Johnson & Johnson's Phase 3 prostate cancer study shows ERLEADA® (apalutamide) before and after surgery significantly reduces risk of metastasis or death, breaking a decades-long treatment paradigm

Rhea-AI Summary

Johnson & Johnson (NYSE:JNJ) reported final Phase 3 PROTEUS data for investigational perioperative use of ERLEADA (apalutamide) plus hormone therapy in high-risk localized or locally advanced prostate cancer.

The regimen before and after surgery met both primary endpoints, improved multiple disease-control measures, and is not yet approved in this setting.

AI-generated analysis. Not financial advice.

Positive

• pCR/minimal residual disease 8.9% with apalutamide combo vs 1.0% with hormone therapy alone
• 20% reduction in risk of metastasis or death; HR 0.80, 95% CI 0.67–0.96
• Time to subsequent therapy extended to 74.2 vs 41.5 months; HR 0.65
• 29% reduction in risk of disease recurrence or death; event-free survival HR 0.71
• Improved time to distant metastasis; HR 0.68, 95% CI 0.55–0.83
• Most patients recovered adequate testosterone levels within 8.1 months

Negative

• Grade 3/4 adverse events 39.6% with apalutamide combo vs 31.0% with hormone therapy alone
• Treatment discontinuations due to adverse events 7.4% vs 2.7% with hormone therapy alone
• Higher incidence of skin rash reported with apalutamide plus hormone therapy
• Perioperative apalutamide plus hormone therapy is not yet approved in this setting

Key Figures

pCR/MRD rate (combo): 8.9% pCR/MRD rate (control): 1.0% Metastasis/death risk reduction: 20% +5 more

8 metrics

pCR/MRD rate (combo) 8.9% Apalutamide + hormone therapy before/after surgery

pCR/MRD rate (control) 1.0% Hormone therapy alone

Metastasis/death risk reduction 20% Hazard ratio 0.80; 95% CI 0.67–0.96; p=0.02

Study size 2,109 patients Phase 3 PROTEUS high-risk prostate cancer

Median follow-up 61.7 months Assessment of primary endpoints

Time to subsequent therapy (combo) 74.2 months Apalutamide + hormone therapy

Time to subsequent therapy (control) 41.5 months Hormone therapy alone

Event-free survival risk reduction 29% Event-free survival HR 0.71; 95% CI 0.63–0.80

Market Reality Check

Price: $225.33 Vol: Volume 10,859,003 is 41% ...

normal vol

$225.33 Last Close

Volume Volume 10,859,003 is 41% above the 20-day average of 7,710,018, indicating elevated trading activity ahead of this news. normal

Technical Price at 225.33 is trading above the 200-day MA of 211.88, reflecting a pre-existing longer-term uptrend.

Peers on Argus

While JNJ was down 2.37%, key peers showed smaller mixed moves: ABBV -0.57%, AZN...

While JNJ was down 2.37%, key peers showed smaller mixed moves: ABBV -0.57%, AZN -0.27%, LLY -1.95%, NVS -1.10%, NVO +0.22%, pointing to a stock-specific move rather than a broad sector shift.

Previous Clinical trial Reports

5 past events · Latest: May 05 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
May 05	Robotic surgery trial	Positive	+0.6%	Pivotal OTTAVA robotic system study met safety and performance endpoints.
Apr 10	Ophthalmology data	Positive	-1.2%	TECNIS PureSee IOL data showed strong vision outcomes and high satisfaction.
Mar 03	Fast Track lupus drug	Positive	-0.7%	Nipocalimab received FDA Fast Track based on Phase 2 SLE results.
Jan 06	Phase 2 SLE results	Positive	+0.2%	Nipocalimab Phase 2b JASMINE met primary and key secondary endpoints.
Dec 09	Myeloma Phase 3 data	Positive	-0.8%	MajesTEC-3 showed major survival and response benefits; sBLA submitted.

Pattern Detected

Recent clinical trial announcements have generally been positive, but JNJ’s stock often showed muted or negative next-day moves, with more divergences than alignments.

