Clinical trialsCompany release

ImmunityBio says ANKTIVA plus BCG met primary endpoint in BCG-naïve bladder cancer

🇺🇸 ImmunityBio, Inc. (IBRX) · Mon 09 Nov 2026

The company reports a statistically significant efficacy gain over BCG alone in Cohort A of QUILT-2.005 and plans a supplemental BLA filing by the end of 2026.

ImmunityBio announced on 9 November 2026 the final primary-endpoint analysis of Cohort A in its randomised QUILT-2.005 trial. The company says intravesical ANKTIVA combined with BCG showed a statistically significant improvement in efficacy over BCG alone.

The study population is BCG-naïve patients with high-grade non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. The company's announcement describes the trial as involving 370 patients. The material available to us does not specify the endpoint measure, the size of the effect or the p-value.

On safety, ImmunityBio says adverse events were consistent with those seen with BCG alone. No further safety detail was provided in the information we have reviewed.

The company plans to submit a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration by the end of 2026, and says full data will be presented at a medical congress. An sBLA is the route by which a sponsor asks the FDA to extend or change the approved use of an already licensed biologic. The congress and its date have not been named.

What it means for your team

  • The results are a company announcement; the detailed data, endpoint definition and effect size are not yet public, so independent assessment must wait for the congress presentation.
  • Regulatory teams should watch for the sBLA submission, which the company has targeted for year-end 2026, and for any FDA acceptance or review-timeline news.
  • Pharmacovigilance teams should note the stated safety profile is described as consistent with BCG alone; the full adverse-event tables will be needed to check this.
  • Market-access teams tracking NMIBC should note the study is in BCG-naïve patients, so a label extension would concern a different setting from the one covered by earlier indications.

Company's press release (SEC filing): ImmunityBio, Inc. ↗

Article written by VigiEye from the official source (ImmunityBio, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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