ImmunityBio Reports Long-Term ANKTIVA Data in Bladder Cancer

CULVER CITY, Calif., October 16, 2026

Durable Complete Responses and Bladder Preservation

The published analysis reported a median complete response duration of 26.6 months, with responses extending beyond 53 months in some patients. Among responding patients, 63.8% maintained complete responses for at least 12 months, 52.3% for at least 24 months and 44.2% for at least 36 months. The company also reported that more than half of responding patients in the FDA-reviewed population maintained complete responses beyond 45 months. Cystectomy-free survival was 84% at 36 months among responders, indicating that most patients in this group had not undergone surgical removal of the bladder by that time point. Progression-free survival remained 80.9% at three years, and 4% of responders progressed to muscle-invasive disease. Among patients with BCG-refractory disease, defined in the release as patients who had never responded to BCG, the complete response rate was 66%. These outcomes are relevant because radical cystectomy is a major treatment option for patients whose bladder cancer no longer responds to BCG. However, the results do not mean surgery can be safely delayed for every patient; treatment decisions require individualized assessment of response, disease progression and clinical risk.

Safety Findings and ANKTIVA’s Immune Mechanism

ImmunityBio reported that the combination maintained a favorable safety profile during follow-up. Most treatment-related adverse events were Grade 1 or Grade 2, primarily localized bladder symptoms associated with intravesical therapy. Grade 3 treatment-related adverse events occurred in 4% of patients, and no Grade 4 or Grade 5 treatment-related adverse events were reported. ANKTIVA is an interleukin-15 (IL-15) receptor agonist designed to activate and expand immune cells involved in antitumor responses, including natural killer (NK) cells and T cells. Its fusion-complex design combines an IL-15 mutant with the IL-15 receptor alpha component to engage IL-15 receptors on immune cells. The intended effect is to support innate and adaptive immune activity and promote immune memory. Patrick Soon-Shiong, M.D., ImmunityBio’s Founder, Executive Chairman and Global Chief Scientific and Medical Officer, said the extended follow-up provides evidence of sustained responses and potential prolonged disease control. President and CEO Richard Adcock added that durable responses and cystectomy avoidance are important treatment goals for people with BCG-unresponsive NMIBC.

Regulatory Status and Clinical Significance

ANKTIVA plus BCG received initial U.S. Food and Drug Administration (FDA) approval in 2024 for adults with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. According to the company, in October 2026 the FDA expanded the approved indication to include patients with BCG-unresponsive NMIBC with papillary-only disease. The QUILT-3.032 study (NCT03022825) is a multicenter Phase 2/3 trial, and the published analysis represents one of the longer follow-up data sets reported by the company for this disease setting, with outcomes extending beyond five years in some patients. The prescribing information includes an important warning that delaying cystectomy can allow bladder cancer to progress to muscle-invasive or metastatic disease, which can be life-threatening. For patients with CIS who do not achieve a complete response after a second induction course of ANKTIVA plus BCG, cystectomy should be reconsidered in accordance with the prescribing information. ANKTIVA is for intravesical use only and must not be administered intravenously or subcutaneously. The long-term findings add to the evidence base for this treatment combination, while ongoing clinical evaluation and individualized medical decisions remain important to determining appropriate care.

Source::ImmunityBio,press release