for placebo + ADT patients.1 OS improved regardless of Gleason score, age, high- or low-disease volume, and metastasis stage at diagnosis. The TITAN primary analysis results: Median OS: NE vs NE; HR=0.67; 95% CI: 0.51, 0.89; P=0.0053. Median follow-up time was 22.7 months.1,2
Review the final OS results of the TITAN study published in the Journal of Clinical Oncology
Dual primary endpoint, primary analysis
ERLEADA® + ADT DEMONSTRATED SUPERIOR rPFS VS ADT ALONE2,3,5
rPFS in Intent-to-Treat mCSPC Population (TITAN)
Median follow-up time was 22.7 months.5
ERLEADA® + ADT improved rPFS vs placebo + ADT in a range of patient types with mCSPC.2,4 rPFS improved regardless of high- or low-volume disease, prior docetaxel use, or Gleason score at diagnosis.2,5
Efficacy in the SPARTAN study
Primary endpoint, primary analysis
ERLEADA® + ADT DEMONSTRATED A 2-YEAR IMPROVEMENT IN MEDIAN MFS VS ADT ALONE2,6
MFS in Patients With nmCRPC (SPARTAN)
Median follow-up was 20.3 months.6
Secondary endpoint, final analysis
ERLEADA® + ADT SIGNIFICANTLY IMPROVED OS IN MEN WITH nmCRPC VS ADT ALONE2,4
OS in Patients With nmCRPC (SPARTAN)
Median follow-up was 52.0 months.4
Review the final OS results of the SPARTAN study published in European Urology
See the PSA data
IMPORTANCE OF PSA EXPLORATORY DATA FROM THE TITAN AND SPARTAN CLINICAL TRIALS AND REAL-WORLD DATA
Limitations: These data are from exploratory endpoints in clinical trials, post hoc analyses, and real-world studies and are not included in the full ERLEADA® Prescribing Information. PSA should be viewed in the context of patient management and the overall physical condition and clinical course of the patient. PSA responses are not reported in product labeling because they are not validated biomarkers.
Efficacy in the TITAN study
TIME TO PSA PROGRESSION: ERLEADA® + ADT VS ADT ALONE
Median follow-up of 44.0 months.1
*Time to PSA progression was defined as the time from randomization to PSA progression, according to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria. For patients who experienced a decline in PSA from baseline, PSA progression was defined as the first PSA increase that was ≥25% and ≥2 ng/mL above the nadir, which was confirmed by a second value obtained 3 or more weeks later. For patients who did not experience a decline in PSA from baseline, PSA progression was defined as a PSA increase that was ≥25% and ≥2 ng/mL above the baseline value after 12 weeks.1,8
Time to PSA progression and PSA response rate are not reported in product labeling because they are not validated biomarkers. PSA evaluation should be viewed in the context of patient management and the overall physical condition and clinical course of the patient.9
PSA Response at 3 Months
PSA Response at 12 Months
PSA-OS Relationship in TITAN: PSA90 With ERLEADA® + ADT
PSA-OS Relationship in TITAN: PSA Undetectable With ERLEADA® + ADT
REAL-WORLD PSA50 AND PSA90 RESPONSES WERE SIMILAR TO THOSE SEEN IN THE TITAN STUDY
| PSA50 | PSA90 | |
|---|---|---|
| % of mCSPC patients who achieved PSA responses | ||
| Real-world Clinical Data (>8 Weeks) | 86.7% | 73.5% |
| TITAN (At Any Time) mCSPC | 90% | 72% |
Clinical real-world data collected as part of routine clinical care from 69 urology sites in the United States (study period: February 2017 - March 5, 2021). PSA responses to ERLEADA®were observed in real-world data >8 weeks after initiation of ERLEADA® and in the TITAN study at any time after starting treatment. Responses were evaluated in a retrospective longitudinal cohort study of patients with mCSPC (n=260) or nmCRPC (n=313) who were treated with ERLEADA®.11
†This real-world analysis relied on clinical data that may contain inaccuracies or omissions (eg, diagnosis dates, treatment start dates, and other variables) and does not capture any diagnoses, medical services, or prescription fills obtained outside of the urology practice. The database represents the community urology setting and might not be representative of the entire population of ERLEADA®initiators in the United States, which may limit the generalizability of the study.11