Recent Company History

Over the past six months, JNJ has released multiple late-stage clinical updates across oncology, immunology and surgical technologies. Events include Phase 3 MajesTEC-3 multiple myeloma data on Dec 9, 2025, positive Phase 2b SLE results for nipocalimab on Jan 6, 2026, Fast Track designation for nipocalimab on Mar 3, 2026, ophthalmology data on TECNIS PureSee IOL on Apr 10, 2026, and pivotal OTTAVA™ robotic surgery data on May 5, 2026. Despite broadly favorable outcomes, price reactions were often small or negative, providing context for how investors have treated clinical news.

Historical Comparison

-0.4% avg move · In the last five clinical trial headlines, JNJ’s average next-day move was -0.38%, suggesting genera...

clinical trial

-0.4%

Average Historical Move clinical trial

In the last five clinical trial headlines, JNJ’s average next-day move was -0.38%, suggesting generally modest or cautious market reactions even to positive study results.

Same-tag history shows a broad late-stage pipeline: strong Phase 3 oncology data, positive Phase 2 and Fast Track momentum in SLE, and pivotal device and ophthalmology outcomes, underscoring diversified clinical development.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2026-02-11

An effective S-3ASR shelf filed on 2026-02-11 allows JNJ to issue unsecured debt securities over time under an existing indenture. Terms for each series will be set via prospectus supplements, with net proceeds earmarked for general corporate purposes including working capital, capex, buybacks, refinancing and acquisitions.

Market Pulse Summary

This announcement details robust Phase 3 PROTEUS results, including an 8.9% pCR/MRD rate versus 1.0%...

Analysis

This announcement details robust Phase 3 PROTEUS results, including an 8.9% pCR/MRD rate versus 1.0% on control and a 20% reduction in metastasis or death, highlighting meaningful perioperative benefit in high-risk localized prostate cancer. Prior clinical trial news for JNJ has produced small, mixed price reactions, underscoring that strong data do not always translate into large stock moves. Investors may watch for regulatory decisions, label expansions, competitive therapies and follow-up safety data to gauge long-term impact.

Key Terms

androgen deprivation therapy, pathologic complete response, minimal residual disease, metastasis-free survival, +4 more

8 terms

androgen deprivation therapy medical

"investigational use of apalutamide plus hormone therapy (androgen deprivation therapy, ADT), given for six months"

Androgen deprivation therapy is a medical treatment that lowers or blocks male hormones (androgens) to slow the growth of hormone-sensitive cancers, most commonly prostate cancer. Think of it as cutting off the fuel a fire needs so the blaze slows; for investors, changes in ADT use, new ADT drugs, or clinical trial results can affect demand for medications, device procedures, safety profiles and long-term revenue for healthcare companies.

pathologic complete response medical

"8.9 percent vs. 1.0 percent; pathologic complete response/minimal residual disease"

Pathologic complete response is the finding, after pre-surgery cancer treatment, that no detectable invasive tumor cells remain in the removed tissue and nearby lymph nodes. It matters to investors because it is an objective sign that a therapy worked well before long-term outcomes are known, much like a cleared garden showing a weed-killer worked; strong rates can speed regulatory approval, boost adoption and drive a drug’s commercial prospects.

minimal residual disease medical

"8.9 percent vs. 1.0 percent; pathologic complete response/minimal residual disease"

Minimal residual disease (MRD) is the tiny number of cancer cells that remain in the body after treatment, often too few to show up on standard scans but detectable with very sensitive tests. For investors, MRD is important because it predicts the risk of relapse and can determine whether a therapy is seen as effective, influences regulatory and reimbursement decisions, and affects the size and timing of a drug’s market opportunity—like spotting the last weeds that can make a garden regrow if not removed.

metastasis-free survival medical

"how long patients lived without the cancer spreading (metastasis-free survival, MFS), both assessed"

Metastasis-free survival is the length of time after treatment during which a patient shows no signs that cancer has spread to other parts of the body. For investors, it’s a key clinical measure of a drug’s effectiveness — like how long a repair keeps a leak from returning — because longer metastasis-free survival can improve chances of regulatory approval, support stronger sales forecasts, and reduce future treatment costs.

