Johnson & Johnson reports peri‑operative apalutamide plus ADT cuts recurrence risk by 62% in high‑risk prostate cancer
Johnson & Johnson disclosed results of the Phase 3 PROTEUS substudy, which compared peri‑operative apalutamide with androgen deprivation therapy (ADT) against radical prostatectomy alone in high‑risk localized or locally advanced prostate cancer. In 408 patients, the combination reduced the risk of disease recurrence or death by 62% (hazard ratio 0.38) and lowered metastasis‑free survival risk by 51% versus surgery. At three years, 63% of patients on the regimen remained event‑free compared with 41.4% on surgery alone.
Why it matters
The company says the data support expanding apalutamide into earlier‑stage disease, which could lead to regulatory submissions and broaden its market beyond advanced prostate cancer. Investors should watch for potential label extensions and related revenue upside.
Key facts
- 1The substudy enrolled 408 patients with high‑risk localized or locally advanced prostate cancer. stocktitan.net
- 2Apalutamide plus ADT reduced the risk of recurrence or death by 62% versus surgery alone (hazard ratio 0.38, 95% CI 0.26‑0.55, p<0.0001). prnewswire.com
- 3Metastasis‑free survival risk was 51% lower with the regimen (hazard ratio 0.49). stocktitan.net
- 4Median event‑free survival was not reached with apalutamide plus ADT, compared with 19.1 months for surgery alone. stocktitan.net
- 5At three years, 63% of patients on apalutamide plus ADT remained event‑free versus 41.4% on surgery alone. stocktitan.net
- 6Grade 3‑4 treatment‑emergent adverse events occurred in 31% of the combination arm and 22% of the surgery arm. stocktitan.net
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.