- ANKTIVA® plus BCG shows unmatched long-term bladder preservation in over 80% of responders for 36 months.
- The QUILT-3.032 study reported a 71% complete response rate in BCG-unresponsive NMIBC CIS with or without papillary disease.
- ImmunityBio, Inc. (IBRX, Financial) announces submission of a supplemental BLA to the FDA for papillary disease without CIS indication.
In a recent announcement, ImmunityBio, Inc. (IBRX) shared compelling long-term results from its QUILT-3.032 study of ANKTIVA® plus Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary disease. The study, presented at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, demonstrated a complete response rate of 71% in patients with BCG-unresponsive NMIBC CIS, with some responses lasting over 53 months.
Key findings also highlighted an 84% cystectomy avoidance rate at 36 months, underscoring ANKTIVA's potential for bladder preservation. Among patients with papillary disease without CIS, the data revealed a 58% disease-free survival rate at 12 months, alongside an 82% rate of cystectomy avoidance at 36 months. These outcomes are currently unmatched by other products in this therapeutic area.
ImmunityBio has submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA to expand ANKTIVA's use for papillary disease without CIS, aiming to address this prevalent condition more effectively. With these promising results, ANKTIVA positions itself as a potential best-in-class therapy for BCG-unresponsive NMIBC.
