ImmunityBio’s Trial: ANKTIVA Plus BCG Shows Promising Results in Bladder Cancer Study
Interim Results Show Significant Improvement in Complete Response Duration
ImmunityBio (NASDAQ: IBRX) completed enrollment ahead of schedule in a pivotal Phase 2 trial evaluating ANKTIVA plus BCG versus BCG alone for patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) carcinoma in situ. All 366 participants have been randomized across both treatment arms, positioning the company for timely analysis and future regulatory milestones.
Key Trial Data: Benefit of Combination Strategy
The interim data, requested by the FDA, displayed a significant clinical benefit: after six months, 85% of patients receiving ANKTIVA plus BCG maintained a complete response—compared to 57% with BCG alone. By nine months, complete response rates were 84% for the combination, versus 52% for BCG alone. This difference reached statistical significance (p=0.0455), despite the limited size of the interim sample.
| Time Point | ANKTIVA + BCG | BCG Alone | P-Value |
|---|---|---|---|
| 6 Months | 85% | 57% | - |
| 9 Months | 84% | 52% | 0.0455 |
Safety Profile Remains Encouraging
No new or worsening safety signals emerged with the combination therapy, underscoring the favorable tolerability profile observed in prior studies. This finding is notable, as safety concerns often limit the use of combination regimens in NMIBC, especially after previous failed attempts with immune checkpoint inhibitors paired with BCG.
Upcoming FDA Submission and Expanded Access Program
Building on these results, ImmunityBio plans to submit a Biologics License Application (BLA) to the FDA by the fourth quarter of 2026. Meanwhile, the company’s Expanded Access Program for recombinant BCG continues, with 580 patients currently enrolled, offering an alternative source of BCG amidst ongoing national shortages.
Potential Shift in Standard of Care for Bladder Cancer Treatment
If the final trial data confirms these interim results, ANKTIVA combined with BCG could become a new frontline treatment for BCG-naïve NMIBC patients. This would represent a major addition to the current standard of care, especially given the historical limitations of BCG alone in achieving durable responses.
What’s Next for Patients and Investors?
While definitive conclusions await the final trial readout in late 2026, the improvement in response durability without added safety risks signals substantial progress for patients with early-stage bladder cancer. As the regulatory process continues, ImmunityBio’s efforts will be closely watched for their potential to transform NMIBC treatment—opening up a new therapeutic option at a time of ongoing supply challenges and unmet clinical needs.
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