ImmunityBio Inc. (IBRX) delivered encouraging long-term results Tuesday for its bladder cancer treatment Anktiva, showing the combination therapy maintains its effectiveness well beyond the initial treatment period.
The company reported that Anktiva combined with Bacillus Calmette-Guérin (BCG) continues demonstrating strong efficacy at 12 and 36 months in patients with BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer. This matters because BCG-unresponsive disease represents a particularly challenging patient population where standard treatments have already failed.
The results, published in The Journal of Urology's January 2026 print edition, also highlighted a manageable safety profile consistent with BCG treatment alone. Only 3% of patients experienced grade 3 treatment-related adverse events, with no grade 4 or 5 events reported.
Breaking Down the Numbers
The Phase 2/3 QUILT-3.032 study's cohort B enrolled 80 patients in an open-label, single-arm multicenter trial. Here's what the data showed:
The 12-month disease-free survival rate, which served as the primary endpoint, came in at 58.2%. That figure declined to 52.1% at 24 months and 38.2% at 36 months, showing durability even as time progressed.
Disease-specific survival rates proved even more impressive: 98.7% at 12 months and 96% at 36 months. The median disease-specific survival hasn't been reached, meaning most patients are still alive without their cancer progressing.
Progression-free survival rates stood at 94.9% at 12 months and maintained 83.1% at 36 months. Meanwhile, cystectomy avoidance, which focuses on bladder-preserving strategies, reached 92.2% at 12 months and 81.8% at 36 months. That's significant because avoiding bladder removal surgery dramatically improves quality of life for patients.
"The 12- and 36-month rates for disease-free, progression-free, and disease-specific survival seen in this study are higher than those reported for other investigational therapies in this patient population," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio.
Regulatory Progress
Anktiva (nogapendekin alfa inbakicept-pmln) already has regulatory traction. The U.S. Food and Drug Administration, the U.K., and the European Union have granted approval or conditional marketing authorization for Anktiva with BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
Just last Friday, the European Medicines Agency recommended granting conditional marketing authorization for Anktiva combined with BCG for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ.
Price Action: IBRX stock traded down 1.35% to $2.186 at Tuesday's last check.
