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Dr. Soon-Shiong discusses the FDA approval of N-803 in NMIBC


“All this is very detailed immunology, I get that, but it sets the stage for what I consider the next evolution of immunotherapy,” says Patrick Soon-Shiong, MD.

In April 2024, the FDA approved N-803 (Anktiva, nogapendekin alfa inbakicept-pmln), a first-in-class IL-15 receptor agonist immunotherapy for use in combination with BCG for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. In this interview, Patrick Soon-Shiong, MD, discusses the significance of the FDA approval for immunotherapy in NMIBC. Soon-Shiong is the executive chairman and global chief scientific and medical officer for ImmunityBio, Inc, the developer of N-803.

Soon-Shiong also participated in a Fireside Chat with Sam S. Chang, MD, MBA, at the recent American Urological Association (AUA) Annual Meeting in San Antonio, Texas, to discuss N-803 and next-generation immunotherapy in NMIBC.

Video Transcript:

The recent FDA approval was very gratifying in the sense that while the initial issue had nothing to do with the clinical data, it had to do with the manufacturing issues of a very complicated molecule, and that delayed us. The silver lining in the delay [is that] it allowed us to continue monitoring the duration of response. As you saw in our New England Journal of Medicine article,1 the median duration was 26.6 months. Then we had this ongoing duration. By the time the FDA approved us, the results were 47 months and ongoing, which meant the median duration has yet to be determined, which is very exciting. And over 58% of patients were over 12 months. The goal of bladder-sparing or cystectomy-sparing, in my mind, has been reached from the perspective of quality-of-life, of not having your cysts, your bladder removed, and more importantly, in which the toxicities are no different than that of BCG alone. All of that is in the label, and all of that is the basis of this approval.

What we have done now, we believe, is we received a Breakthrough Designation, pleased that today with a fireside chat with Sam Chang, the recognition that this is in fact the next-generation immunotherapy beyond checkpoints, beyond T-cells, and that we've now found a way to activate natural killer cells. All of that mechanism of action is in the label. To my knowledge, this is the first label that talks about IL-15 alfa that stimulates and proliferates natural killer cells, that induces stimulation of CD4+ T-cells, CD8+ T-cells, and most importantly, memory T-cells, and then finally, without upregulating or without stimulating the immunosuppressive T regulatory cells. All this is very detailed immunology, I get that, but it sets the stage for what I consider the next evolution of immunotherapy.

This transcription has been edited for clarity.


1. Chamie K, Chang SS, Kramolowsky E, et al. IL-15 superagonist NAI in BCG-unresponsive non-muscle-invasive bladder cancer. NEJM Evid. 2023;2(1):EVIDoa2200167. doi:10.1056/EVIDoa2200167

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