hazard ratio medical

"risk of metastasis or death (hazard ratio [HR], 0.80; 95 percent confidence interval"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

odds ratio medical

"1.0 percent with hormone therapy alone (odds ratio [OR], 10.17; 95 percent confidence"

The odds ratio compares how likely an outcome is in one group versus another by dividing the odds of the event in the first group by the odds in the second. Think of it like comparing the odds of a coin landing heads in two different scenarios; a number above 1 means the event is more likely in the first group, below 1 means it is less likely. Investors use it to quantify how strongly a treatment, risk factor, or policy changes the chance of an outcome, which helps assess clinical trial results, regulatory risk, and potential impact on a company’s prospects.

event-free survival medical

"a 29 percent reduction in the risk of disease recurrence or death (event-free survival; HR, 0.71;"

Event-free survival measures the length of time after a treatment or diagnosis during which a patient does not experience a predefined negative outcome, such as disease progression, relapse, or death. For investors, longer event-free survival in clinical trials signals that a therapy may be effective and durable, improving its chances of regulatory approval and commercial success — think of it like a warranty period before problems reappear.

androgen receptor pathway inhibitor medical

"PROTEUS is a Phase 3 study evaluating apalutamide, an androgen receptor pathway inhibitor, combined"

A drug that blocks the androgen receptor pathway stops male hormones from turning on signals that make certain cells grow, much like putting a cover over a door lock so a key can’t open it. Investors care because these drugs target diseases driven by those hormone signals (for example some cancers), and their clinical trial results, regulatory approval, and market demand directly affect a company’s future revenue and valuation.

AI-generated analysis. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• Patients were nine times more likely to have little to no cancer remaining in the prostate after surgery, with a 20% reduction in the risk of developing metastasis or death 
• Data selected to open the plenary presentation at ASCO 2026 and published in The New England Journal of Medicine

CHICAGO, May 31, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results from the final analysis of the Phase 3 PROTEUS study showing the investigational use of apalutamide plus hormone therapy (androgen deprivation therapy, ADT), given for six months before and after prostate cancer surgery, significantly improved key short- and long-term clinical outcomes for patients with high-risk localized 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 percent vs. 1.0 percent; pathologic complete response/minimal residual disease). 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. 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.^1,2

The unmet need with standard treatments for patients with high-risk localized prostate cancer

Surgery to remove the prostate (radical prostatectomy) is one of the standard treatments for patients with high-risk localized 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.^5,6,7 Additional therapies are often used only after the cancer has spread, missing a critical window to intervene earlier and improve long-term outcomes.⁸ 

Apalutamide blocks androgen hormones from binding to their receptor, which can help slow prostate cancer progression. It is currently approved for use in advanced prostate cancer, including cases where the disease has spread (metastatic castration-sensitive) or is no longer responding to certain hormone therapies (non-metastatic castration-resistant prostate cancer).⁹

Expert perspectives on the perioperative use of ERLEADA^® plus hormone therapy six months before and after prostate cancer surgery

"Reducing the risk of prostate cancer recurrence and death with improved initial treatment regimens has been a longstanding unmet need for patients with localized high-risk prostate cancer," said Mary-Ellen Taplin,* M.D., FASCO, medical oncologist at Dana-Farber Cancer Institute and Harvard Medical School, and principal investigator. "The PROTEUS trial demonstrates that adding preoperative apalutamide to androgen deprivation therapy and surgery reduced the risk of metastases or death by 20 percent. This result is most impactful as it may reduce the need for subsequent therapies and related side effects, while also increasing potential cure rates. This approach, which combines systemic therapy with surgery, is already standard in other aggressive cancers and now has proven benefit in patients with this disease."

"For decades, surgery has been the standard approach for many patients with high-risk localized or locally advanced prostate cancer, but these data suggest it may not be enough on its own," said Adam Kibel,^† M.D., urologic surgeon and chair of the Department of Urology at Mass General Brigham. "Earlier integration of apalutamide has the potential to reshape how prostate cancer is treated by building on curative-intent surgical treatment and improving outcomes for these patients."

