ASCO 2026: J&J shows Erleada can break prostate cancer treatment mold in high‑risk localized disease

Johnson & Johnson's prostate cancer drug Erleada (apalutamide) has shown a 20% reduction in the relative risk of disease progression and death in a phase 3 trial (PROTEUS) that was a highlight of the 2026 ASCO Annual Meeting.

In the PROTEUS trial, combining Erleada with androgen deprivation therapy (ADT) before and after prostate surgery for high‑risk localized cancer increased the chance of having no cancer remaining at surgery by about nine‑fold and lengthened the time until additional therapy was needed.

The results are being described as breaking a decades‑old treatment mold because they support adding systemic drug therapy (Erleada plus ADT) around the time of surgery, rather than using surgery alone in high‑risk prostate cancer.

Erleada is already approved for two advanced stages of prostate cancer; the PROTEUS data now position it to potentially shift the standard of care to a perioperative regimen for high‑risk localized disease, despite higher rates of serious adverse events and treatment‑related discontinuations.

Sources:

ERLEADA - ACIS Study - J&J Medical Connect

ASCO 2026: Potential new targeted treatment option for people with ...

[PDF] united states district court

ASCO ‘26: Bispecifics vs. ADCs, a ‘RAS' revolution and a step change in prostate cancer

Perioperative Apalutamide Shifts Standard in Localized ...

ERLEADA - LIBERTAS Study - J&J Medical Connect

Janssen Announces Treatment with ERLEADA ...

Johnson & Johnson's Phase 3 prostate cancer study ... - alphai

[PDF] Prostate Cancer ERLEADA® (apalutamide) Plenary Session May

J&J gets first-of-its-kind prostate cancer approval - BioPharma Dive

Johnson & Johnson Highlights Ambition to Transform the Treatment of Prostate

J&J Wins FDA Nod for Erleada, the First Drug for Nonmetastatic ...

[PDF] Johnson & Johnson ushers in the next wave of innovation in cancer ...

Johnson & Johnson's Erleada trial stops early on good news, setting up case for new prostate cancer nod