NAI+BCG versus Nadofaragene Results:

  • NAI+BCG treated patients were twice as likely to achieve a complete response (CR) at any point of the study versus nadofaragene firadenovec-vncg in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary disease
  • Median duration of CR with NAI+BCG was more than twice that observed with nadofaragene firadenovec-vncg (22.1 versus 9.7 months)
  • NAI+BCG reduced cystectomy risk by 60% versus nadofaragene

NAI+BCG versus TAR-200 Results:

  • NAI+BCG demonstrated numerically higher 12-month CR rates and fewer treatment-related adverse events of any grade than TAR-200 (61.7% versus 83.5%)

ImmunityBio, Inc. ((IBRX), a vertically integrated commercial-stage immunotherapy company, today announced results from two indirect treatment comparison (ITC) analyses presented at the 2026 American Urological Association (AUA) Annual Meeting evaluating nogapendekin alfa inbakicept-pmln (NAI, ANKTIVA®) plus Bacillus Calmette–Guérin (BCG) against two other U.S. Food and Drug Administration (FDA) approved therapies for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease.

The AUA 2026 ITC presentations were:

  • Podium presentation - PD25-15 (Edwards et al.): NAI+BCG versus nadofaragene firadenovec-vncg in BCG-unresponsive NMIBC CIS with or without papillary disease
  • Interactive poster - IP50-12 (Jayram et al.): NAI+BCG versus TAR-200 in BCG-unresponsive NMIBC CIS with or without papillary disease

Comparative Effectiveness Versus Nadofaragene Firadenovec-vncg

In the absence of head-to-head randomized trials, ImmunityBio conducted a matching-adjusted indirect comparison (MAIC) using individual patient data from QUILT-3.032 (Cohort A, NAI+BCG, n=100) weighted against aggregate data from NCT02773849 (CIS Cohort, nadofaragene firadenovec-vncg, n=103). Baseline matching variables included age (≥65 years), sex, Eastern Cooperative Oncology Group (ECOG) performance status, race, and tumor stage. Effective sample sizes after weighting ranged from 71.7% to 84.2% across endpoints.

After matching, NAI+BCG demonstrated:

  • Anytime CR rate of 69.7% (weighted) versus 53.4% for nadofaragene firadenovec-vncg; OR 2.01 (95% CI: 1.08, 3.72); E-value 3.43
  • Median duration of complete response of 22.1 months versus 9.7 months, a difference of 12.45 months (95% CI: 8.17, 17.09); HR for end of response 0.57 (95% CI: 0.34, 0.95)
  • Cystectomy-free survival HR 0.40 (95% CI: 0.21, 0.75)
  • Overall survival HR 0.85 (95% CI: 0.22, 3.31), not statistically different between treatments

Kaplan-Meier curves for duration of response and cystectomy-free survival remained consistently above the nadofaragene firadenovec-vncg comparator throughout the follow-up period. Sensitivity analyses using simulated treatment comparison (STC) methodology produced consistent results.