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ImmunityBio Reports Long-Term Bladder Cancer Study Results for ANKTIVA

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IBRX$8.57 −6.70%

ImmunityBio, Inc. (NASDAQ:IBRX) published long-term results from its Phase 2/3 QUILT-3.032 trial evaluating its immunotherapy ANKTIVA alongside Bacillus Calmette-Guerin for non-muscle invasive bladder cancer. The study demonstrated a 71% complete response rate with a median response duration of 26.6 months. More than half of responding patients maintained complete responses past 45 months, with overall responses extending beyond 53 months.

The trial data highlights high survival rates and a favorable safety profile. Responding patients recorded an 84% cystectomy-free survival rate at 36 months, an 80.9% progression-free survival rate at three years, and a 98.2% disease-specific survival rate over the same period. No Grade 4 or Grade 5 treatment-related adverse events were reported, reinforcing the clinical support for ANKTIVA, which received initial Food and Drug Administration approval in 2024 and expanded label approval earlier this month.

Investors are tracking how these published clinical findings and recent label expansion translate into broader adoption as shares move through key technical levels. While the stock remains well above its 200-day moving average, near-term momentum has cooled, leaving market participants focused on whether the share price can overcome resistance near $11.00 or hold above its 50-day trend line.

Key points

  • ImmunityBio published Phase 2/3 study data for ANKTIVA showing a 71% complete response rate in patients with non-muscle invasive bladder cancer.
  • The treatment demonstrated a median response duration of 26.6 months, with over half of responders maintaining complete responses past 45 months.
  • Patients achieved an 84% cystectomy-free survival rate at 36 months and a 98.2% three-year disease-specific survival rate, with no Grade 4 or 5 adverse events.
  • The publication supports ANKTIVA, an FDA-approved IL-15 receptor agonist whose label was expanded earlier this month to include papillary-only disease.

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Questions and answers

What were the results of ImmunityBio's ANKTIVA bladder cancer study?

The Phase 2/3 study showed a 71% complete response rate with a median duration of 26.6 months. Responders achieved an 84% cystectomy-free survival rate at 36 months and a 98.2% disease-specific survival rate at three years, with no Grade 4 or 5 treatment-related adverse events reported.

Is ANKTIVA approved by the FDA for bladder cancer?

Yes, ANKTIVA was initially approved by the FDA in 2024 for non-muscle invasive bladder cancer and expanded earlier this month to cover patients with papillary-only disease.

How long did complete responses last in the ImmunityBio trial?

Responses extended past 53 months, with more than half of responding patients maintaining complete responses past 45 months.