-+ 0.00%
-+ 0.00%
-+ 0.00%

ImmunityBio Anticipates Reporting Topline Results In November 2026, Remains On Track To Submit sBLA To FDA In Q4 2026 For ANKTIVA Plus BCG In Patients With BCG-Naïve NMIBC

Benzinga·10/21/2026 11:38:46
Listen to the news
  • Database lock completed for Cohort A of QUILT-2.005 (NCT02138734), a randomized, controlled registrational trial comparing ANKTIVA® plus BCG with BCG alone in 366 patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC)
  • ANKTIVA plus BCG is being evaluated as the first locally delivered, chemotherapy-free combination immunotherapy for BCG-naïve NMIBC
  • Final analysis of the trial’s primary efficacy endpoint is underway, with topline results expected in November 2026
  • Supplemental Biologics License Application (sBLA) submission remains on track for the fourth quarter of 2026, potentially expanding ANKTIVA’s indication to include patients with BCG-naïve NMIBC earlier in their disease course