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ImmunityBio Announces ANKTIVA® Plus BCG Meets Primary Endpoint in BCG-Naïve Non-Muscle Invasive Bladder Cancer Randomized QUILT-2.005 Trial

IBRX
  • ImmunityBio announced that ANKTIVA plus BCG met the primary efficacy endpoint in the QUILT-2.005 registrational trial involving 370 BCG-naïve NMIBC patients.
  • The chemotherapy-free combination demonstrated a statistically significant improvement in response rates for patients with carcinoma in situ, with or without papillary tumors.
  • Treatment-emergent adverse events were consistent with BCG alone, & no treatment-related deaths were reported.
  • Patient-reported quality of life was maintained, & the median duration of response had not yet been reached.
  • A supplemental Biologics License Application (sBLA) is on track for submission to the FDA by year-end 2026 to expand the indication to BCG-naïve patients.
  • The trial was conducted across over 75 sites, with the largest enrollments at US Urology Partners, Dartmouth-Hitchcock, & the University of California Los Angeles.
  • Database lock occurred on October 20, 2026, following enrollment completion in February 2026.
  • ANKTIVA is an IL-15 receptor agonist that activates NK cells & memory T cells to prolong the duration of response.
  • The current ANKTIVA indication remains for BCG-unresponsive NMIBC, with the proposed expansion targeting patients earlier in their disease course.
  • Additional study details will be presented at an upcoming medical congress.