Johnson & Johnson (J&J) has announced results from the final analysis of the phase 3 PROTEUS study showing that Erleada (apalutamide) plus hormone therapy (androgen deprivation therapy) significantly improved key short- and long-term clinical outcomes, versus placebo plus hormone therapy, for patients with high-risk localised or locally advanced disease.
The trial met both primary endpoints. Patients treated with apalutamide plus hormone therapy were nine times more likely to have little to no cancer remaining at the time of surgery compared with hormone therapy alone (8.9% vs. 1.0% pathologic complete response/minimal residual disease). The combination also reduced the risk of developing metastasis or death by 20% and extended the time before patients required subsequent therapy to more than six years.
Henar Hevia, Senior Director, EMEA Therapeutic Area Head, Oncology at Johnson & Johnson, said: “Our ambition is to continue advancing therapies into earlier lines of treatment, where intervention may have the greatest potential to alter the course of disease,” said “By building on the established role of surgery with innovative systemic approaches, like apalutamide plus hormone therapy, we are helping drive a more proactive treatment strategy, tailored to patients’ evolving needs and ultimately aimed at delivering more durable outcomes.”
Surgery to remove the prostate (radical prostatectomy) is one of the standard treatments for patients with high-risk localised or locally advanced disease, alongside radiation therapy. Yet nearly half of patients who undergo curative-intent surgery will see their cancer return, requiring additional treatment and moving beyond the point where cure is possible. Additional therapies are often used only after the cancer has spread, missing a critical window to intervene earlier and improve long-term outcomes.
Yusri Elsayed, Global Therapeutic Area Head, Oncology at Johnson & Johnson, commented: “These findings point to a new potential way of treating patients with high-risk localised or locally advanced prostate cancer. We are now seeing the impact of apalutamide when used earlier, alongside surgery. As the first therapy in its class to show benefit in this setting, the data reinforces apalutamide’s differentiated profile and the need to move beyond a surgery‑only approach to treating earlier and improving long‑term outcomes.”
These findings will be presented in a plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Oral Abstract #LBA1) and published simultaneously in The New England Journal of Medicine.