Novel bladder Ca agent shows promise in phase II trial
There may be a new option, besides radical cystectomy, for patients with high-risk nonmuscle-invasive bladder cancer whose disease is unresponsive to Bacillus Calmette-Guérin (BCG) treatment, according to a phase II study presented at the Genitourinary Cancers Symposium in Orlando, FL.
Researchers found that a replication deficient recombinant adenovirus gene transfer vector, rAd-IFNα/Syn3 (Instiladrin), was associated with a 12-month high-grade recurrence-free survival of 35% for patients with Ta/T1 disease, and was well tolerated.
“I think the single most important finding from the study is that 35% of patients [on rAd-IFNα/Syn3] were free of high-grade recurrence at one year,” lead author Stephen A. Boorjian, MD, of Mayo Clinic, Rochester, MN told Urology Times. “It means this agent has the suggestion of impacting the natural history of this disease, following BCG. The dosing schedule is favorable. It’s basically one dose every 3 months. And the safety profile was quite good.”
In the open-label, multicenter U.S. trial, the authors studied 40 patients with high-grade BCG refractory or relapsed non-muscle invasive bladder cancer, who were randomized to receive either intravesical rAd-IFNα/Syn3 at 1x1011 or 3x1011 viral particles/mL, according to the study abstract. Subjects who responded at 3, 6, and 9 months were re-treated at 4, 7, and 10 months. Among those studied, 21 patients had carcinoma in situ, nine had carcinoma in situ and Ta/T1 disease, and 10 had only Ta/T1, or non-muscle invasive, disease.