Highlights

  • ImmunityBio plans to submit FDA-requested information for papillary NMIBC within 30 days.
  • Long-term QUILT-3.032 results show 96% bladder cancer-specific survival at 36 months.
  • Over 80% of patients avoided radical cystectomy after papillary NMIBC treatment.

ImmunityBio, Inc. (NASDAQ:IBRX) recently conducted a Type B End-of-Phase meeting with the U.S. FDA regarding its supplemental Biologics License Application (sBLA) for ANKTIVA® (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG). The application focuses on patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) presenting with papillary tumors.

Following the meeting, the FDA requested additional information to support a potential resubmission. ImmunityBio has compiled the requested data and intends to submit it within 30 days.

Clinical Data Highlight Treatment Outcomes
The QUILT-3.032 Phase 2/3 trial (Cohort B), published in The Journal of Urology (Chang et al., 2025), included 80 patients with BCG-unresponsive high-grade papillary-only NMIBC. Key findings include:

  • Disease-free survival (DFS) at 12 months was 58.2% (95% CI: 46.6–68.2%).
  • Disease-specific survival (DSS) reached 96.0% at 36 months, with median DSS not yet reached.
  • Progression-free survival (PFS) was 94.9% at 12 months and 83.1% at 36 months.
  • Cystectomy-free survival was 92.2% at 12 months and 81.8% at 36 months, suggesting durable bladder preservation.

These results indicate that ANKTIVA plus BCG may reduce the need for radical cystectomy in a significant portion of patients with papillary NMIBC.

Global Regulatory Status
Currently, ANKTIVA is approved for NMIBC carcinoma in situ (CIS), with or without papillary tumors, in the U.S., U.K., and Saudi Arabia, and holds conditional approval in the European Union. ImmunityBio is also engaging with other regulatory authorities, including the European Medicines Agency (EMA), for potential label expansion to papillary-only disease pending U.S. approval.

ANKTIVA Mechanism of Action
ANKTIVA is an interleukin-15 (IL-15) agonist IgG1 fusion complex that activates NK cells and enhances CD8+ T-cell response. This mechanism targets cancer cells resistant to T cells, restoring immune memory and extending complete responses in NMIBC patients.

Stock Performance
IBRX shares surged 39.75% to USD 5.52 per share on January 20, 2026.