Final PEACE‑3 results show enzalutamide plus Bayer’s radium‑223 (Xofigo®) significantly improves overall survival vs enzalutamide alone in men with mCRPC and bone metastases, published in Annals of Oncology.
Written By: Pharmacally Medical News Desk
New Phase III PEACE‑3 data (NCT02194842) show that enzalutamide in combination with Bayer’s radium‑223 dichloride (Xofigo®) significantly improved overall survival in men with metastatic castration‑resistant prostate cancer (mCRPC) and bone metastases.
Presented at the ASCO GU 2026 and published in Annals of Oncology, the data revealed a 24% reduction in death risk with the combination versus enzalutamide alone.
“Despite recent advances, many men with mCRPC and bone metastases face poor prognosis and high progression risk,” said lead investigator Enrique Gallardo, MD, from Parc Tauli Hospital Universitari in Sabadell, Spain. “PEACE-3 demonstrates that early enzalutamide plus radium-223 targeting both cancer cells and bone metastases can extend life while prioritizing bone health to preserve function and independence.”
Key Trial Results
In the final OS analysis of this international, open-label Phase III trial, 446 asymptomatic or mildly symptomatic patients with mCRPC and ≥2 bone metastases were randomized 1:1 to enzalutamide (160 mg daily) alone or plus six cycles of radium-223 (55 kBq/kg IV every 4 weeks).
- OS: Median 38.2 months with combination vs. 32.6 months alone (HR 0.76; 95% CI 0.60-0.96; p=0.0096).
- rPFS (primary endpoint, prior analysis): 19.4 vs. 16.4 months (HR 0.69; 95% CI 0.54-0.87; p=0.0009).
- Benefits held across most subgroups; secondary endpoints included time to next therapy, pain progression, and skeletal events.
This builds on radium-223’s established role in mCRPC with symptomatic bone metastases and no visceral disease, now approved as Xofigo® in over 50 countries.
Broader Impact and Collaborations
“PEACE-3 exemplifies academic cooperative research advancing complex diseases like metastatic prostate cancer,” noted EORTC CEO Denis Lacombe. The trial united EORTC, Clinical Trials Ireland, CUOG, LACOG, and GETUG.
Bayer’s Christine Roth, EVP of Global Product Strategy, emphasized: “These data reinforce our prostate cancer leadership, expanding options across disease stages.” Bayer’s portfolio includes Xofigo®, Nubeqa™, and pipeline assets targeting unmet needs.
Context in Prostate Cancer
Prostate cancer ranks as the second most common cancer in men worldwide, with ~1.5 million annual diagnoses and 397,000 deaths; projections hit 2.9 million by 2040. mCRPC—castration-resistant with distant spread, especially bone—carries 2–3-year median survival, driving demand for combinations like this.
These results position enzalutamide + radium-223 as a potential standard for bone-predominant mCRPC, balancing efficacy, bone protection, and quality of life.
References
Bayer’s radium-223 dichloride plus enzalutamide demonstrates significant overall survival benefit in the PEACE-3 trial in patients with metastatic castration-resistant prostate cancer with bone metastases, 26 February 2026, Bayer’s radium-223 dichloride plus enzalutamide demonstrates significant overall survival benefit in the PEACE-3 trial in patients with metastatic castration-resistant prostate cancer with bone metastases
Gillessen, S. et al., Final overall survival results from EORTC 1333/PEACE-3 trial of enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer, Annals of Oncology, Volume 0, Issue 0, https://doi.org/10.1016/j.annonc.2026.02.009
Phase III Radium 223 mCRPC-PEACE III (PEACE III), ClinicalTrials.gov ID NCT02194842, https://clinicaltrials.gov/study/NCT02194842