Compared with patients receiving hormone therapy alone, patients were nine times more likely to havelittle to no cancer remaining in the prostate after surgery, with a 20 percent reduction in the risk of developing metastasis or death¹

Data selected to open the plenary presentation at ASCO 2026 and published in The New England Journal of Medicine

Johnson & Johnson announced results from the final analysis of the Phase 3 PROTEUS study showing the investigational use of ERLEADA^® (apalutamide) plus hormone therapy (androgen deprivation therapy), given for six months before and after prostate cancer surgery, 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.¹ 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 percent vs. 1.0 percent pathologic complete response/minimal residual disease).¹ The combination also reduced the risk of developing metastasis or death by 20 percent and extended the time before patients required subsequent therapy to more than six years.¹ 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.

The unmet need with standard treatments for patients with high-risk localised prostate cancer
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.^3,4 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.^5,6 Additional therapies are often used only after the cancer has spread, missing a critical window to intervene earlier and improve long-term outcomes.⁷

Expert perspectives on the perioperative use of apalutamide plus hormone therapy six months before and after prostate cancer surgery
“For many patients with high-risk localised prostate cancer, surgery alone may not be enough to prevent recurrence and disease progression, and many will ultimately go on to develop more advanced disease,” said Alberto Briganti, M.D., Professor of Urology and Urologic Surgeon at IRCCS San Raffaele Hospital, Milan.* “The PROTEUS findings signal the potential for a practice-changing shift, supporting a perioperative treatment approach that integrates apalutamide alongside curative-intent surgical treatment, with the potential to improve long-term outcomes and redefine how we manage patients with aggressive localised disease.”

“The PROTEUS study data reflect Johnson & Johnson’s long-standing commitment to transforming outcomes for patients across the prostate cancer journey. 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 Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson. “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.”

“These findings point to a new potential way of treating patients with high-risk localised or locally advanced prostate cancer,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “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, these data reinforce apalutamide’s differentiated profile and the need to move beyond a surgery‑only approach to treating earlier and improving long‑term outcomes.”

Detailed PROTEUS study results
PROTEUS is a Phase 3 study evaluating apalutamide, an androgen receptor pathway inhibitor, combined with hormone therapy before and after surgery in patients with newly diagnosed high-risk localised or locally advanced prostate cancer (n=2109).¹ The dual primary endpoints were the amount of cancer remaining at surgery (pathologic complete response/minimal residual disease, pCR/MRD) and how long patients lived without the cancer spreading (metastasis-free survival, MFS), both assessed by blinded independent central review.¹

At a median follow-up of 61.7 months, apalutamide plus hormone therapy met both primary endpoints. The rate of pCR/MRD was 8.9 percent with apalutamide plus hormone therapy versus 1.0 percent with hormone therapy alone (odds ratio [OR], 10.17; 95 percent confidence interval [CI], 5.27-19.64; p<0.0001).¹ Apalutamide plus hormone therapy also demonstrated a statistically significant 20 percent reduction in the risk of metastasis or death (hazard ratio [HR], 0.80; 95 percent CI, 0.67-0.96; p=0.02), with five-year rates of 78.2 percent versus 73.5 percent, respectively.^1,2 Similar MFS results were observed in investigator assessments (HR, 0.74; 95 percent CI, 0.62-0.87; p=0.0004).¹

Key secondary endpoints also showed statistically significant and clinically relevant improvement, reinforcing the benefit of the combination across multiple measures of disease control.¹ Notably, patients receiving one year of apalutamide plus hormone therapy before and after surgery went more than six years before needing subsequent therapy, compared to approximately three and a half years with hormone therapy alone (74.2 vs. 41.5 months; HR, 0.65; 95 percent CI, 0.57-0.73; p<0.0001).¹Most patients also recovered adequate testosterone levels within 8.1 months.¹ Additional benefits included a 29 percent reduction in the risk of disease recurrence or death (event-free survival; HR, 0.71; 95 percent CI, 0.63-0.80; p<0.0001) and improvements in time to distant metastasis (HR, 0.68; 95 percent CI, 0.55-0.83; p=0.0002).¹ Improvements were also seen in MRD as assessed by residual cancer burden rates (30.6 percent vs. 11.7 percent; OR, 3.36; 95 percent CI, 2.67-4.23; nominal p<0.0001), further supporting the depth of response.¹

The safety profile of apalutamide plus hormone therapy was consistent with previous studies. The most common adverse events (AEs) among patients receiving apalutamide included hot flush (63.4 percent), urinary incontinence (50.2 percent) and erectile dysfunction (41.6 percent).^1,2 Grade 3 or 4 AEs occurred in 39.6 percent of patients treated with apalutamide plus hormone therapy, compared to 31.0 percent of those receiving hormone therapy alone.^1,2 Discontinuations due to AEs occurred in 7.4 percent and 2.7 percent of patients, respectively.^1,2 AEs of special interest were generally comparable between treatment arms, with a higher incidence of skin rash observed with apalutamide.^1,2 Rates of deaths were similar between treatment arms.^1,2 In the apalutamide arm, deaths were more often unrelated to prostate cancer, while in the placebo arm, deaths were more frequently associated with disease progression or metastasis.^1,2

Ongoing study of apalutamide in this setting
Apalutamide is currently approved for use in advanced prostate cancer, including cases where the disease has spread (metastatic hormone-sensitive) or is no longer responding to certain hormone therapies (non-metastatic castration-resistant prostate cancer).⁸

Apalutamide plus hormone therapy has not yet been approved by regulatory authorities in this setting. Additional analyses from the PROTEUS study, including ongoing evaluations against current standards of care such as surgery alone, are underway to further contextualise these findings and inform future treatment approaches.