On October 16, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported the publication of long-term data from the Phase 2/3 QUILT-3.032 study (N=100) in the Journal of Urology. The study evaluated ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease.
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Highlights:
71% complete response (CR) rate in patients with BCG-unresponsive NMIBC CIS, with or without papillary disease
Median duration of CR of 26.6 months, with responses extending beyond 53 months
More than half of responding patients in the FDA-reviewed population maintained complete responses beyond 45 months
84% cystectomy-free survival at 36 months among responders
98.2% disease-specific survival at three years
No Grade 4 or Grade 5 treatment-related adverse events reported
"The QUILT-3.032 study represents one of the longest follow-up data sets in BCG-unresponsive NMIBC to date, and the results continue to support the durability of ANKTIVA’s unique mechanism of action in generating sustained immune responses," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "These long-term findings are encouraging, suggesting the potential for prolonged disease control and the possibility of avoiding or delaying radical cystectomy for some patients."
The publication also reported:
63.8% of responders maintained CR for at least 12 months
52.3% maintained CR for at least 24 months
44.2% maintained CR for at least 36 months
Progression-free survival remained 80.9% at three years
In BCG refractory (never responded) patients, the CR rate was 66%
4% of responders progressed to muscle-invasive disease
The treatment continued to demonstrate a favorable safety profile. Most treatment-related adverse events were Grade 1 or Grade 2 and consisted of localized bladder symptoms associated with intravesical therapy. Grade 3 treatment-related adverse events occurred in 4% of patients, with no Grade 4 or Grade 5 treatment-related adverse events reported.
"Achieving a durable response and avoiding cystectomy are important treatment goals for patients with BCG-unresponsive NMIBC," said Richard Adcock, President and CEO of ImmunityBio. "These peer-reviewed results add to the growing body of evidence supporting ANKTIVA plus BCG and highlight its potential to provide sustained disease control and meaningful cystectomy avoidance for patients with limited treatment options. We thank the patients and clinical teams who contributed to this long-term follow-up."
The publication builds upon the growing body of clinical evidence supporting ANKTIVA plus BCG, which was initially approved by the U.S. Food and Drug Administration (FDA) in 2024 for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In October 2026, the FDA expanded the approved indication to include patients with BCG-unresponsive NMIBC with papillary-only disease. ANKTIVA is the first FDA-approved IL-15 receptor agonist and the first approved immunotherapy in NMIBC designed to activate natural killer (NK) cells and T cells to generate durable immune responses.
About the QUILT 3.032 Study
QUILT-3.032 (NCT03022825) is a multicenter Phase 2/3 study evaluating ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC. The published analysis includes 100 patients with CIS with or without papillary disease and represents one of the longest follow-up datasets reported in this disease setting, with outcomes extending beyond five years in some patients.
About ANKTIVA (nogapendekin alfa inbakicept-pmln)
The interleukin-15 (IL-15) cytokine 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 agonist 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 membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and 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.
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.
DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.
Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.
(Press release, ImmunityBio, OCT 16, 2026, View Source [SID1234673523])