The National Comprehensive Cancer Network (NCCN), a patient care, research and education alliance with 26 world leading cancer institutions, has granted five grants through its Oncology Research Program (ORP) to research proposals focusing on the pre-clinical and clinical effectiveness of enzalutamide for the treatment mantle cell lymphoma, as well as endometrial, hepatocellular, and prostate cancers.
Enzalutamide is a type of hormone therapy consisting of an orally available small molecule drug that targets the androgen receptor and has been shown to reduce prostate cell cancer proliferation and decrease serum prostate specific antigen (PSA) levels in those patients. The drug was approved in 2012 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic castration resistant prostate cancer and is marketed in the U.S under the brand name Xtandi sold as capsules made by Medivation, Inc., and Astellas Pharma US, Inc.
Enzalutamide is currently being studied for the treatment of other types of cancer, including a currently recruiting trial (NCT02489123) to test the drug for the treatment of patients with relapsed or refractory mantle cell lymphoma, a rare B-cell Non-Hodgkin lymphoma.
NCCN’s ORP issued a request for proposals to its 26 members and submissions were peer-reviewed by the NCCN Enzalutamide Scientific Review Committee, based on criteria such as scientific merit and the scope of the studies needed to further evaluate the drug. The grants, funded by Medivation, Inc., and Astellas Pharma US, Inc., were granted to the following investigators and research projects:
- Albert Chang, MD, PhD, UCSF Helen Diller Family Comprehensive Cancer Center, “Phase II Trial of Dose Escalated Radiotherapy with Leuprolide and Enzalutamide in Patients with Very High Risk or Pelvic Node Positive Prostate Cancer;”
- Ajay Gopal, MD, Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, “Androgen Receptor Targeting in Mantle Cell Lymphoma: A Pilot Phase II Trial of Enzalutamide;”
- James Harding, MD, Memorial Sloan Kettering Cancer Center, “A Multi-Center Phase I/II Study of Enzalutamide with and without Sorafenib in Advanced Hepatocellular Carcinoma Patients;”
- Gustavo Leone, PhD, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, “Evaluating the Efficacy of Enzalutamide Therapy in Preventing Tumor Progression in a Preclinical Mouse Model of Type 1 Endometrial Carcinoma;”
- Shannon Westin, MD, MPH, The University of Texas MD Anderson Cancer Center, “A Phase II Study with a Limited Safety Lead-In of Enzalutamide in Combination with Carboplatin and Paclitaxel in Advanced Stage or Recurrent Endometrial Cancer.”
Dr. Robert C. Young, MD, Interim Vice President, NCCN ORP, commented in a press release, “These five studies selected through peer review represent an excellent mix of both clinical and pre-clinical projects, which will further elucidate the activity and utility of this important therapeutic agent.”