ASCO 2019: Important prostate cancer findings for Janssen's Erleada

US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Pharmaceutical companies presented positive findings from the investigational Phase III TITAN study, which showed the addition of Erleada (apalutamide) to androgen deprivation therapy (ADT) compared with placebo plus ADT significantly improved the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The study included patients with mHSPC regardless of extent of disease or prior docetaxel treatment history. Results were presented in an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, and simultaneously published online in The New England Journal of Medicine.

Apalutamide plus ADT significantly extended OS compared to placebo plus ADT with a 33% reduction in the risk of death (HR=0.67; 95% CI, 0.51-0.89; P=0.0053). In both study arms, median OS was not reached. Apalutamide plus ADT also significantly improved rPFS compared to placebo plus ADT with a 52% reduction in risk of radiographic progression or death compared to placebo plus ADT (HR=0.48; 95% CI, 0.39-0.60; P<0.0001). The median rPFS was 22.1 months for placebo plus ADT and not reached for apalutamide plus ADT. The two-year OS rates, after a median follow up of 22.7 months, were 82% for apalutamide plus ADT compared to 74 percent for placebo plus ADT.