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 localized or locally advanced prostate cancer (n=2109). 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). 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. Similar metastasis-free survival 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. 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). Most patients also recovered adequate testosterone levels within 8.1 months. 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). 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 among patients receiving apalutamide included hot flush (63.4 percent), urinary incontinence (50.2 percent) and erectile dysfunction (41.6 percent). Grade 3 or 4 adverse events occurred in 39.6 percent of patients treated with apalutamide plus hormone therapy, compared to 31.0 percent of those receiving hormone therapy alone. Discontinuations due to adverse events occurred in 7.4 percent and 2.7 percent of patients, respectively. Adverse events of special interest were generally comparable between treatment arms, with a higher incidence of skin rash observed with apalutamide. Rates of deaths were similar between treatment arms. 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

"These findings point to a new potential way of treating patients with high-risk localized or locally advanced prostate cancer," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "Apalutamide has already shown an overall survival benefit in advanced disease. Now we're seeing its impact 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."

Ongoing study of ERLEADA^® in this setting

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 contextualize these findings and inform future treatment approaches.

About the PROTEUS study

PROTEUS (NCT03767244) is a randomized, double-blind, placebo-controlled Phase 3 study evaluating apalutamide in combination with androgen deprivation therapy (ADT) in patients with high-risk localized or locally advanced prostate cancer who are candidates for radical prostatectomy. Approximately 2,000 patients were enrolled and randomized to receive apalutamide or placebo, each in combination with ADT, administered before and after radical prostatectomy with pelvic lymph node dissection. Patients with distant metastatic disease, as determined by conventional imaging, were excluded from the study.¹⁰ 

Apalutamide was administered orally at 240 mg once daily. All study participants underwent protocol-defined surgery and were followed for long-term outcomes, including recurrence and progression. The dual primary endpoints of the study are pathologic complete response (pCR) and metastasis-free survival (MFS), with pCR assessed by blinded independent central pathology review and MFS assessed by blinded independent central radiology review.¹⁰

About High-Risk Localized or Locally Advanced Prostate Cancer

Approximately 330,000 people are diagnosed with prostate cancer each year in the U.S.¹¹ Up to 40 percent of patients will be classified as high-risk.¹² Despite advancements in treatment, disease recurrence remains substantial in patients with high-risk localized or locally advanced prostate cancer; up to 50 percent of patients within five years of surgery experience recurrence and carry a significant risk of disease progression and death.^5,6 It's estimated that more than 36,000 patients will succumb to prostate cancer in 2026, which reinforces the importance of choosing the best possible therapy early for patients with advanced prostate cancer.^8,12

About ERLEADA^®

ERLEADA^® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). ERLEADA^® received U.S. Food and Drug Administration (FDA) approval for nmCRPC in February 2018 and received U.S. FDA approval for mCSPC in September 2019. To date, more than 340,000 patients worldwide have been treated with ERLEADA^®.⁹ Additional studies are ongoing to evaluate ERLEADA^® in earlier stages of prostate cancer, including high-risk localized and locally advanced disease.

The legal manufacturer for ERLEADA^® is Janssen Biotech, Inc. For more information, visit www.ERLEADAHCP.com.

INDICATIONS

ERLEADA^® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with:

• Metastatic castration-sensitive prostate cancer (mCSPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

ERLEADA^® IMPORTANT SAFETY INFORMATION⁹

WARNINGS AND PRECAUTIONS

Cerebrovascular and Ischemic Cardiovascular Events, including events leading to death, occurred in patients receiving ERLEADA. Monitor for signs and symptoms of ischemic heart disease and cerebrovascular disorders. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Consider discontinuation of ERLEADA for Grade 3 and 4 events.

In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 3.7% of patients treated with ERLEADA and 2% of patients treated with placebo. In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4.4% of patients treated with ERLEADA and 1.5% of patients treated with placebo. Across the SPARTAN and TITAN studies, 4 patients (0.3%) treated with ERLEADA and 2 patients (0.2%) treated with placebo died from an ischemic cardiovascular event. Patients with history of unstable angina, myocardial infarction, congestive heart failure, stroke, or transient ischemic attack within 6 months of randomization were excluded from the SPARTAN and TITAN studies.

