ImmunityBio Advances Toward Key Regulatory Submission for Bladder Cancer Therapy

ImmunityBio completes Phase 2 enrollment for its ANKTIVA+BCG bladder cancer therapy. Positive interim data supports a planned 2026 FDA application, while the company also addresses BCG supply shortages.

ImmunityBio has achieved a significant clinical milestone ahead of schedule, bringing its lead oncology candidate a step closer to potential U.S. approval. The biotechnology firm announced it has completed patient enrollment for a pivotal Phase 2 study evaluating its combination therapy for bladder cancer.

Clinical Trial Progress and Regulatory Pathway

The company’s QUILT 2.005 trial, a randomized clinical study, has now fully enrolled 366 participants. These patients, all diagnosed with BCG-naïve non-muscle invasive bladder cancer carcinoma in situ, have been assigned to one of two treatment groups. The research directly compares a therapeutic regimen combining ImmunityBio’s ANKTIVA with Bacillus Calmette-Guérin (BCG) against the standard treatment of BCG alone.

Notably, an interim analysis requested by the U.S. Food and Drug Administration (FDA) has already yielded positive data. The analysis indicated a statistically significant benefit for the combination therapy, showing a longer duration of complete response compared to treatment with BCG by itself. Based on these encouraging results, ImmunityBio is preparing to file a Biologics License Application (BLA) with the FDA in the fourth quarter of 2026. Additional data from the study is anticipated around the same timeframe.

Addressing Treatment Supply Challenges

In a related development, the company is actively working to mitigate a persistent shortage of TICE BCG, a critical component of the standard care. ImmunityBio has initiated an Expanded Access Program for a recombinant version of BCG (rBCG). Furthermore, it has requested a formal consultation with the FDA, with the objective of securing regulatory approval for rBCG as an alternative supply source for this essential therapeutic agent.

Upcoming Financial and Pipeline Updates

Looking ahead, ImmunityBio has scheduled a comprehensive update for investors on March 3, 2026. On that date, the company will release its complete financial results for the 2025 fiscal year and provide a detailed overview of progress across its entire clinical development pipeline.