ImmunityBio's Bladder Cancer Trial Data Paves Path for Regulatory Filing

ImmunityBio's ANKTIVA® Phase 2 trial interim results show 84% response in bladder cancer, driving 700% sales growth and a planned 2026 FDA submission.

ImmunityBio has successfully completed patient enrollment for its pivotal Phase 2 study of ANKTIVA® ahead of schedule, with interim results surpassing expectations. This development could create a significant strategic opportunity for the biotechnology firm.

Commercial Momentum and Financial Position

The company is building substantial commercial traction for ANKTIVA®. For the full year 2025, the therapy generated net sales of approximately $113 million, representing a surge of roughly 700% compared to the prior year. Fourth-quarter 2025 sales alone reached $38.3 million.

The drug is now approved in 33 countries, including the United States, the European Union, the United Kingdom, and Saudi Arabia. In Europe, ImmunityBio collaborates with Accord Healthcare, while its partnership in Saudi Arabia is with BioPharma & Cigalah. Notably, in Saudi Arabia, ANKTIVA® received its first approval for use in lung cancer in combination with checkpoint inhibitors. As of the end of 2025, ImmunityBio reported a cash position of $242.8 million.

Strong Interim Results from QUILT 2.005 Trial

The clinical advance stems from the QUILT 2.005 study, which evaluated ANKTIVA® in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-naïve non-muscle invasive bladder cancer. The trial enrolled a total of 366 participants.

At the nine-month mark, 84% of patients receiving the combination therapy continued to show a complete response. This significantly outperformed the control group receiving BCG alone, where the complete response rate was 52%. The efficacy advantage was consistent at six months, with an 85% response rate for the combination versus 57% for BCG monotherapy. According to the company, no new safety concerns emerged from the data.

Targeting a 2026 Submission to Regulators

Based on these compelling interim results, which were provided at the request of the U.S. Food and Drug Administration (FDA), ImmunityBio is now planning to submit a marketing application to the FDA by the fourth quarter of 2026.

The accelerated patient recruitment and superior efficacy data position the company to advance its regulatory strategy for this important oncology asset.