PSA RESPONSE IN BLACK AND NON-BLACK PATIENTS TREATED WITH ERLEADA® WAS CONSISTENT WITH TITAN STUDY DATA
Clinical real-world data collected as part of routine clinical care from 69 urology sites in the United States (study period: February 2017 - March 5, 2021). Responses were evaluated in a retrospective longitudinal cohort study of patients with mCSPC (n=260) or nmCRPC (n=313) who were treated with ERLEADA®.11
‡This real-world analysis relied on clinical data that may contain inaccuracies or omissions (eg, diagnosis dates, treatment start dates, and other variables) and does not capture any diagnoses, medical services, or prescription fills obtained outside of the urology practice. The database represents the community urology setting and might not be representative of the entire population of ERLEADA® initiators in the United States, which may limit the generalizability of the study.11
§PSA response was defined as the first decline for a follow-up PSA value of 90% or more from the most recent PSA value within 13 weeks of the index date.11
IMPORTANCE OF PSA EXPLORATORY DATA FROM THE TITAN AND SPARTAN CLINICAL TRIALS AND REAL-WORLD DATA
Limitations: These data are from exploratory endpoints in clinical trials, post hoc analyses, and real-world studies and are not included in the full ERLEADA® Prescribing Information. PSA should be viewed in the context of patient management and the overall physical condition and clinical course of the patient. PSA responses are not reported in product labeling because they are not validated biomarkers.
Efficacy in the SPARTAN study
TIME TO PSA PROGRESSION: ERLEADA® + ADT VS ADT ALONE
Median follow-up time was 52.0 months.4
*Time to PSA progression: Median NE vs 3.7 months; HR=0.07; 95% CI: 0.06, 0.09.4
†Time to PSA progression was defined as the time from randomization to PSA progression, according to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria. For patients who experienced a decline in PSA from baseline, PSA progression was defined as the first PSA increase that was ≥25% and ≥2 ng/mL above the nadir, which was confirmed by a second value obtained 3 or more weeks later. For patients who did not experience a decline in PSA from baseline, PSA progression was defined as a PSA increase that was ≥25% and ≥2 ng/mL above the baseline value after 12 weeks.4,8
PSA response: 38% of patients in the ERLEADA® + ADT arm achieved a confirmed PSA level ≤0.2 ng/mL vs no patients in the placebo + ADT arm.4
Time to PSA progression and PSA response rate are not reported in product labeling because they are not validated biomarkers. PSA evaluation should be viewed in the context of patient management and the overall physical condition and clinical course of the patient.9
PSA Response at 3 Months
PSA Response at 12 Months
PSA-OS Relationship in SPARTAN: PSA90 With ERLEADA® + ADT
PSA-OS Relationship in SPARTAN: PSA Undetectable With ERLEADA® + ADT
REAL-WORLD PSA50 AND PSA90 RESPONSES WERE SIMILAR TO THOSE SEEN IN THE SPARTAN STUDY
| PSA50 | PSA90 | |
|---|---|---|
| % of nmCRPC patients who achieved PSA responses | ||
| Real-world Clinical Data (>8 Weeks) | 82.3% | 66.0% |
| SPARTAN (At Any Time) nmCRPC | 90% | 62% |
Clinical real-world data collected as part of routine clinical care from 69 urology sites in the United States (study period: February 2017 - March 5, 2021). PSA responses to ERLEADA®were observed in real-world data >8 weeks after initiation of ERLEADA® and in the SPARTAN study at any time after starting treatment. Responses were evaluated in a retrospective longitudinal cohort study of patients with mCSPC (n=260) or nmCRPC (n=313) who were treated with ERLEADA®.11
†This real-world analysis relied on clinical data that may contain inaccuracies or omissions (eg, diagnosis dates, treatment start dates, and other variables) and does not capture any diagnoses, medical services, or prescription fills obtained outside of the urology practice. The database represents the community urology setting and might not be representative of the entire population of ERLEADA®initiators in the United States, which may limit the generalizability of the study.11
