ImmunityBio Says ANKTIVA Plus BCG Meets Primary Endpoint In Phase 3 NMIBC Trial, Supports Planned FDA Filing

• ANKTIVA® plus BCG met the primary efficacy endpoint in the randomized registrational trial of 370 subjects comparing intravesical ANKTIVA plus BCG with BCG alone; additional study details will be presented at an upcoming medical congress
• ANKTIVA plus BCG is the first chemotherapy-free immunotherapy administered directly into the bladder to prolong BCG therapy, the current standard of care, in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC)
• The most common treatment-emergent adverse events with ANKTIVA plus BCG were consistent with BCG alone; no treatment-related deaths were reported
• Patient-reported quality of life was maintained, and median duration of response had not yet been reached with ANKTIVA plus BCG
• A supplemental Biologics License Application (sBLA) remains on track for submission to the FDA by year-end 2026, potentially expanding ANKTIVA’s indication to include patients with NMIBC earlier in their disease course

ImmunityBio, Inc. ((IBRX), a commercial-stage immunotherapy company, today announced positive results from the final analysis of the primary endpoint in Cohort A of QUILT-2.005 (NCT02138734), a randomized, controlled, registrational trial evaluating intravesical ANKTIVA® (nogapendekin alfa inbakicept-pmln/N-803) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve, high-grade non-muscle invasive bladder cancer (NMIBC). The chemotherapy-free combination demonstrated a statistically significant improvement in efficacy compared with BCG alone in patients with carcinoma in situ (CIS), with or without papillary tumors.

The trial involved over 75 clinical trial sites with three largest enrolling sites at US Urology Partners, Dartmouth-Hitchcock, and University of California Los Angeles. Additional study details will be presented at an upcoming medical congress.