ImmunityBio eyes FDA filing for bladder cancer after trials beat expectations

ImmunityBio (NASDAQ:IBRX) announced on Friday that its mission to redefine the first-line treatment for bladder cancer is moving faster than anticipated, putting a critical regulatory filing within reach for late 2026.

The California-based immunotherapy firm revealed that enrollment in its QUILT-2.005 trial—which tests the company’s lead drug, ANKTIVA, in combination with the standard Bacillus Calmette-Guérin (BCG) vaccine—is now over 85% complete.

Full enrollment is now expected by the second quarter of 2026, ahead of the company's internal projections.

The news comes as interim data highlights a stark contrast in patient outcomes.

In a 2024 analysis requested by the FDA, patients receiving the ANKTIVA-BCG "cocktail" demonstrated an 84% complete response rate at nine months.

By comparison, those receiving BCG alone—the current standard of care—saw the response rate drop to 52%.

The results achieved statistical significance (p=0.0455), suggesting that ANKTIVA acts as a powerful "immune switch" that prevents early relapse.

Beyond the clinical data, ImmunityBio is working to resolve a long-standing headwind for the industry: the chronic shortage of the TICE BCG vaccine.

The company confirmed it is in consultations with the FDA to utilize its own recombinant BCG as an alternative supply source.

If successful, this would allow ImmunityBio to bypass global manufacturing bottlenecks and provide a vertically integrated solution for the thousands of patients diagnosed annually with BCG-naïve non-muscle-invasive bladder cancer.