ImmunityBio Engages FDA on ANKTIVA® Resubmission for Bladder Cancer Treatment

ImmunityBio, Inc., based in Culver City, California, is advancing its treatment options for bladder cancer. The company has engaged with the U.S. FDA regarding its resubmission of the supplemental Biologics License Application (sBLA) for ANKTIVA® (nogapendekin alfa inbakicept), paired with Bacillus Calmette-Guérin (BCG). This application targets patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) featuring papillary tumors.

Collaboration with the FDA

Recently, ImmunityBio held a Type B End-of-Phase meeting with the FDA to discuss the clinical status of its papillary disease program. The FDA recommended that the company provide additional information to support the resubmission. This information compilation is anticipated to be submitted within 30 days. It is noteworthy that this does not involve initiating new clinical trials.

Clinical Data Highlights

• Durable disease-specific survival rate of approximately 96% at 36 months.
• High rates of cystectomy avoidance: 92% at one year and 82% at three years.
• Median survival has not yet been reached after five years of follow-up.

Key physicians presented real-world treatment approaches that highlight the urgent need for alternatives to radical cystectomy, particularly for patients with BCG-unresponsive disease.

Long-Term Study Results

The proposed submission is largely based on findings from the QUILT-3.032 Phase 2/3 trial, which evaluated 80 patients with BCG-unresponsive high-grade papillary-only NMIBC. Recent results published in The Journal of Urology report:

• A 12-month disease-free survival rate of 58.2%.
• A 36-month disease-specific survival rate of 96%. (Median not yet reached)
• Progression-free survival rates of 94.9% at 12 months and 83.1% at 36 months.
• Cystectomy-free survival rates of 92.2% at 12 months and 81.8% at 36 months.

These data demonstrate that ANKTIVA® offers a significant bladder preservation benefit, capable of delaying or preventing the need for radical surgery. If approved, it would be the first immunotherapy option for this challenging patient population.

Regulatory Approvals

ANKTIVA® has received approval in various regions, including:

• FDA approval for carcinoma in situ (CIS) with or without papillary tumors in April 2024.
• UK’s MHRA approval and a positive opinion for Conditional Marketing Authorization in the EU.
• Approval from the Saudi Food and Drug Authority (SFDA) in January 2026.

ImmunityBio is actively seeking discussions with additional international regulatory agencies to broaden access to ANKTIVA® for patients with papillary-only disease.

The Unmet Need in Bladder Cancer Treatment

High-grade papillary NMIBC that does not respond to BCG remains a critical medical challenge. Radical cystectomy is typically the only option, presenting significant risks and impacts on patients’ quality of life. ImmunityBio’s goal is to provide a less invasive treatment that preserves the bladder while targeting cancer effectively.

In summary, ImmunityBio is committed to offering ANKTIVA® as a viable alternative for patients with no approved treatment options, aiming to reshape the therapeutic landscape for BCG-unresponsive papillary NMIBC. The company’s collaborative efforts with the FDA and ongoing clinical studies illustrate its dedication to addressing this urgent unmet need in bladder cancer care.