Erleada shows clinically-meaningful improvement in prostate cancer OS

US health care giant Johnson & Johnson (NYSE: JNJ) today released results of a landmark real-world head-to-head study showing that Erleada (apalutamide) provided a statistically-significant overall survival benefit at 24 months (23% reduction of risk of death) compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC).

Head-to-head, randomized and controlled Phase III studies have been the gold standard for comparing the effectiveness of oncology medicines, but no such studies have evaluated androgen receptor pathway inhibitors (ARPIs), said J&J.

The study applied US Food and Drug Administration (FDA) real-world evidence guidance and employed robust methodology, data sources and a large, diverse cohort to ensure validity of its findings.