Washington, DC USA (UroToday.com) In today’s SUO-CTC scientific session at the 2015 Society of Urologic Oncology, Dr. Collin Dinney from MD Anderson Cancer Center viewed the state of novel intravesical therapies for non-muscle invasive bladder cancer (NMIBC).
First, Dr. Dinney reviewed the available tools for research of NMIBC such as the TCGA project and the immune check point inhibitors. Then he described the difficulties in performing randomized controlled trials in these patients. Two trials were initiated by the SUO-CTC for NMIBC patients (EMBARC and Valstar maintenance), both looking at new intravesical treatments and both were halted due to poor patients accrual. Therefore, SUO and FDA MET IN 2012 TO DISCUSS REGISTRATION STRATEGY FOR BCG UNRESPONSSIVE nmibc patients. The panel decided on the definition of BCG unresponsive NMIBC, the appropriate mix of population (minimum component of CIS and on a single arm design for further studies. Endpoint that was agreed upon was recurrence free survival at 12 months. Following these agreements the SUO-CTC collaborated with FKD to execute a phase 2 trial of As-INF-alfa/Syn3 (adenoviral INF gene therapy with syn3 detergent that provides optimal viral transport) for BCG UNRESPONSSIVE NMIBC patients. This treatment was shown to induce regression of human bladder cancer growing in mice. This study randomized 40 patients at 14 centers to 2 doses of the virus (1,3 vp/mL) every 3 months. The endpoint was 25% RFS at 12 months. The trial showed that the majority of recurrences occur by 3 and 6 months and the survival curve plateaus after that. There was no difference in RFS at 12 months between the 2 doses however the median RFS was better with the high dose (3.5 mo VS 11.7 mo). Even patients with CIS had a 30% RFS at 12 mo.
Finally Dr. Dinney described future goals of the SUO-CTC such as explore combination therapy with immune checkpoint inhibitors, lentivirus vectors and inclusion of LG NMIBC in these trials.
Presented by:
Dr. Colin P. Dinney
MD Anderson Cancer Center
Reported by:
Miki Haifler, MD. from the 2015 Winter Meeting of the Society of Urologic Oncology (SUO)"Defining Excellence in Urologic Oncology" - December 2 - 4 Washington, DC USA
Fox Chase Cancer Center