Dr. Barata sobre el Ensayo EMBARK en Pacientes con Cáncer de Próstata no Metastásico de alto Riesgo y Sensible a Hormonas.

Pedro Barata, MD, MSc, director, GU Medical Oncology Research Program, University Hospitals Seidman Cancer Center, associate professor of Medicine, Case Western Reserve University, Case Comprehensive Cancer Center, discusses the importance of the phase 3 EMBARK trial (NCT02319837) in patients with high-risk, nonmetastatic hormone-sensitive prostate cancer (nmHSPC).

Findings from the study, which evaluated enzalutamide (Xtandi) plus leuprolide (Eligard) vs placebo plus leuprolide in patients with nonmetastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR), were presented at the 2023 American Urological Association Annual Meeting. Data showed that enzalutamide plus leuprolide led to a significant reduction in the risk of metastasis or death.

Barata: The idea here is that when patients have a biochemical response, it is important to lower and maintain that response for further treatment. These trials are important because they demonstrate that a combination of intensified treatments can yield better results than what has been previously seen in this disease, which is an important end point. This approach has been proven to be superior. Additionally, it is also important to consider the use of enzalutamide as a monotherapy. It has shown improved outcomes in this population in terms of overall survival, which is completely new compared [with] what was thought to be the standard. Therefore, it is very important to further research this area.

We have a treatment with enzalutamide that works in conjunction with other treatments. However, it is not perfect because it has not been used in the pre-chemotherapy setting.

Based on the patient population enrolled onto the study, we won't be able to see these patients derive benefit. That is a major limitation of this study and why it is important.

However, second-generation hormonal treatments, such as enzalutamide and abiraterone acetate [Zytiga], have shown in other studies that using a hormonal treatment earlier in the disease makes a big difference for patients. Overall, this is a very important study, and I believe the next step is further investigation in clinical trials, which will investigate something like a [combination].