ImmunityBio’s Anktiva plus BCG demonstrates superior response durability and favourable safety profile versus approved therapies in BCG-unresponsive bladder cancer at AUA 2026

ImmunityBio 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. 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.

“The magnitude and durability of complete response observed with NAI+BCG, combined with a meaningful reduction in the risk of cystectomy, are clinically relevant for patients with BCG-unresponsive NMIBC for whom bladder preservation is the priority. These comparative data, while subject to the inherent limitations of unanchored indirect comparisons, provide context that can support shared decision making with patients considering bladder-sparing therapy.” – Dr. Brooke B. Edwards, the Urology Group, Cincinnati, OH.

Comparative Effectiveness Versus TAR-200

A separate MAIC was conducted comparing individual patient data from QUILT-3.032 (Cohort A, NAI+BCG, n=100) with aggregate data from SunRISe-1 (Cohort 2, TAR-200, n=85). Matching variables included age, sex, ECOG performance status, race, prior BCG instillations, and tumor stage. Outcomes of interest were complete response rate at 12 months and treatment-related adverse events of any grade.

Key findings from the base-case adjusted MAIC:

• At 12 months, NAI+BCG achieved a higher complete response rate than TAR-200 (49.2% versus 45.9%; OR 1.14; 95% CI: 0.61, 2.15); the difference did not reach statistical significance
• Patients treated with NAI+BCG experienced substantially fewer treatment-related adverse events of any grade than patients treated with TAR-200 (61.7% versus 83.5%), a statistically significant 68% reduction in adverse event odds (OR 0.32; 95% CI: 0.15, 0.67); E-value 5.70
• Sensitivity analyses using both MAIC and STC methodologies produced consistent safety findings, with E-values exceeding 5 across analyses, indicating that any unmeasured confounder capable of negating the safety finding would need to be approximately 5 times stronger than the measured baseline risk factors

“The comparative effectiveness data presented at AUA 2026 reinforce what we have observed across the ANKTIVA development program: that IL-15, working through the trifecta of NK cells, CD8+ T cells, and memory T cells, can produce complete responses that are not only more frequent but materially more durable than other approved therapies for BCG-unresponsive non-muscle invasive bladder cancer. A duration of complete response more than twice as long as with nadofaragene speaks directly to the central question patients ask: ‘how long will my response last?’ These ITC analyses, while subject to the limitations of unanchored comparisons, add to the growing body of evidence that ANKTIVA plus BCG can serve as the immunological backbone of bladder cancer treatments. Beyond the data, the enthusiasm we heard directly from urologists at AUA about our continued advancement of recombinant BCG, and our parallel progress in developing an additional source of conventional BCG with the Tokyo strain, was a welcome confirmation that the field shares our urgency. It is exciting to be in a position to offer urologists and their patients additional sources of intravesical immunotherapy at a moment when the persistent U.S. TICE BCG shortage has made access the binding constraint on care in the urology setting.” –  Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio.