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.