New Phase II data suggest Bayer’s NUBEQA (darolutamide), when combined with androgen deprivation therapy (ADT), delivers a substantial survival and disease-control benefit in patients with metastatic castration-sensitive prostate cancer (mCSPC).

 

In the ARASEC trial, NUBEQA plus ADT reduced the risk of progression or death by 71% compared with a matched historical ADT-only cohort from the CHAARTED study in 320 U.S. patients. The regimen also showed significant gains across multiple endpoints, including overall survival, time to metastatic castration-resistant disease, and radiological progression-free survival.

 

Overall survival improved by 50%, while time to metastatic castration-resistant prostate cancer was delayed by 74%. Radiological progression-free survival improved by 70%.

 

Despite the strong results, investigators cautioned that the study has limitations, including its open-label Phase II design, lack of randomization, and reliance on a historical external control arm.

 

“Results from the Phase II ARASEC trial provide additional evidence regarding the efficacy and safety of darolutamide plus ADT in patients with mCSPC,” said Rana R. McKay, Medical Oncologist and Professor of Medicine, Urology, and Radiation Medicine and Applied Sciences and Principal Investigator of the ARASEC trial. 

 

“The data further support NUBEQA’s ability to offer physicians and patients with prostate cancer a treatment option that is both effective and generally well tolerated.”

 

Bayer emphasized that the findings reinforce its broader clinical program. “The ARASEC trial was designed to further evaluate NUBEQA plus ADT in patients with metastatic castration-sensitive prostate cancer using a rigorous and innovative study approach,” said Yesmean Wahdan, Senior Vice President and Head of Medical Affairs, U.S. and North America Pharmaceuticals at Bayer. 

 

“Supported by our robust clinical development program, these results add to the growing body of evidence demonstrating the efficacy and tolerability of NUBEQA and reinforce our commitment to expanding treatment options for patients earlier in the disease.”

 

Safety findings showed no new signals. In the NUBEQA plus ADT group, 58% of treatment-emergent adverse events were grade 1 or 2, and 8% of patients discontinued treatment due to adverse events. Safety data for the control arm were not collected in the historical comparison.

 

ARASEC is a U.S. multicenter Phase II study designed to complement the ongoing Phase III ARANOTE trial and uses a propensity-matched comparison against the CHAARTED ADT-only cohort.