In the SPARTAN study, cerebrovascular events occurred in 2.5% of patients treated with ERLEADA and 1% of patients treated with placebo. In the TITAN study, cerebrovascular events occurred in 1.9% of patients treated with ERLEADA and 2.1% of patients treated with placebo. Across the SPARTAN and TITAN studies, 3 patients (0.2%) treated with ERLEADA and 2 patients (0.2%) treated with placebo died from a cerebrovascular event.

Fractures occurred in patients receiving ERLEADA. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.

In a randomized study (SPARTAN) of patients with nmCRPC, fractures occurred in 12% of patients treated with ERLEADA and in 7% of patients treated with placebo. In a randomized study (TITAN) of patients with mCSPC, fractures occurred in 9% of patients treated with ERLEADA and in 6% of patients treated with placebo.

Falls occurred in patients receiving ERLEADA with increased frequency in the elderly. Evaluate patients for fall risk.

In a randomized study (SPARTAN), falls occurred in 16% of patients treated with ERLEADA compared with 9% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure.

Seizure occurred in patients receiving ERLEADA. Permanently discontinue ERLEADA in patients who develop a seizure during treatment. It is unknown whether anti-epileptic medications will prevent seizures with ERLEADA. Advise patients of the risk of developing a seizure while receiving ERLEADA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others.

In two randomized studies (SPARTAN and TITAN), five patients (0.4%) treated with ERLEADA and one patient treated with placebo (0.1%) experienced a seizure. Seizure occurred from 159 to 650 days after initiation of ERLEADA. Patients with a history of seizure or, predisposing factors for seizure, or receiving drugs known to decrease the seizure threshold or to induce seizure were excluded. There is no clinical experience in re-administering ERLEADA to patients who experienced a seizure.

Severe Cutaneous Adverse Reactions — Fatal and life-threatening cases of severe cutaneous adverse reactions (SCARs), including Stevens–Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) occurred in patients receiving ERLEADA.

Monitor patients for the development of SCARs. Advise patients of the signs and symptoms of SCARs (eg, a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy). If a SCAR is suspected, interrupt ERLEADA until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, or for other Grade 4 skin reactions, permanently discontinue ERLEADA [see Dosage and Administration (2.2)].

Interstitial Lung Disease (ILD)/Pneumonitis — Fatal and life-threatening interstitial lung disease (ILD) or pneumonitis can occur in patients treated with ERLEADA.

Post-marketing cases of ILD/pneumonitis, including fatal cases, occurred in patients treated with ERLEADA. Across clinical trials (TITAN and SPARTAN, n=1327), 0.8% of patients treated with ERLEADA experienced ILD/pneumonitis, including 0.2% who experienced Grade 3 events [see Adverse Reactions (6.1, 6.2)].

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold ERLEADA if ILD/pneumonitis is suspected.

Permanently discontinue ERLEADA in patients with severe ILD/pneumonitis or if no other potential causes of ILD/pneumonitis are identified [see Dosage and Administration (2.2)].

Embryo-Fetal Toxicity — The safety and efficacy of ERLEADA have not been established in females. Based on findings from animals and its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA [see Use in Specific Populations (8.1, 8.3)].

ADVERSE REACTIONS

The most common adverse reactions (≥10%) that occurred more frequently in the ERLEADA-treated patients (≥2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.

