• Final results for the key secondary endpoint of overall survival (OS) from the PEACE-3 trial will be presented by the European Organization for Research and Treatment of Cancer (EORTC) coalition as an oral abstract at ASCO GU 2026.
• XOFIGO® (radium-223 dichloride) in combination with enzalutamide reduced the risk of death by 24% (HR 0.76; 95% CI 0.60-0.96; p=0.0096) and a median OS of 38.2 months (95% CI 33.1-44.8) versus enzalutamide alone (32.6 months, 95% CI 29.3-38.2) in men with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases.

WHIPPANY, N.J.--(BUSINESS WIRE)-- Final results from the pivotal investigational Phase III PEACE-3 trial demonstrate that first-line treatment with XOFIGO® (radium-223 dichloride) in combination with enzalutamide, an androgen receptor pathway inhibitor (ARPI), resulted in a significant overall survival (OS) benefit, reducing the risk of death by 24% versus enzalutamide alone (hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.60-0.96; p=0.0096) in men with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases.1 These data will be presented by the European Organization for Research and Treatment of Cancer (EORTC) coalition in an oral session at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2026 (Oral abstract #15; February 26, 2026. 8:15 – 8:25 AM PST) and published simultaneously in Annals of Oncology. Updated results for radiological progression-free survival (rPFS), the primary endpoint of the trial, will also be shared.

XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.2 XOFIGO is not approved in this investigational indication in combination with enzalutamide.

“Despite recent advances in prostate cancer care, many men with mCRPC and bone metastases continue to face a poor prognosis and a high risk of disease progression,” said Enrique Gallardo, MD, Parc Tauli Hospital Universitari, Sabadell, Spain and First Author and Presenter of the EORTC 1333/PEACE-3 trial. “Results from PEACE-3 show that starting with a combination of radium-223 and enzalutamide, may help support treatment strategies that prioritize bone health.”

The PEACE-3 trial is an international, randomized, open-label, Phase III trial designed to investigate the efficacy and safety of XOFIGO in combination with enzalutamide in patients with mCRPC and bone metastases. The primary endpoint was rPFS by investigator assessment, with key secondary endpoints including OS, time to subsequent systemic treatment, pain progression, and symptomatic skeletal events.

At the time of the final OS analysis, men receiving XOFIGO plus enzalutamide demonstrated a statistically significant improvement in the key secondary endpoint of OS compared to those receiving enzalutamide alone, with a 24% reduction in risk of death (HR 0.76; 95% CI 0.60-0.96; p=0.0096). Median OS was 38.2 months with XOFIGO plus enzalutamide versus 32.6 months with enzalutamide alone.

The final OS results build on the primary analysis, published in Annals of Oncology, which showed a significant improvement in the primary endpoint of radiological progression-free survival (rPFS) with the combination versus enzalutamide alone (19.4 vs. 16.4 months respectively; HR 0.69; 95% CI 0.54–0.87; p=0.0009).3,4

“PEACE-3 is a strong example of how academic cooperative research can help advance progress for complex diseases such as metastatic prostate cancer,” said Denis Lacombe, Chief Executive Officer, European Organization for Research and Treatment of Cancer (EORTC). EORTC is a non-governmental, non-profit organization, which unites clinical cancer research experts, throughout Europe, to coordinate and conduct international translational and clinical research. “These Phase III data provide important insights for clinicians and underline the value of international collaboration in generating evidence that supports clinical decision-making.”

“These new PEACE-3 data reinforce Bayer’s leadership in prostate cancer care and our long term commitment to addressing the unmet medical needs of patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “By investigating combination approaches, we are building a growing prostate cancer portfolio with the potential to bring new treatment options to patients across different stages of the disease.”

Grade 3 or higher treatment emergent adverse events (TEAE) were recorded in 69% of patients in the combination arm versus 58% of patients treated with enzalutamide alone. No individual TEAE Grade 3 or higher has increased by more than 5% in the combination arm compared to the enzalutamide arm alone.1

About PEACE-3 (EORTC GUCG-1333)5

The PEACE-3 trial is an international, randomized, open-label, Phase III trial designed to investigate the efficacy and safety of XOFIGO in combination with enzalutamide in asymptomatic or mildly symptomatic patients (Brief Pain Inventory score

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