ERLEADA® for Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Reference

Among all registration trials in mCSPC:

ERLEADA® is the FIRST AND ONLY AR inhibitor to achieve a 35% reduction in the risk of death vs ADT alone

(ERLEADA® + ADT vs placebo + ADT; median OS: NR vs 52.2 months; HR=0.65; 95% CI: 0.53, 0.79; P<0.0001)*1

*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

TITAN Primary Publication

Review the journal article to learn more about the study results

Accessing this article may require a subscription to The New England Journal of Medicine.


TITAN Final Analysis Publication

Review the journal article to learn more about overall survival data in the TITAN study

Accessing this article may require a subscription to the Journal of Clinical Oncology.


Exploratory Analysis:

TITAN Patient-Reported Outcomes Publication

Review the journal article to learn more about patient-reported outcomes in the TITAN study

Accessing this article may require a subscription to The Lancet Oncology.

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; NR = not reached; OS = overall survival; TITAN = Targeted Investigational Treatment Analysis of Novel Antiandrogen.

Reference

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.