ImmunityBio locks database for bladder cancer trial, eyes 2026 results

ImmunityBio, Inc. (NASDAQ: IBRX) announced the completion of a database lock for Cohort A of QUILT-2.005 (NCT02138734), a randomized, controlled registrational trial 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).

The database lock follows data review, verification, and reconciliation of all 366 randomized patients across 110 U.S. and global clinical sites. Enrollment of Cohort A was completed in February 2026. In March 2026, an Independent Data Monitoring Committee determined that no additional enrollment was required to maintain the study's prespecified statistical power.

A prior interim analysis requested by the U.S. Food and Drug Administration showed statistically significant longer duration of complete response with ANKTIVA plus BCG compared to BCG alone. The final analysis will assess the trial's primary endpoint — complete response rates — along with key secondary endpoints including duration of response.

ImmunityBio said it expects to report topline results in November 2026 and remains on track to submit a supplemental Biologics License Application (sBLA) to the FDA in the fourth quarter of 2026. A successful submission could expand ANKTIVA's current approved indication, which covers BCG-unresponsive NMIBC, to include BCG-naïve patients earlier in their disease course.

"The final analysis of this study will determine whether adding ANKTIVA to BCG improves complete response rates and the durability of those responses when compared with BCG alone," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio.

Richard Adcock, President and Chief Executive Officer, said the database lock brings the company closer to its planned sBLA submission, reflecting the efforts of clinical teams, investigators, and site personnel involved in the trial.

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