ImmunityBio Inc. (NASDAQ:IBRX) on Tuesday said treatment with Anktiva plus Bacillus Calmette-Guérin (BCG) demonstrates efficacy at 12 and 36 months in patients with BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer (NMIBC).
Published in The Journal of Urology’s current January 2026 print edition, the findings also show tolerable safety that was consistent with BCG treatment alone, with 3% of grade 3 and no grade 4 or 5 treatment-related adverse events (TRAEs).
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Specific key efficacy findings from cohort B (N=80) of the Phase 2/3 open-label, single-arm multicenter QUILT-3.032 study include:
The 12-month disease-free survival (DFS) rate (primary endpoint) was 58.2%; corresponding rates at 24 and 36 months were 52.1% and 38.2%.
Disease-specific survival (DSS) rates were 98.7% at 12 months and 96% at 36 months; the median DSS has not been reached.
Progression-free survival (PFS) rates were 94.9% at 12 months and 83.1% at 36 months.
Cystectomy avoidance (focuses on bladder-preserving strategies for bladder cancer) rates at 12 and 36 months were 92.2% and 81.8%.
The safety profile of Anktiva (nogapendekin alfa inbakicept-pmln) plus BCG was tolerable and consistent with BCG alone.
“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,” added Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio.
Anktiva is currently approved by the U.S. Food and Drug Administration, the U.K., and Conditional Marketing Authorization by the European Union with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
On Friday, the European Medicines Agency recommended granting a conditional marketing authorization for Anktiva in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.
Price Action: IBRX stock is down 1.35% to $2.186 as of Tuesday’s last check.
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