December 16, 2025 — Leads & Copy — ImmunityBio, Inc. (NASDAQ: IBRX) announced that treatment with ANKTIVA® plus Bacillus Calmette-Guérin (BCG) demonstrates efficacy at 12 and 36 months in patients with BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer (NMIBC).
The findings, published in The Journal of Urology, show disease-free survival (DFS), disease-specific survival (DSS), long-term progression-free survival (PFS), and high cystectomy avoidance. The safety profile was consistent with BCG treatment alone, with 3% of grade 3 and no grade 4 or 5 treatment-related adverse events (TRAEs).
Key efficacy findings from cohort B (N=80) of the Phase 2/3 QUILT-3.032 study include a DFS rate at 12 months of 58.2%. DSS rates were 98.7% at 12 months and 96.0% at 36 months. PFS rates were 94.9% at 12 months and 83.1% at 36 months. Cystectomy avoidance rates at 12 and 36 months were 92.2% and 81.8%, respectively.
According to Dr. Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center, ANKTIVA plus BCG offers a novel and efficacious treatment option for these patients.
Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, stated that the rates for disease-free, progression-free, and disease-specific survival are higher than those reported for other investigational therapies in this patient population.
ANKTIVA is currently approved by the U.S. Food and Drug Administration, United Kingdom and Conditional Marketing Authorization by the European Union with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
Contact: Investors Shirah Ushpiz Shirah.Ushpiz@ImmunityBio.com
Source: ImmunityBio