PSA RESPONSE IN BLACK AND NON-BLACK PATIENTS TREATED WITH ERLEADA® WAS CONSISTENT WITH SPARTAN STUDY DATA
Clinical real-world data collected as part of routine clinical care from 69 urology sites in the United States (study period: February 2017 - March 5, 2021). Responses were evaluated in a retrospective longitudinal cohort study of patients mCSPC (n=260) or nmCRPC (n=313) who were treated with ERLEADA®.11
§This real-world analysis relied on clinical data that may contain inaccuracies or omissions (eg, diagnosis dates, treatment start dates, and other variables) and does not capture any diagnoses, medical services, or prescription fills obtained outside of the urology practice. The database represents the community urology setting and might not be representative of the entire population of ERLEADA®initiators in the United States, which may limit the generalizability of the study.11
||PSA response was defined as the first decline for a follow-up PSA value of 90% or more from the most recent PSA value within 13 weeks of the index date.11
Established safety profiles in the TITAN and SPARTAN studies
ADT = androgen deprivation therapy; CI = confidence interval; GnRH = gonadotropin-releasing hormone; HR = hazard ratio; mCSPC = metastatic castration-sensitive prostate cancer; MFS = metastasis-free survival; NE = not estimable; nmCRPC = non-metastatic castration-resistant prostate cancer; NR = not reached; OS = overall survival; PSA = prostate-specific antigen; rPFS = radiographic progression-free survival; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509; TITAN = Targeted Investigational Treatment Analysis of Novel Anti-androgen.
REFERENCES:
- 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. J Clin Oncol. 2021;39(20):2294-2303.
- ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
- A study of apalutamide (JNJ-56021927, ARN-509) plus androgen deprivation therapy (ADT) versus ADT in participants with mCSPC (TITAN). ClinicalTrials.gov identifier: NCT02489318. Updated February 15, 2023. Accessed April 30, 2024. https://clinicaltrials.gov/ct2/show/NCT02489318?term=apalutamide&cond=prostate+cancer&draw=4&rank=22
- Smith MR, Saad F, Chowdhury S, et al. Apalutamide and overall survival in prostate cancer. Eur Urol. 2021;79(1):150-158.
- Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381:13-24.
- Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378(15):1408-1418.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 17, 2024. To view the most recent and complete version of the guideline, go to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
- Scher HI, Halabi S, Tannock I, et al; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008;26(7):1148-1159.
- Crawford ED, Bennett CL, Andriole GL, Garnick MB, Petrylak DP. The utility of prostate-specific antigen in the management of advanced prostate cancer. BJU Int. 2013;112(5):548-560.
- Chi KN, Saad F, Choudhury S, et al. Prostate-specific antigen kinetics in patients with advanced prostate cancer treated with apalutamide: results from the TITAN and SPARTAN studies. Poster presented at the American Urological Association Annual Meeting; September 10-13, 2021; Las Vegas, Nevada.
- Durkin M, Pilon D, Rossi C, et al. Prostate-specific antigen response among black and non-black patients with advanced prostate cancer treated with apalutamide in a urology setting. J Clin Oncol. 2021;39(28_suppl):124.
- Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for metastatic, castration-sensitive prostate cancer. Protocol. N Engl J Med. 2019;381:13-24. Accessed April 30, 2024. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1903307/suppl_file/nejmoa1903307_protocol.pdf
- U.S. Food and Drug Administration. Drug Approval Package: ERLEADA® (apalutamide). SPARTAN Clinical Study Report. Accessed April 30, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/rev_210951_arn-509-003_CSR_Redacted.pdf
- 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).