Key Takeaways
ImmunityBio Inc. (NASDAQ: IBRX) saw its shares climb after presenting new data from two analyses suggesting its bladder cancer therapy, Anktiva, holds significant advantages over two other FDA-approved treatments. The data, presented at the 2026 American Urological Association Annual Meeting, showed the combination of Anktiva and BCG vaccine produced more durable responses and, in one comparison, a better safety profile for patients with non-muscle invasive bladder cancer (NMIBC).
"The magnitude and durability of complete response observed with NAI+BCG, combined with a meaningful reduction in the risk of cystectomy, are clinically relevant for patients with BCG-unresponsive NMIBC for whom bladder preservation is the priority," said Dr. Brooke B. Edwards of The Urology Group in Cincinnati, OH, who presented the findings.
The new data comes from two separate indirect treatment comparisons. In a comparison against nadofaragene firadenovec-vncg, patients receiving Anktiva plus BCG had a complete response rate of 69.7% versus 53.4% and a median response duration of 22.1 months versus 9.7 months. A second analysis found that patients on the Anktiva regimen experienced significantly fewer treatment-related adverse events of any grade than those on TAR-200 (61.7% versus 83.5%).
For investors, the results reinforce Anktiva's competitive position in a challenging cancer type where effective, bladder-sparing treatments are in high demand. The data provides a compelling case for the drug's efficacy and durability, potentially driving wider adoption by urologists and boosting ImmunityBio's revenue prospects against established competitors.
In the absence of a direct head-to-head trial, ImmunityBio conducted a matching-adjusted indirect comparison (MAIC) using patient data from its own QUILT-3.032 study and published aggregate data for nadofaragene firadenovec-vncg. After adjusting for baseline characteristics, the analysis showed patients treated with Anktiva plus BCG were twice as likely to achieve a complete response at any point in the study (OR 2.01).
Furthermore, the treatment more than doubled the median duration of that response to 22.1 months, a 12.45-month improvement over the 9.7 months seen with nadofaragene. This durability also translated to a 60% reduction in the risk of patients needing a cystectomy, or bladder removal surgery.
A second MAIC analysis compared the Anktiva combination with TAR-200, another approved therapy. While the 12-month complete response rates were not statistically different (49.2% for Anktiva vs. 45.9% for TAR-200), the safety results were notable.
Patients on Anktiva experienced a statistically significant 68% reduction in the odds of any grade of treatment-related adverse events. The study's authors noted the finding was robust, suggesting it is unlikely to be negated by unmeasured confounding factors.
"A duration of complete response more than twice as long as with nadofaragene speaks directly to the central question patients ask: ‘how long will my response last?’" said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. He also highlighted the company's work to address the persistent BCG shortage in the U.S., which has constrained care for bladder cancer patients.
Anktiva is a first-in-class immunotherapy that works by activating key immune cells, including natural killer (NK) cells and T cells, to fight the cancer. The company noted the limitations of unanchored indirect comparisons but stated the results add to the growing body of evidence supporting the therapy's use.
This article is for informational purposes only and does not constitute investment advice.
