ImmunityBio’s QUILT-2.005 Trial Meets Power Goals, No Additional Enrollment Needed, IDMC Confirms Adequate Power In Bladder Cancer Study

ImmunityBio, Inc. announced that an Independent Data Monitoring Committee (IDMC) has confirmed that its ongoing Phase 3 QUILT-2.005 study is sufficiently powered to detect a clinically meaningful difference in complete response (CR) rates. The trial is 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).

"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 study focuses on patients with carcinoma in situ (CIS), with or without papillary disease, and aims to assess whether combination therapy improves CR rates compared with standard treatment. The IDMC’s recommendation follows a planned interim analysis conducted after 50% of enrolled patients became evaluable for the primary endpoint.

Enrollment in the pivotal trial was completed in February 2026, with 366 patients participating. By March 2026, 183 patients had reached evaluable status, triggering the interim review. Based on this analysis, the committee determined that the current sample size is adequate and that no further patient enrollment is necessary.

“The regulatory and commercial development of ANKTIVA in urologic oncology and across solid tumour 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.”

This outcome supports the study’s statistical robustness and keeps the trial on track to evaluate the efficacy of ANKTIVA® in improving treatment outcomes for patients with NMIBC.