~40% of PBO-treated patients crossed over to receive open- label APA at unblinding.
IPCW sensitivity analysis for crossover effect was prespecified in the statistical analysis plan.
IPCW, Inverse probability censoring weighted (sensitivity analysis); ITT, intent to treat.
IPCW method, Cale SR et aI., compute methods programs blomed. 2004; 75:45-49.
ADT, androgen deprivation therapy; HRQoL, health-related quality of life; mHSPC, metastatic hormone-sensitive prostate cancer; OS, overall survival; PSA, prostate-specific antigen.
*ERLEADA® is also indicated in adult men for the treatment of nori-metastatic castration-resistant prostate cancer (CRPC) who are at high risk of developing metastatic disease (PSA doubling time of 10 months, despite ADT).1
1Median OS was not reached in the ERLEADA® arm (HR: 0.65;95% CI:0.53-0.79; p<0.0001).3
1. ERLEADA® . Summary of Product Characteristics. Janssen-Cilag. Available at . Accessed: February 2021.
2. Chi KN, et al. N Engl J Med. 2019;81(1):13–24.
3. Chi KN, et al. Final analysis results from TITAN: a phase 3 study of apalutamide (APA) vs placebo(PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receivingandrogen deprivation therapy (AOT). Available at: . Accessed: February 2021.