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Biotech / Medical : ImmunityBio converts from Immunomedics
IBRX 2.075-1.7%9:40 AM EST
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From: zagnut14/28/2025 8:45:46 AM
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Apr 28, 2025 8:30 AM Eastern Daylight Time

Unmatched Long-Term Bladder Preservation for 36 Months in over 80 percent of Responders with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC CIS and Papillary Disease Alone – Best in Disease and Best in Class with 5 Year Follow-Up

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CIS with or without Papillary:

  • Oral presentation from QUILT-3.032 study showed 71% complete response rate (N=100), with duration of response ranging up to more than 53 months, in BCG-unresponsive NMIBC CIS with or without papillary disease
  • Probability of duration of complete response of at least 45 months in the FDA label population (N=77) is 51%, with median duration of complete response of 45.4 months
  • Cystectomy avoidance rate in responders of 84% at 36 months
  • Disease-specific overall survival rate of 99% at 36 months
  • Longest follow-up of BCG-unresponsive CIS patients with unmatched more than 5 years data available (as of July 2024 data cutoff)
Papillary without CIS:

  • Disease-free survival rate of 58% at 12 months (primary endpoint) and 52% at 24 months
  • Cystectomy avoidance rate of 82% at 36 months—unmatched by any product in the field to date
  • Disease-specific overall survival rate of 96% at 36 months
  • Supplemental BLA submitted for FDA approval for this indication
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