Laboratory Abnormalities — All Grades (Grade 3-4)

• Hematology — In the TITAN study: white blood cell decreased ERLEADA 27% (0.4%), placebo 19% (0.6%). In the SPARTAN study: anemia ERLEADA 70% (0.4%), placebo 64% (0.5%); leukopenia ERLEADA 47% (0.3%), placebo 29% (0%); lymphopenia ERLEADA 41% (1.8%), placebo 21% (1.6%)
• Chemistry — In the TITAN study: hypertriglyceridemia ERLEADA 17% (2.5%), placebo 12% (2.3%). In the SPARTAN study: hypercholesterolemia ERLEADA 76% (0.1%), placebo 46% (0%); hyperglycemia ERLEADA 70% (2%), placebo 59% (1.0%); hypertriglyceridemia ERLEADA 67% (1.6%), placebo 49% (0.8%); hyperkalemia ERLEADA 32% (1.9%), placebo 22% (0.5%)

Rash — In 2 randomized studies (SPARTAN and TITAN), rash was most commonly described as macular or maculopapular. Adverse reactions of rash were 26% with ERLEADA vs 8% with placebo. Grade 3 rashes (defined as covering >30% body surface area [BSA]) were reported with ERLEADA treatment (6%) vs placebo (0.5%).

The onset of rash occurred at a median of 83 days. Rash resolved in 78% of patients within a median of 78 days from onset of rash. Rash was commonly managed with oral antihistamines and topical corticosteroids, and 19% of patients received systemic corticosteroids. Dose reduction or dose interruption occurred in 14% and 28% of patients, respectively. Of the patients who had dose interruption, 59% experienced recurrence of rash upon reintroduction of ERLEADA.

Hypothyroidism — In 2 randomized studies (SPARTAN and TITAN), hypothyroidism was reported for 8% of patients treated with ERLEADA and 1.5% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. Elevated TSH occurred in 25% of patients treated with ERLEADA and 7% of patients treated with placebo. The median onset was at the first scheduled assessment. There were no Grade 3 or 4 adverse reactions. Thyroid replacement therapy, when clinically indicated, should be initiated or dose adjusted.

DRUG INTERACTIONS

Effect of Other Drugs on ERLEADA

ERLEADA Strong CYP2C8 or CYP3A4 Inhibitors

Reduce the ERLEADA dose as recommended for adverse reactions [see Dosage and Administration (2.2)]. Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady–state exposure of the active moieties (sum of unbound apalutamide plus the potency–adjusted unbound N-desmethyl-apalutamide).

Effect of ERLEADA on Other Drugs

Substrates of CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP, or OATP1B1

Refer to the Prescribing Information for these substrates. Consider alternative agents when possible or evaluate for loss of activity of the substrate if concomitant use cannot be avoided.

• Apalutamide is a strong inducer of CYP3A4 and CYP2C19, a weak inducer of CYP2C9, and an inducer of P-gp, BCRP, and OATP1B1. Apalutamide decreases exposure of substrates of CYP3A4, CYP2C19, CYP2C9, P-gp, BCRP, or OATP1B [see Clinical Pharmacology (12.3)], which may decrease the effectiveness of these substrates.

USE IN SPECIFIC POPULATIONS

The recommended ERLEADA dosage in patients with (Child-Pugh C) is lower than the recommended dosage in patients with normal hepatic function. No dosage modification is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.

Please see full Prescribing Information for ERLEADA.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of ERLEADA^® (apalutamide). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Media contacts:  Oncology Media Relations   oncology_media_relations@its.jnj.com

Investor contact: Jess Margevich investor-relations@its.jnj.com U.S. Medical Inquiries +1 800 526-7736

*Dr. Taplin has provided consulting, advisory, and speaking services to Johnson & Johnson; she has not been paid for any media work.

^†Dr. Kibel has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

__________________________________

¹ Taplin, M. et. al. Perioperative (neoadjuvant and adjuvant) apalutamide (APA) + androgen deprivation therapy (ADT) vs placebo (PBO) + ADT with radical prostatectomy (RP) in high-risk localized or locally advanced prostate cancer (HR LPC/LAPC): Final analysis of the PROTEUS phase 3 study. Presented at: 2026 American Society of Clinical Oncology (ASCO); May 31, 2026; Chicago.

² Taplin ME, Gleave M, Shore ND, et al. Perioperative Apalutamide in High-Risk Localized Prostate Cancer. N Engl J Med. 2026. doi:10.1056/NEJMoa2603878.

