ImmunityBio Locks Data for Bladder Cancer Study

The company completed the database lock for its ongoing QUILT-2.005 trial studying the effectiveness of ANKTIVA.

Updated on Oct. 21, 2026 in Cancer

ImmunityBio Locks Data for Bladder Cancer Study

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ImmunityBio has officially locked the database for the QUILT-2.005 clinical trial after enrolling 366 patients. The study compares the combination of ANKTIVA and BCG against BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer.

Why it matters

The trial aims to determine if adding ANKTIVA to standard BCG treatments improves complete response rates and durability for patients. This effort supports the company's goal of seeking an expanded indication for the drug from the FDA.

The QUILT-2.005 trial enrolled 366 patients, with an independent committee reviewing data from 183 evaluable patients earlier this year. ANKTIVA is currently approved for adults with BCG-unresponsive non-muscle-invasive bladder cancer.

The players

ImmunityBio

This biotechnology company focuses on developing therapies for cancers and infectious diseases through immunotherapy and cell therapy platforms.

FDA

The Food and Drug Administration is the federal agency responsible for protecting public health by regulating the safety and efficacy of medical products.

The details

The database lock involved a comprehensive review, verification, and reconciliation of data from all participants in the randomized study. An independent data monitoring committee previously found the trial had sufficient power to detect a clinically meaningful difference between treatment arms.

February 2026: Cohort A completed patient enrollment.
March 2026: An independent committee reviewed 183 evaluable patients.
November 2026: The company expects to report topline study results.
Q4 2026: ImmunityBio plans to submit an sBLA to the FDA.

The Big Picture

This development represents a critical milestone for the QUILT-2.005 clinical trial. It marks the transition from active patient data collection to the final analysis stage required for regulatory review.

This trial progress offers hope for more effective, durable treatment options for patients diagnosed with BCG-naïve non-muscle invasive bladder cancer. If successful, the expanded indication would provide a new therapeutic pathway for individuals currently limited to standard BCG therapy.

The takeaway

The successful database lock underscores the company's commitment to gathering the clinical evidence required for regulatory approval of combination therapies. Patients and providers should monitor upcoming reports for details on the long-term efficacy of this combination treatment.

What happens next

ImmunityBio is scheduled to release topline results from the trial in November 2026, followed by a planned sBLA submission to the FDA in the fourth quarter of 2026.