ImmunityBio Announces Biological License Application Resubmission for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma-In-Situ - Seite 2

N-803 is currently being evaluated in adult patients in two clinical NMIBC trials. QUILT-2.005 is investigating use of N-803 in combination with BCG for patients with BCG-naïve NMIBC; QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC CIS and Papillary Disease.

N-803 is investigational. Safety and efficacy have not been established by any Health Authority or Agency, including the FDA.

Selected Publications:

1. Chamie, K., Chang, S. S., Kramolowsky, E., Gonzalgo, M. L., Agarwal, P. K., Bassett, J. C., Bjurlin, M., Cher, M. L., Clark, W., Cowan, B. E., David, R., Goldfischer, E., Guru, K., Jalkut, M. W., Kaffenberger, S. D., Kaminetsky, J., Katz, A. E., Koo, A. S., Sexton, W. J., … Soon-Shiong, P. (2023). 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
2. 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.
3. Chamie K, Chang SS, Gonzalgo M, Kramolowsky EV, Sexton WJ, Bhar P, et al.. Final clinical Results of Pivotal Trial of IL-15rαfc Superagonist N-803 with BCG in BCG-Unresponsive CIS and Papillary Non-Muscle Invasive Bladder Cancer (NMIBC). J Clin Oncol (2022) 40(16_suppl):4508. doi: 10.1200/JCO.2022.40.16_suppl.4508
4. Chamie K, Chang SS, Gonzalgo M, Kramolowsky EV, Sexton WJ, Bhar P, et al.. Phase II/III Clinical Results of IL-15rαfc Superagonist N-803 with BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma in Situ (CIS) Patients. J Clin Oncol (2021) 39(suppl 6):510. doi: 10.1200/JCO.2021.39.6_suppl.510
5. Huang J, Shiao SL, Furuya H, Rosser CJ. Immunogenomic Analysis of Exceptional Responder to ALT-803 (IL-15 Analogue) in BCG Unresponsive Nonmuscle Invasive Bladder Cancer: A Case Series and Review of the Literature. J Immunother. 2019 Nov/Dec;42(9):354-358. doi: 10.1097/CJI.0000000000000269. PMID: 31107371; PMCID: PMC6783344.

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