³ Young HH. The early diagnosis and radical cure of carcinoma of the prostate. Being a study of 40 cases and presentation of a radical operation which was carried out in four cases. 1905. J Urol. 2002;168:914-21. doi:10.1016/s0022-5347(05)64542-9

⁴ Cooley LF, Shore ND. Historic progression of prostatectomy techniques and associated outcomes. Transl Androl Urol. 2025;14:493-495. doi: 10.21037/tau-2025-3

⁵ Eiber M, et al. PHAROS, a real-world multi-country European study on patients with high-risk localised and locally advanced prostate cancer receiving radical treatment. J Clin Oncol. 2024;42:5024. DOI: 10.1200/JCO.2024.42.16_suppl.502

⁶ Stattin P, et al. Population-based study of disease trajectory after radical treatment for high-risk prostate cancer. BJU Int. 2024;134:96-102. doi.org/10.1111/bju.16362

⁷ National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: prostate cancer. Version 5.2026. Accessed May 2026. https://www.nccn.org.

⁸ American Cancer Society. Initial treatment of prostate cancer, by stage and risk group. Accessed May 2026. https://www.cancer.org/cancer/types/prostate-cancer/treating/by-stage.html 

⁹ ERLEADA^® U.S. Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

¹⁰ ClinicalTrials.gov. A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy (PROTEUS). Available at: https://clinicaltrials.gov/ct2/show/NCT04077463. Accessed May 2026.

¹¹ American Cancer Society. Key statistics for prostate cancer. Accessed May 2026. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html 

¹² Napodano G, Ferro M, Sanseverino R. High-risk prostate cancer: A very challenging disease in the field of uro-oncology. Diagnostics (Basel). 202126;11(3):400. doi:10.3390/diagnostics11030400

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/johnson--johnsons-phase-3-prostate-cancer-study-shows-erleada-apalutamide-before-and-after-surgery-significantly-reduces-risk-of-metastasis-or-death-breaking-a-decades-long-treatment-paradigm-302786429.html

SOURCE Johnson & Johnson

FAQ

What did Johnson & Johnson (JNJ) announce about the Phase 3 PROTEUS trial for ERLEADA in prostate cancer?

Johnson & Johnson announced that the Phase 3 PROTEUS trial met both primary endpoints in high-risk localized or locally advanced prostate cancer. According to Johnson & Johnson, perioperative ERLEADA plus hormone therapy improved pathologic response and metastasis-free survival versus hormone therapy alone.

How much did ERLEADA (apalutamide) reduce metastasis or death risk in the PROTEUS Phase 3 study for JNJ?

ERLEADA plus hormone therapy reduced the risk of metastasis or death by 20% compared with hormone therapy alone. According to Johnson & Johnson, the hazard ratio was 0.80 with a 95% confidence interval of 0.67–0.96 and p=0.02.

What were the key efficacy outcomes of Johnson & Johnson's PROTEUS trial for ERLEADA (JNJ) around prostate surgery?

The regimen increased pCR/minimal residual disease to 8.9% vs 1.0% and delayed progression events. According to Johnson & Johnson, it also extended time to subsequent therapy to 74.2 vs 41.5 months and improved event-free and distant metastasis-free survival.

What side effects were observed with ERLEADA plus hormone therapy in Johnson & Johnson's PROTEUS Phase 3 study?

Common side effects included hot flush, urinary incontinence, and erectile dysfunction, with more grade 3/4 events. According to Johnson & Johnson, discontinuations due to adverse events were 7.4% with the combination versus 2.7% with hormone therapy alone, and rash was more frequent.

Is ERLEADA approved for perioperative use in high-risk localized prostate cancer after the PROTEUS results for JNJ?

ERLEADA plus hormone therapy is not yet approved for this perioperative high-risk localized prostate cancer setting. According to Johnson & Johnson, additional analyses versus standards such as surgery alone are ongoing to contextualize PROTEUS results and inform future treatment approaches.

How long were patients followed in Johnson & Johnson's PROTEUS Phase 3 trial of ERLEADA (JNJ)?

Patients in the PROTEUS study had a median follow-up of 61.7 months at final analysis. According to Johnson & Johnson, outcomes such as metastasis-free survival, event-free survival, and time to subsequent therapy were assessed over this multi-year period.