CULVER CITY, Calif. – May 5, 2026
ImmunityBio Inc. has announced it will present new comparative clinical data and scientific advances in non-muscle invasive bladder cancer (NMIBC) at the American Urological Association Annual Meeting 2026, highlighting the performance of ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus BCG versus competing therapies including nadofaragene firadenovec-vncg and TAR-200. The presentations will focus on efficacy, durability of response, and safety outcomes in patients with carcinoma in situ (CIS) with or without papillary disease, providing critical cross-trial insights in the absence of direct head-to-head studies. The company will also share updates on its ongoing registrational trial in BCG-naïve patients, signaling continued progress in expanding treatment options and addressing supply limitations in bladder cancer care.
Comparative Clinical Insights in NMIBC Treatment
The upcoming data presentations will include cross-trial analyses comparing ANKTIVA plus BCG against other approved and investigational therapies, offering valuable clinical context for physicians navigating an increasingly complex treatment landscape. In patients with BCG-unresponsive NMIBC, where treatment options are limited and outcomes are often suboptimal, these analyses aim to clarify relative treatment performance, particularly in terms of response durability and long-term disease control. While not a substitute for direct randomized comparisons, such analyses are practically important for real-world decision-making, helping clinicians optimize treatment sequencing and personalize therapy selection based on available evidence. The data reinforces the growing role of immunotherapy combinations in improving outcomes in high-risk bladder cancer patients.
Advancing Innovation in BCG-Naïve Patient Population
In addition to comparative data, ImmunityBio Inc. will present new findings from its Phase 1/2 ResQ133A-NMIBC trial, which explores the use of intravesical recombinant BCG (rBCG) in BCG-naïve patients. This represents a strategic effort to expand treatment into earlier lines of care, rather than focusing only on resistant disease. The study aims to evaluate how next-generation BCG formulations can enhance immune activation and improve treatment outcomes, particularly in patients receiving first-line therapy.
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This approach also addresses a major industry challenge, which is the global shortage and inconsistent availability of traditional BCG, by exploring alternative and scalable immunotherapy solutions. The company is also advancing a randomized controlled registrational trial in BCG-naïve patients, which could play a pivotal role in future regulatory approvals and treatment guidelines.
IL-15 Mechanism and Next-Generation Immunotherapy Strategy
A key highlight of the AUA 2026 presentations will be a session led by Patrick Soon-Shiong, focusing on the role of interleukin-15 (IL-15) in urological cancers, including its ability to activate natural killer (NK) cells and CD8+ T cells, which are essential for targeting and eliminating cancer cells. ANKTIVA, a first-in-class IL-15 receptor superagonist, is designed to restore immune system function, overcome tumor resistance, and generate long-lasting immune memory, addressing one of the key limitations of conventional therapies.
This mechanism positions ANKTIVA as a foundational component of ImmunityBio’s Cancer BioShield platform, which integrates cytokine-based immunotherapy, cell-based therapies, and vaccine strategies to deliver durable anti-tumor responses. The broader goal is to reduce reliance on aggressive treatments like chemotherapy and radiation, while improving long-term survival and quality of life for patients with bladder and prostate cancers.
Source: ImmunityBio press release
