• 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.

Final results from the pivotal 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), delivered a statistically significant overall survival (OS) benefit for patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. The combination reduced the risk of death by 24% compared to enzalutamide alone (hazard ratio [HR] 0.76; 95% CI 0.60–0.96; p=0.0096).

The data were presented during an oral session at the 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium and published simultaneously in Annals of Oncology. Updated radiological progression-free survival (rPFS) results, the trial’s primary endpoint, were also shared.

XOFIGO is currently indicated for patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. The investigational combination with enzalutamide is not yet approved.

According to Enrique Gallardo, MD, of Parc Taulí Hospital Universitari and first author of the PEACE-3 trial, men with mCRPC and bone metastases continue to face poor prognoses despite advances in prostate cancer care. The trial findings suggest that initiating therapy with radium-223 plus enzalutamide may help optimize treatment strategies that prioritize bone health while extending survival.

Health Technology Insights:  https://healthtechnologyinsights.com/how-healthtech-is-rethinking-early-detection-with-smart-screening/ 

The international, randomized, open-label Phase III PEACE-3 trial evaluated 446 patients with asymptomatic or mildly symptomatic mCRPC and at least two bone metastases. Participants were randomized 1:1 to receive either XOFIGO 55 kBq/kg intravenously for six cycles combined with enzalutamide 160 mg daily, or enzalutamide alone.

At final OS analysis, median overall survival reached 38.2 months in the combination arm compared to 32.6 months in the enzalutamide-only group. These findings build upon earlier results showing improved rPFS of 19.4 months versus 16.4 months (HR 0.69; p=0.0009).

Denis Lacombe, CEO of the European Organization for Research and Treatment of Cancer (EORTC), emphasized the importance of collaborative academic research in advancing care for complex diseases such as metastatic prostate cancer. He noted that these Phase III findings provide valuable insights to guide clinical decision-making.

From a safety perspective, Grade 3 or higher treatment-emergent adverse events occurred in 69% of patients receiving the combination versus 58% receiving enzalutamide alone. No individual severe adverse event increased by more than 5% in the combination arm compared to control.

As oncology continues to evolve through precision medicine, data-driven clinical trials, and innovative combination therapies, the PEACE-3 results highlight the potential of targeted radiopharmaceuticals in addressing unmet medical needs in advanced prostate cancer care.

Health Technology Insights: https://healthtechnologyinsights.com/russias-cancer-vaccine-is-a-new-breakthrough-in-health-technology/ 

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