Unmatched Long-Term Bladder Preservation for 36 Months in over 80 percent of Responders with ANKTIVA Plus BCG in BCG-Unresponsive NMIBC CIS and Papillary Disease Alone – Best in Disease and Best in Class with 5 Year Follow-Up

ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced positive long-term results from its QUILT-3.032 study of ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary disease. The findings were shared during an oral presentation at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, April 26-29.

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AUA 2025 Presentation by Sam Chang, MD

At the 2025 AUA Annual Meeting, ImmunityBio presented updated clinical data highlighting the durability and impact of ANKTIVA in combination with BCG. The results demonstrated the longest duration of complete response and highest rate of cystectomy avoidance among therapies studied in BCG-unresponsive NMIBC, including both CIS with or without papillary disease and papillary-only disease without CIS.

The latest results from Cohort A (N=100) of the QUILT-3.032 study showed treatment with ANKTIVA plus BCG resulted in a complete response rate of 71% in patients with BCG-unresponsive NMIBC CIS with or without papillary tumors. Responses ranged up to more than 53 months, with 60% of responses having a duration of at least 12 months. Exceptional ongoing complete response data were presented for the FDA label population (N=77), which has a longer follow-up time of 29.3 months and showed a 51% probability of duration of complete response of at least 45 months. The rate of cystectomy avoidance in responders was 84.2% at 36 months, with disease-specific overall survival of 99% at 36 months.

In study Cohort B (N=80) of patients with BCG-unresponsive NMIBC papillary disease without CIS, ANKTIVA plus BCG demonstrated a 58.2% disease-free survival (DFS) rate at 12 months (primary endpoint), with a median DFS of 25.3 months. The cystectomy avoidance rate was 82% at 36 months, with a disease-specific overall survival rate of 96% at 36 months.

“While BCG is the commonly used first-line therapy for newly diagnosed high-risk non-muscle invasive bladder cancer, many patients will be refractory or relapse after an initial response and be diagnosed as BCG-unresponsive,” said QUILT-3.032 principal investigator and study presenter Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center. “Our latest findings, including an 82% cystectomy avoidance rate, provide additional evidence that ANKTIVA has the ability to restore BCG activity and promote durable complete responses and, most importantly, help patients preserve their bladder for a prolonged duration from surgery in both CIS, as well as papillary without CIS disease.”