ImmunityBio announces resubmissionof N-803 or Anktiva BLA to FDA

ImmunityBio announced it has completed the resubmission of its Biologics License Application BLA to the U.S. Food and Drug Administration FDA for N-803 Anktiva , a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guerin BCG for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease. The BLA is supported by the results of ImmunityBio’s studies in bladder cancer including the pivotal QUILT-3.032 study published in NEJM Evidence1 in November 2022. An update of the duration of response regarding the responders identified by the FDA in the efficacy population for BCG unresponsive subjects with high-risk CIS disease was provided in the BLA resubmission. This update demonstrated a prolonged duration of remission in responding subjects, with a median duration of CR not yet reached with a follow-up in responders exceeding 28 months, and a safety profile as reported previously. The updated duration of CR in these responding BCG-unresponsive subjects showed that the probability of maintaining a CR for = 24 months was 60%, with a cystectomy free rate at = 24 months of over 90%. I Of the 6 subjects available for follow-up 6 out of 6 subjects demonstrated long-term complete remission with bladder preservation over a median survival period of 8.8 years and all 6 subjects have avoided a cystectomy to date.