Bayer’s XOFIGO® (radium-223 dichloride) Plus Enzalutamide Demonstrates Significant Overall Survival Benefit in PEACE-3 Trial in Patients With Metastatic Castration-Resistant Prostate Cancer With Bone Metastases

• 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 <4) with metastatic castration-resistant prostate cancer (mCRPC) and ≥2 bone metastases. A total of 446 patients were randomized 1:1 to receive either XOFIGO 55 kBq/kg as an intravenous injection monthly for six cycles in combination with enzalutamide 160mg orally daily or enzalutamide 160mg orally daily.

The primary endpoint was radiological progression-free survival (rPFS) by investigator assessment. Key secondary endpoints included overall survival (OS), time to subsequent systemic treatment, pain progression, and symptomatic skeletal event.

This trial was a collaboration with several cancer cooperative groups: the European Organization for Research and Treatment of Cancer (EORTC), Clinical Trial Ireland (CTI), the Canadian Urological Oncology Group (CUOG), the Latin American Cooperative Oncology Group (LACOG), and French UNICANCER Urogenital Tumor Study Group (GETUG).

The trial is supported by Astellas and Pfizer who manufacture enzalutamide (Xtandi) in collaboration with Bayer.

About XOFIGO^® (radium-223 dichloride) Injection²

XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Important Safety Information for XOFIGO^® (radium-223 dichloride) Injection

Warnings and Precautions:

• Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the XOFIGO arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with XOFIGO bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the XOFIGO arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of XOFIGO-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with XOFIGO and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with XOFIGO.
  
  Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue XOFIGO in patients who experience life-threatening complications despite supportive care for bone marrow failure
  
  
• Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of XOFIGO. Prior to first administering XOFIGO, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue XOFIGO if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care
  
  
• Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with XOFIGO have not been established. Outside of a clinical trial, concomitant use of XOFIGO in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, XOFIGO should be discontinued
  
  
• Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: XOFIGO is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of XOFIGO in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received XOFIGO in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of XOFIGO and agents other than gonadotropin-releasing hormone analogues have not been established
  
  
• Embryo-Fetal Toxicity: The safety and efficacy of XOFIGO have not been established in females. XOFIGO can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with XOFIGO

Administration and Radiation Protection: XOFIGO should be received, used, and administered only by authorized persons in designated clinical settings. The administration of XOFIGO is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations

Fluid Status: Dehydration occurred in 3% of patients on XOFIGO and 1% of patients on placebo. XOFIGO increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia

Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on XOFIGO

Secondary Malignant Neoplasms: XOFIGO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, XOFIGO may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the XOFIGO arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial

Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the XOFIGO group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with XOFIGO will tolerate subsequent cytotoxic chemotherapy

Adverse Reactions: The most common adverse reactions (≥10%) in the XOFIGO arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of XOFIGO-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the XOFIGO arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%).

Please see the full Prescribing Information for XOFIGO (radium Ra 223 dichloride).

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes seven marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

¹ Gallardo, E. et al. Final Overall Survival Results from the EORTC 1333/PEACE-3 Trial: Enzalutamide With or Without Radium-223 in Metastatic Castration-Resistant Prostate Cancer. Oral abstract #15. Presented at ASCO GU 2026.
² Xofigo^® (radium-223 dichloride) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, December 2019.
³ Gillessen, S., et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of Radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3. European Society of Medical Oncology 2025 (ESMO) LBA1. September 9, 2024
⁴ Tombal. B., et al. Enzalutamide plus Radium-223 in Metastatic Castration-Resistant Prostate Cancer: Results of the EORTC 1333/PEACE-3 trial. Annals of Oncology. May 30, 2025. DOI: 10.1016/j.annonc.2025.05.011
⁵ ClinicalTrials.gov NCT02194842. Phase III Radium 223 mCRPC-PEACE III (PEACE III). https://clinicaltrials.gov/study/NCT02194842. Accessed January 2026.