ImmunityBio Engages FDA on ANKTIVA® Resubmission for BCG-Unresponsive Bladder Cancer
ImmunityBio, Inc., based in Culver City, California, has announced an important regulatory step regarding ANKTIVA® (nogapendekin alfa inbakicept). The company recently engaged in a Type B End-of-Phase meeting with the U.S. Food and Drug Administration (FDA) to discuss its supplemental Biologics License Application (sBLA) for ANKTIVA combined with Bacillus Calmette-Guérin (BCG) in treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.
Key Meeting Highlights
During the meeting, ImmunityBio presented clinical data that supports the use of ANKTIVA for papillary NMIBC. Key points included:
- Approximately 96% disease-specific survival at 36 months.
- A median survival that remains uncalculated even after five years of follow-up.
- Cystectomy avoidance rates of 92% and 82% at one and three years, respectively.
- A safety profile consistent with the approved use in carcinoma in situ (CIS).
Prominent urologists contributed insights on treatment strategies for BCG-unresponsive cases, highlighting the significant risks of muscle-invasive progression and mortality in patients.
Next Steps for ImmunityBio
The FDA has requested additional information to assist in the consideration of the sBLA resubmission. ImmunityBio aims to provide this information within 30 days. Notably, this does not require initiating a new clinical trial.
Richard Adcock, ImmunityBio’s President and CEO, expressed gratitude for the FDA’s collaboration and emphasized the company’s commitment to delivering viable therapeutic options for patients lacking approved alternatives.
Critical Clinical Data
The proposed submission is bolstered by findings from the QUILT-3.032 Phase 2/3 trial, which involved 80 individuals with high-grade papillary NMIBC unresponsive to BCG. According to recent findings published in The Journal of Urology, the trial met its primary endpoint with a:
- 12-month disease-free survival rate of 58.2% (95% CI: 46.6-68.2).
- 36-month disease-specific survival rate of 96%, with median survival undetermined.
- 94.9% progression-free survival at 12 months, dropping to 83.1% at 36 months.
- Cystectomy-free survival rates of 92.2% and 81.8% at 12 and 36 months, respectively.
These outcomes indicate a promising alternative to radical cystectomy, traditionally the sole option for BCG-unresponsive patients.
Global Regulatory Landscape
ANKTIVA, in combination with BCG, has already received regulatory approvals for treating CIS in various regions. The FDA approved it in April 2024, while the product is also authorized in the UK and has obtained conditional marketing authorization in the EU. Furthermore, the Saudi Food and Drug Authority granted its approval for BCG-unresponsive CIS in January 2026.
Addressing Unmet Medical Needs
High-grade papillary NMIBC that does not respond to BCG presents significant treatment challenges. Radical cystectomy carries considerable risks and impacts quality of life.
ImmunityBio’s exploration of the papillary NMIBC indication aims to offer a non-invasive alternative that can effectively manage the disease while preserving bladder function. If successful, ANKTIVA would be the first immunotherapy option approved for this patient population, potentially transforming their treatment landscape.
About ANKTIVA®
ANKTIVA is designed as a first-in-class IL-15 agonist, enhancing the immune response against cancer. It focuses on promoting the activity of natural killer (NK) cells and CD8+ T cells, restoring T-cell memory and improving treatment outcomes.
About ImmunityBio
ImmunityBio is dedicated to developing cutting-edge therapies that empower the immune system in the fight against cancer and infectious diseases. The company’s approach integrates various immunotherapy platforms aimed at producing durable, effective treatments with fewer side effects.
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