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ImmunityBio locks database for ANKTIVA plus BCG bladder cancer trial

ImmunityBio has finished the database lock for the QUILT-2.005 trial. Topline results are expected in November 2026, according to TradingView and Reuters.

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what happened

ImmunityBio said it has completed the data review, verification and reconciliation for Cohort A of QUILT-2.005. The trial compares ANKTIVA combined with BCG against BCG alone in patients with non-muscle invasive bladder cancer who have not previously received BCG. A total of 366 patients were enrolled. According to the company's press release, carried by TradingView and Reuters, the final analysis of the primary endpoint has now begun.

The U.S. Food and Drug Administration had requested an interim analysis, which the company says showed that complete response lasted significantly longer on the combination than on BCG alone. ImmunityBio expects to report topline data in November 2026 and still plans to file an sBLA with the regulator in the final quarter of 2026 for this patient group.

why it matters

For investors, the key catalyst remains the November topline readout. A positive outcome could widen ANKTIVA's label beyond patients unresponsive to BCG, which is currently its only approved use. The release contained no new efficacy figures, so the stock reaction will depend on the data itself rather than on the announcement.

market impact

ImmunityBio stock: November trial data is the main driver for the company's shares.

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ImmunityBio

sources

  1. ImmunityBio Announces Database Lock for Registrational Trial of Locally Delivered, Chemotherapy-Free ANKTIVA® Plus BCG in BCG-Naïve Non-Muscle Invasive Bladder Cancer — TradingView, 21 October 2026 at 11:30 UTC
  2. Immunitybio Announces Database Lock For Registrational Trial Of Locally Delivered, Chemotherapy-Free Anktiva® Plus Bcg In Bcg-Naïve Non-Muscle Invasive Bladder Cancer — Reuters, 21 October 2026 at 12:20 UTC

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