Experimental Drug Receives Fast Track Designation as Second-Line Chemotherapy for Metastatic Castration-Resistant Prostate Cancer
OncoGenex Pharmaceuticals, Inc, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of custirsen (OGX-011) when administered in combination with cabazitaxel (Jevtana Kit)/prednisone for the treatment of men with metastatic castration-resistant prostate cancer following prior treatment with a docetaxel-containing regimen.
Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation, and radiation therapy, and has found to be overexpressed in a number of cancers.
Trial Details
The international, randomized, open-label phase III AFFINITY trial is designed to evaluate whether custirsen, when combined with second-line chemotherapy cabazitaxel and prednisone, has the potential to improve survival outcomes for prostate cancer patients compared to second-line chemotherapy alone. The trial will enroll approximately 630 men and is expected to complete enrollment in the second half of 2014.
Custirsen has also received Fast Track designation from the FDA for treatment of patients with metastatic non–small cell lung cancer as part of the phase III ENSPIRIT trial and for men with metastatic castration-resistant prostate cancer as part of the phase III SYNERGY trial. Enrollment in the ENSPIRIT trial is ongoing and top-line survival results from SYNERGY are expected by mid-2014.
Fast track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
