The Chemoablative Effect of VesiGel® Instillation in Patients with NMIBC – Preliminary Results

SUO poster presentation, Thursday, Dec 1, 2016

Andrew T. Lenis1, Karim Chamie1, Boris Friedman2, Andrea Tubaro3, Ami Sidi4, Daniel Kedar5, Lorenzo Colombo6, Dov Engelstein7, Joan Palau8, Gregory Wirth9, Ilan Leibovitch10, Eddy Fridman11, Ifat Klein12, Michal Jeshurun12, Fred Witjes13

1Department of Urology, University of California Los Angeles, USA; 2Department of Urology, Carmel Medical Center, Haifa, Israel; 3Department of Urology, S. Andrea Hospital of Rome, Roma, Italy; 4Department of Urology Surgery, The Edith Wolfson Medical Center, Holon, Israel; 5Department of Urology, Rabin MC, Beilinson Hospital, Petah Tikva, Israel; 6Department of Urology, Vita Salute University, San Raffaele Hospital of Milan, Italy; 7Department of Urology, Western Galilee Hospital, Nahariya, Israel; 8Department of Urology, Fundaciò Puigvert of Barcelona, Spain; 9Department of Urology, Hopital HUG of Geneva, Genève, Swiss; 10Department of Urology, Meir Medical Center, Kfar Saba, Israel; 11Institute of Pathology, Sheba Medical Center Hospital- Tel Hashomer, Ramat Gan, Israel; 12UroGen Pharma Ra’anana, Israel; 13Department of Urology, Radboud University of Nijmegen Medical Center, The Netherlands

The standard of care for treatment of patients with low-grade (LG) non-muscle-invasive bladder cancer (NMIBC) is transurethral resection of bladder tumor (TURBT) followed by immediate intravesical chemotherapy. However, more than 50% of patients will recur and require subsequent endoscopic treatments. Endoscopic resection is limited by incomplete imaging of all lesions, deep resections that preclude immediate intravesical therapy, and significant pain that hastens drainage of the intravesical agent. VesiGel, a novel sustained release thermosensitive hydrogel formulation of Mitomycin C (MMC), was developed to overcome these limitations. This study evaluated the primary chemoablative properties of VesiGel in the treatment of patients with LG NMIBC as an alternative to TURBT.

64 patients with LG NMIBC who were all eligible for TURBT were enrolled in the study after informed consent was obtained. The study consisted of 3 groups: Group A- VesiGel 0.06% (40mg at 64mL gel; n=20); Group B- VesiGel 0.12% (80mg at 64mL gel; n=21), and Group C- MMC 0.1% (40mg in 40mL water; n=23). All patients underwent 6 weekly instillations. Response was evaluated 2–4 weeks after the last instillation via cystoscopy and biopsy. Patients who demonstrated complete response (CR) were followed for 12 months without any additional treatment.

The observed adverse events associated with treatments were higher in the VesiGel groups but appeared to be MMC-related. Most events were transient and resolved despite continued therapy. CR rate was 45.0%, 90.5% and 69.6% in groups A, B and C, respectively. For patients with smaller tumors (size ≤1cm2), the CR rate was 50.0%, 93.3% and 77.8%, respectively. For larger tumors (>1cm2), the CR was 40%, 83.3% and 40.0%, respectively. For patients with ≤3 tumors, the CR rate was 50.0%, 86.7% and 80.0%, while for patients with >3 tumors, the CR rate was 0%, 100% and 50%, respectively.

These preliminary results provide an initial indication of the ablative effect of VesiGel and its potential use as an alternative to TURBT. Compared with aqueous MMC 0.1%, VesiGel 0.12% was superior in the treatment of larger and multifocal tumors.

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