Johnson & Johnson announces ERLEADA® (apalutamide) treatment before and after surgery reduces risk of recurrence or death by 62% versus surgery alone in high-risk prostate cancer
Key Highlights
- ➤EFS improved 62% versus surgery alone, reducing recurrence or death risk (HR 0.38)
- ➤MFS improved numerically, with a 51% lower risk of metastasis or death
- ➤Three-year freedom from subsequent treatment doubled with perioperative apalutamide plus ADT
- ➤PROTEUS substudy included 408 patients with high-risk localized or locally advanced prostate cancer
Expert Statements
Alberto Briganti, Professor of Urology and Urologic Surgeon at IRCCS San Raffaele Hospital, Milan
“Radical prostatectomy has long been a cornerstone of curative-intent treatment for high-risk localized prostate cancer, yet recurrence remains a concern for patients with aggressive disease.”
Alberto Briganti, Professor of Urology and Urologic Surgeon at IRCCS San Raffaele Hospital, Milan
“In this substudy, median event-free survival was 19.1 months with surgery alone, highlighting the challenges these patients continue to face despite treatment intended to cure their cancer.”
Alberto Briganti, Professor of Urology and Urologic Surgeon at IRCCS San Raffaele Hospital, Milan
“The reduction in the risk of recurrence and metastases after radical prostatectomy seen with apalutamide plus androgen deprivation therapy suggests we may be able to build on surgery and help more patients achieve lasting disease control.”
Courtney Bugler, President and CEO of ZERO Prostate Cancer
“For people with high-risk early prostate cancer, finishing surgery doesn't necessarily mean the uncertainty is over.”
Courtney Bugler, President and CEO of ZERO Prostate Cancer
“The possibility of recurrence can weigh heavily on patients and their families, even as they try to move forward with their lives.”
Courtney Bugler, President and CEO of ZERO Prostate Cancer
“The possibility of helping more people remain free from disease recurrence, and potentially avoid or delay additional treatment, is incredibly meaningful.”
Courtney Bugler, President and CEO of ZERO Prostate Cancer
“More time without another treatment can mean more time focused on family, work and life, rather than what comes next for their cancer.”
Yusri Elsayed, Global Therapeutic Area Head, Oncology, Johnson & Johnson
“The primary PROTEUS study showed the potential of treating high-risk prostate cancer earlier with apalutamide plus androgen deprivation therapy.”
Yusri Elsayed, Global Therapeutic Area Head, Oncology, Johnson & Johnson
“We designed this substudy to take that evidence further by evaluating the regimen against surgery alone, a longstanding standard of care for these patients.”
Yusri Elsayed, Global Therapeutic Area Head, Oncology, Johnson & Johnson
“These findings provide important additional insight into what this approach could mean for patients and reinforce why we continue to investigate ways to improve outcomes earlier in the course of disease.”
Johnson & Johnson announces ERLEADA® (apalutamide) treatment before and after surgery reduces risk of recurrence or death by 62% versus surgery alone in high-risk prostate cancer PR Newswire
* New substudy results showed a 51% lower estimated risk of metastasis or death over time with perioperative apalutamide plus ADT compared with immediate surgery * Twice as many patients remained free from subsequent treatment at three years with perioperative apalutamide plus ADT compared with surgery alone * Results evaluated outcomes versus surgery alone, building on the primary results presented at ASCO 2026 NEW BRUNSWICK, N.J., Oct. 24, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new results from the Phase 3 PROTEUS substudy that directly compared the investigational use of apalutamide plus androgen deprivation therapy (ADT), given for six months before and after surgery, with radical prostatectomy alone in patients with high-risk localized or locally advanced prostate cancer. The apalutamide plus ADT regimen reduced the risk of disease recurrence or death by 62 percent compared with surgery alone. The regimen also showed a numerical improvement in metastasis-free survival (MFS), with a 51 percent lower risk of metastasis or death. Patients receiving apalutamide plus ADT also went longer before needing subsequent therapy.(1)
Get started
Create a free account to read the full story.