ASCO GU 2017: Intravesical rAD-IFNa/Syn3 for patients with high-grade, Bacillus Calmette-Guerin (BCG) refractory or relapsed non-muscle invasive bladder cancer: a phase II randomized study - Session Highlights

Orlando, Florida USA ( Stephen Boorjian, Mayo clinic, discussed the results of the above trial. The trial was funded by FDK Therapies and conducted exclusively through the SUO-CTC. Valrubicin has 10% 1 yr disease free survival and there are limited alternatives for BCG refractory patients. IFNa has pleiotropic antitumor effects with prior studies suggesting insufficient durability with lack of sufficient exposure. Thus, the delivery through a recombinant adenovirus (rAD) was explored based off the work by Dr. Colin Dinney at MD Anderson which showed safety, effective gene transfer and promising clinical results using this delivery method.

The present study is an open label parallel arm Phase II trial which included 13 centers and randomized 43 patients with high grade BCG refractory or relapsed non-muscle invasive bladder cancer 1:1 to rAd-IFNa/Syn3 1x1011 vp/mL or 3x1011 vp/mL with primary endpoint being 12 month high grade recurrence free survival. Median age was 71 years old. Male to female ratio was 33:7.

The 12 month high grade recurrence free survival was 35% and there was no difference between dosage arms. There was no difference based on age or gender. Papillary versus CIS had 12month high grade recurrence free survival 50% v 30%, respectively. There was significant levels of IFNa-2b noted with minimal toxicity. This has led to the development of a multi-center, open-label single arm phase III trial.

Presenter: Stephen Boorjian, Mayo Clinic

Contributed by Stephen B. Williams, MD, Assistant Professor, Division of Urology, The University of Texas Medical Branch at Galveston, Galveston, TX and Ashish M. Kamat, MD, Professor, Department of Urology, The University of Texas MD Anderson, Houston, TX

at the 2017 Genitourinary Cancers Symposium - February 16 - 18, 2017 – Orlando, Florida USA