ImmunityBio to Present New Comparative Data, Scientific Advances in Non-Muscle Invasive Bladder Cancer CIS and an Update on BCG Naïve Registrational Trial at American Urological Association Annual Meeting

On May 5, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported it will present new treatment comparison results evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus nadofaragene firadenovec-vncg and TAR-200 in patients with non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease, at the American Urological Association Annual Meeting (AUA 2026) in Washington, DC, May 15-18. An additional oral presentation will include new insights into research of intravesical recombinant BCG (rBCG) in BCG-naïve patients.

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These analyses are clinically relevant for urologists managing an increasingly complex NMIBC treatment landscape, particularly among patients with BCG-unresponsive disease. In the context of limited direct comparative data, cross-trial analyses may provide important context to inform treatment selection and sequencing. By evaluating ANKTIVA + BCG relative to other available options, these data may help characterize comparative efficacy and durability of response within current treatment paradigms.

Dr. Soon-Shiong will be presenting on "The Role of IL15 in the Urological Setting" where he will discuss the mechanisms driving T cell and NK cell activation, examine current clinical evidence, and outline emerging combination approaches in bladder and prostate cancer.

"At AUA 2026, we are advancing the conversation around bladder cancer treatment with new comparative analyses that help contextualize the clinical value of ANKTIVA plus BCG in BCG-unresponsive NMIBC CIS with or without papillary disease," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "These findings, along with emerging insights into recombinant BCG, reflect our commitment to expanding treatment options and addressing critical challenges such as BCG supply constraints. We also continue to prioritize research advancing next-generation immunotherapies for patients with urological cancers, including bladder and prostate cancers, and look forward to sharing this research at the upcoming AUA Annual Meeting."

Oral Presentations

The phase 1/2 ResQ133A-NMIBC trial: A study of intravesical recombinant Mycobacterium Bacillus Calmette Guérin (rBCG) in BCG naïve participants with non-muscle invasive bladder cancer
Meeks J. Oral Podium Presentation: Clinical Trials in Progress: Bladder Cancer, Sunday, May 17, 9:16 am – 9:24 am EDT, The Square, Learning Lab, Hall B, Walter E. Washington Convention Center
Indirect Treatment Comparison of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and Nadofaragene Firadenovec-vncg in patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC)
Edwards B. Oral Podium Presentation PD25-15. Session PD25: Bladder Cancer: Non-invasive V, Monday, May 18, 8:52 am – 9:00 am EDT, Room 206, Walter E. Washington Convention Center
Poster Presentation

An Indirect Treatment Comparison (ITC) of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and TAR-200 in patients with BCG-unresponsive, Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC)
Flanders S. Poster IP50-12. Session IP50: Bladder Cancer: Non-invasive IV, Sunday, May 17, 7:00 am – 9:00 am EDT, Room 146A, Walter E. Washington Convention Center
ImmunityBio Product Theater Presentation

Dr. Soon-Shiong will provide an update on the company’s efforts to expand BCG access and advance research in the BCG naïve setting, and will discuss the role of IL-15 in urological oncology, including mechanisms driving T cell and natural killer (NK) cell activation, current clinical evidence, and emerging combination approaches in bladder and prostate cancer.

The Role of IL15 in the Urological Setting
Dr. Patrick Soon-Shiong, ImmunityBio Product Theater, Saturday, May 16, 1:30 pm EDT, Product Theater booth 2701, Walter E. Washington Convention Center
About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor superagonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the dendritic cell membrane-bound IL-15 receptor alpha driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, MAY 5, 2026, View Source [SID1234665118])