The analyses are from a pivotal phase 3 trial of nadofaragene firadenovec which previously met its primary end point of complete response.
Vikram M. Narayan, MD, highlights findings of subgroup analyses from a pivotal phase 3 trial of the novel intravesical gene-mediated therapy nadofaragene firadenovec in patients with high-grade, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Narayan, of Emory University, Winship Cancer Institute, Atlanta, GA, shared these findings during the 2020 Society of Urologic Oncology (SUO) Annual Meeting.
Previous findings showed the study met its primary end point with nadofaragene firadenovec achieving a complete response (CR) rate of 53.4% at 3 months in a subgroup of patients with carcinoma in situ with or without concomitant high-grade Ta or T1 disease (CIS ± Ta/T1). The 12-month CR rate was 24.3% and the median duration of CR was 9.69 months in these patients.
The data Narayan presented at SUO included the entire study population of 157 patients with high-grade, BCG-unresponsive NMIBC. Subgroups analyses demonstrated that response rates did not show significant differences between age groups, males and females, ≤3 or >3 prior lines of therapy, BCG-refractory versus BCG-relapsed, 0 or ≥1 prior non-BCG regimens, and ≤3 or >3 prior courses of BCG.
For all except 1 subgroup, there were also no significant differences in the subpopulations regarding duration of response. However, in the CIS ± Ta/T1 cohort, the duration of response was significantly longer in patients who had received less than 3 courses of prior BCG (12.68 months) versus those who had received more than 3 courses (4.96 months; P = .0172).