ImmunityBio Inc. confirmed that its Independent Data Monitoring Committee has determined the pivotal QUILT‑2.005 trial for ANKTIVA plus Bacillus Calmette‑Guérin (BCG) in BCG‑naïve patients with non‑muscle invasive bladder cancer (NMIBC) and carcinoma in situ has sufficient statistical power. The review concluded that the current enrollment of 366 participants is adequate to detect the pre‑specified clinically meaningful difference in complete response rates between the experimental arm and BCG alone, eliminating the need for additional enrollment.
The confirmation is a critical milestone that de‑risks the trial and underpins the company’s plan to submit a supplemental Biologics License Application in the fourth quarter of 2026. By proving that the study is adequately powered, ImmunityBio can proceed with confidence that its data will support regulatory approval and a commercial launch in the BCG‑naïve NMIBC population, a larger addressable market than the currently approved BCG‑unresponsive indication.
"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.” Patrick Soon‑Shiong, Founder and Executive Chairman, added, "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." Richard Adcock, President and CEO, commented, "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. 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."
The FDA issued a warning letter to ImmunityBio on March 13, 2026 regarding misleading promotions of ANKTIVA. That regulatory action is a separate event and does not affect the current trial milestone. No immediate market reaction to the IDMC confirmation has been reported, but the announcement is expected to reinforce investor confidence in the company’s clinical development strategy.
The company will move forward with the planned Q4 2026 sBLA submission, leveraging the confirmed statistical power to support regulatory approval and a broader commercial launch in the BCG‑naïve NMIBC population.
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