ImmunityBio presented new comparative data at AUA 2026 showing ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus BCG delivers longer-lasting responses and fewer adverse events than FDA-approved therapies in BCG-unresponsive NMIBC.
Written By: Dr. Preethi Putti, PharmD
Reviewed By: Pharmacally Editorial Team
ImmunityBio reported new comparative effectiveness data at the 2026 American Urological Association Annual Meeting showing that ANKTIVA® (nogapendekin alfa inbakicept-pmln; NAI) combined with Bacillus Calmette-Guérin (BCG) delivered longer-lasting responses and favorable safety outcomes in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease.
The analyses compared NAI plus BCG against two FDA-approved therapies: nadofaragene firadenovec-vncg and TAR-200. Both studies used matching-adjusted indirect comparison (MAIC) methods because no head-to-head randomized trials currently exist.
ANKTIVA is a first-in-class IL-15 agonist fusion complex that activates natural killer (NK) cells and CD8+ T cells to strengthen anti-tumor immune activity and sustain immune memory. The therapy targets a major unmet need in BCG-unresponsive NMIBC, where patients often face radical cystectomy after limited bladder-sparing treatment options fail.
In the first analysis, investigators compared individual patient data from the QUILT-3.032 study with aggregate data from the nadofaragene firadenovec trial. After statistical adjustment, NAI plus BCG achieved an anytime complete response rate of 69.7% compared with 53.4% for nadofaragene.
Median duration of complete response reached 22.1 months versus 9.7 months, while cystectomy-free survival improved with a hazard ratio of 0.40. Overall survival did not differ significantly between groups.
A second MAIC analysis compared NAI plus BCG with TAR-200 using data from the SunRISe-1 study. At 12 months, complete response rates numerically favored NAI plus BCG, although the difference was not statistically significant. However, treatment-related adverse events occurred substantially less often with NAI plus BCG, with investigators reporting a 68% reduction in adverse event odds versus TAR-200.
Investigators noted that both analyses carry the limitations inherent to unanchored indirect comparisons, including incomplete alignment of baseline tumor characteristics across trials. Still, sensitivity analyses produced consistent findings across efficacy and safety endpoints.
ImmunityBio said the findings support ANKTIVA plus BCG as a potential immunologic backbone for bladder-preserving treatment strategies while the company continues development efforts tied to recombinant BCG and alternative BCG supply sources amid ongoing U.S. shortages.
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About the Writer
Dr.Preethi Putti, PharmD (LinkedIn) is a pharmaceutical researcher with experience in healthcare and pharmaceutical market research and competitive intelligence. She specializes in analyzing drug pipelines, clinical data, and industry trends and translating complex scientific data into clear and structured medical content. Strong foundation in clinical research, data interpretation, and evidence-based healthcare analysis. Committed to advancing a global career in clinical research and healthcare innovation.