ImmunityBio Announces Data From Its Phase 2/3 QUILT-3.032 Trial Of ANKTIVA In Combination With Bacillus Calmette-Guerin Demonstrates 71% Complete Response Rate In Participants With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ

Benzinga · 1d ago

ImmunityBio, Inc. ((IBRX), a commercial-stage immunotherapy company, today announced the publication of long-term data from the Phase 2/3 QUILT-3.032 study (N=100) in the Journal of Urology. The study evaluated ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease.

  • 71% complete response (CR) rate in patients with BCG-unresponsive NMIBC CIS, with or without papillary disease
  • Median duration of CR of 26.6 months, with responses extending beyond 53 months
  • More than half of responding patients in the FDA-reviewed population maintained complete responses beyond 45 months
  • 84% cystectomy-free survival at 36 months among responders
  • 98.2% disease-specific survival at three years
  • No Grade 4 or Grade 5 treatment-related adverse events reported