On March 26, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated, commercial-stage immunotherapy company, reported that based on the Independent Data Monitoring Committee (IDMC) review of the interim data, the committee recommended that the study is adequately powered to detect the pre-specified clinically meaningful difference in complete response (CR) rate between the experimental arm (ANKTIVA + BCG) and the control arm (BCG alone) at the protocol-specified power, in the randomized QUILT-2.005 (NCT02138734) study. The QUILT-2.005 study was designed to detect the pre-specified difference in CR rate between ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) and BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease, based on its review of the planned interim analysis.

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On February 26, 2026, ImmunityBio announced enrollment was complete in the pivotal randomized trial. By March 2026, 50% of enrolled patients were evaluable (N=183) for the primary efficacy endpoint. Upon reaching this pre-specified 50% evaluable threshold, a planned interim analysis by an IDMC was initiated per protocol to verify that the 366 patients enrolled to date provides sufficient statistical power to detect the pre-specified clinically meaningful difference in CR rate between the two arms.

Based on the IDMC review of the interim data, the committee recommended that no additional enrollment beyond N=366 is required and that the study is adequately powered to detect the pre-specified clinically meaningful difference in CR rate at the protocol-specified power.

"Over the past decade, our scientific thesis has been that activating natural killer cells and CD8+ cytotoxic T cells through IL-15 receptor agonism would generate durable immunological memory against bladder cancer. The NCI identified IL-15 as the number one ranked immunostimulatory cytokine nearly two decades ago, and this program has been the clinical validation of that thesis. The IDMC’s confirmation that QUILT-2.005 is adequately powered to detect clinically meaningful differences when ANKTIVA is combined with BCG. Among participants from the QUILT 2.005 Phase 1b study which began in 2014, those patients who enrolled in long-term follow-up (6 of 9 evaluable), all (6 out of 6, 100%) demonstrated a prolonged duration of complete remission with a median survival of 8.8 years with ongoing bladder preservation to date. In addition, the initial interim analysis of QUILT-2.005 performed in the first 43 patients in 2023, further demonstrated a difference in durable complete response when ANKTIVA is combined with BCG in the BCG-naïve setting. The consistency of durable response from the first 9 patients in 2014, to the next 43 patients in 2023 is encouraging and I am pleased that statistical power of the randomized trial requires no further enrollment," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. "The combination of ANKTIVA with BCG is approved for adult patients with BCG-unresponsive NMIBC with CIS with or without papillary disease, and the enrollment of QUILT-2.005 is now complete. ImmunityBio is on track to submit a supplemental Biologics License Application based on the final data analysis in 2026."

"The regulatory and commercial development of ANKTIVA in urologic oncology and across solid tumor indications continues to advance. We are grateful to the patients who participated in this trial and to the ImmunityBio team whose work made this milestone possible," said Richard Adcock, President and CEO of ImmunityBio. "With ANKTIVA approved with BCG for adult patients with BCG-unresponsive NMIBC CIS with or without papillary disease in 34 countries and territories, the opportunity to extend its use earlier in the disease course in the BCG-naïve setting represents a substantial expansion of the addressable patient population."

About QUILT-2.005

QUILT-2.005 (NCT02138734) is a randomized, controlled Phase 2b clinical trial evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC). BCG-naïve patients are those receiving BCG-based therapy for the first time, representing an earlier stage of treatment than the BCG-unresponsive population for whom ANKTIVA is currently FDA approved. The trial is designed to assess whether the addition of ANKTIVA to standard induction BCG improves the complete response (CR) rate in patients with carcinoma in situ (CIS) with or without papillary disease. QUILT-2.005 completed enrollment in February 2026. In March 2026, the Independent Data Monitoring Committee determined that the study was adequately powered to detect a clinically meaningful difference between the control and experimental arms. Supplemental BLA submission is anticipated Q4 2026.

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 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 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.

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, MAR 26, 2026, View Source [SID1234663942])