Overall, custirsen was well-tolerated in combination with either docetaxel or mitoxantrone administered as second-line chemotherapy in patients with hormone refractory prostate cancer. Custirsen was associated with durable pain responses in 50% or more of patients, a minimum of a 50% PSA decline in 27% or more of patients, and better than expected survival with 60% of patients alive at a median follow-up of 13.3 months.
This study was designed as an open-label, randomized, multicenter study evaluating weekly administration of custirsen in combination with second-line chemotherapy in patients with metastatic hormone refractory prostate cancer who were previously treated with a minimum of two cycles of docetaxel-based first-line chemotherapy. Patients in this study represented a poor prognostic population due to rapid disease progression after completing first-line docetaxel therapy.
Clinical studies that will support product approval are being planned utilizing chemotherapy plus custirsen as second-line therapy in patients progressing after a first-line docetaxel regimen.