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ANKTIVA® with BCG Demonstrates 96% Survival from Bladder Cancer at Three Years with Median Survival Not Yet Reached in BCG-Unresponsive High-Grade Papillary-Only Non-Muscle Invasive Bladder Cancer
Results from the QUILT-3.032 study of 80 subjects, published in The Journal of Urology, showed 96% disease-specific survival and 83% progression-free
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nResults from the QUILT-3.032 study of 80 subjects, published in The Journal of Urology, showed 96% disease-specific survival and 83% progression-free survival at 36 months, demonstrating the long-term duration of effect of ANKTIVA® in patients with high-grade papillary NMIBC without CIS1\n\n\nHigh cystectomy avoidance rates of 92% and 82% were seen at 12 months and 36 months1, validating the durable response and bladder sparing effect of ANKTIVA plus BCG in this indication\n\n\nANKTIVA plus BCG demonstrated a tolerable safety profile consistent with BCG alone, with 3% of grade 3 and no grade 4 or 5 treatment-related adverse events1\n\n\nThere are currently no approved therapies for BCG-unresponsive papillary-only NMIBC, leaving patients with total radical cystectomy as the alternative despite its high mortality and morbidity\n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced treatment with ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) demonstrates efficacy at 12 and 36 months, including disease-free survival (DFS), disease-specific survival (DSS), long-term progression-free survival (PFS), and high cystectomy avoidance in patients with BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer (NMIBC). Published in The Journal of Urology’s current January 2026 print edition, the findings also show tolerable safety that was consistent with BCG treatment alone, with 3% of grade 3 and no grade 4 or 5 treatment-related adverse events (TRAEs).1\n\nSpecific key efficacy findings from cohort B (N=80) of the Phase 2/3 open-label, single-arm multi-center QUILT-3.032 study include:1\n\n\nThe DFS rate at 12 months (primary endpoint) was 58.2% (95% CI 46.6, 68.2); corresponding rates at 24 and 36 months were 52.1% (95% CI 40.3, 62.7) and 38.2% (95% CI 25.6, 50.6).\n\n\nDSS rates were 98.7% (95% CI 91.4, 99.8) at 12 months and 96.0% (95% CI 88.2, 98.7) at 36 months; the median DSS has not been reached.\n\n\nPFS rates were 94.9% (95% CI 86.9, 98.0) at 12 months and 83.1% (95% CI 69.5, 91.0) at 36 months.\n\n\nCystectomy avoidance rates at 12 and 36 months were 92.2% (95% CI 83.4, 96.4) and 81.8% (95% CI 68.1, 90.1).\n\n\nThe safety profile of ANKTIVA plus BCG, which was assessed for study cohorts A and B (N=1...