Final results from the pivotal Phase III PEACE-3 trial by the European Organization for Research and Treatment of Cancer (EORTC) reveal that a combination therapy improves survival in men with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. 

 

The combination -- XOFIGO (radium-223 dichloride) plus enzalutamide -- reduced the risk of death by 24% compared with enzalutamide alone.

 

“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, EORTC. “These Phase III data provide important insights for clinicians and underline the value of international collaboration in generating evidence that supports clinical decision-making.”

 

The PEACE-3 trial, an international, randomized, open-label study, was designed to evaluate the safety and efficacy of XOFIGO plus enzalutamide in men with mCRPC and bone metastases. While the primary endpoint was rPFS, key secondary endpoints included overall survival (OS), time to subsequent systemic treatment, pain progression, and symptomatic skeletal events.

 

At the final OS analysis, men receiving the combination therapy lived a median of 38.2 months, compared to 32.6 months for those on enzalutamide alone. The primary analysis had already shown a significant improvement in rPFS with the combination therapy.

 

“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, Bayer, engaged commercially.

 

“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.”