BLA resubmission for N 803 in BCG-unresponsive non-muscle-invasive bladder cancer carcinoma-in-situ
ImmunityBio, Inc. a clinical-stage immunotherapy company, announced it has completed the resubmission of its Biologics License Application (BLA) to the FDA for N 803 (Anktiva), a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) 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 (NCT03022825), published in NEJM Evidence 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 greater than 24 months was 60%, with a cystectomy free rate at greater than 24 months of over 90%.
In addition, ImmunityBio provided an update on the long-term follow-up (QUILT-205) of subjects receiving N 803 plus BCG for CIS ± Ta/T1 in the Phase 1b (QUILT-2.005) trial, examining the survival of the nine subjects entering the trial since 2014. All 9 subjects (100%) achieved a complete remission and the results are published in Oncoimmunology. Of the nine subjects, two were deceased from causes other than bladder cancer and one was lost to follow-up. Of the 6 subjects available for follow-up (QUILT-205), 6 out of 6 subjects (100%) 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.
See- Chamie, K., Chang, S. S., Kramolowsky, E., Gonzalgo, M. L., Agarwal, P. et al.," IL-15 Superagonist NAI in BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer". In NEJM Evidence (Vol. 2, Issue 1). Massachusetts Medical Society.https://doi.org/10.1056/evidoa2200167.
See-Rosser CJ, Tikhonenkov S, Nix JW, Chan OTM, Ianculescu I, Reddy S, Soon-Shiong P.- " Safety, Tolerability, and Long-Term Clinical Outcomes of an IL-15 analogue (N 803) Admixed with Bacillus Calmette-Guérin (BCG) for the Treatment of Bladder Cancer". Oncoimmunology. 2021 May 3;10(1):1912885. doi: 10.1080/2162402X.2021.1912885. PMID: 33996264; PMCID: PMC8096327.
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