ImmunityBio plans year-end FDA filing after reporting bladder cancer trial gain over BCG

ImmunityBio has set up a possible expansion of its Anktiva label into earlier-stage bladder cancer. On 9 November 2026 it said the combination of Anktiva and BCG outperformed BCG alone in the first cohort of its randomised QUILT-2.005 study. It plans to ask the US Food and Drug Administration to approve the new use by the end of 2026.

The cohort enrolled patients with high-grade non-muscle invasive bladder cancer and carcinoma in situ who had not previously received BCG. ImmunityBio puts enrolment at 370. It describes the difference between the arms as statistically significant, but the information available does not say which measure was tested, how large the gap was or what the p-value was. Without those, the commercial weight of the result cannot be judged.

On safety, the company says adverse events were in line with those seen with BCG by itself. It has not published the adverse-event breakdown behind that statement.

The route to market is a supplemental Biologics License Application, the mechanism for widening the approved use of a biologic that is already licensed. The filing would concern a patient group different from the one covered by the product's earlier indications. ImmunityBio has said full data will be presented at a medical meeting, but has not named the congress or the date. Until then the findings rest on the company's own account.