ImmunityBio, Inc.

ImmunityBio Announces Database Lock for Registrational Trial of Locally Delivered, Chemotherapy-Free ANKTIVA® Plus BCG in BCG-Naïve Non-Muscle Invasive Bladder Cancer

Database lock completed for Cohort A of QUILT-2.005 (NCT02138734), a randomized, controlled registrational trial comparing ANKTIVA® plus BCG with BCG alone in 366 patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC)

ANKTIVA plus BCG is being evaluated as the first locally delivered, chemotherapy-free combination immunotherapy for BCG-naïve NMIBC

Final analysis of the trial’s primary efficacy endpoint is underway, with topline results expected in November 2026

Supplemental Biologics License Application (sBLA) submission remains on track for the fourth quarter of 2026, potentially expanding ANKTIVA’s indication to include patients with BCG-naïve NMIBC earlier in their disease course | $IBRX

ImmunityBio Reports Phase 3 Data Showing 84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC With CIS, With or Without Papillary Tumors

Peer-reviewed publication reports long-term outcomes from the QUILT-3.032 study supporting durable disease control and bladder preservation | $IBRX

FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease

Expanded indication extends ANKTIVA plus BCG to patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC), including those with carcinoma in situ (CIS), with or without papillary tumors, and those with papillary-only tumors

Papillary disease represents approximately 85% of the NMIBC patient population1

This is the first FDA approval to include BCG-unresponsive NMIBC with papillary-only tumors

With this FDA approval, access to ANKTIVA plus BCG expands to include all patients with BCG-unresponsive NMIBC | $IBRX

ImmunityBio to Participate in the Piper Sandler Virtual Oncology Symposium | $IBRX