Dr. Soon-Shiong highlights data on N-803 in NMIBC

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 video, Patrick Soon-Shiong, MD, discusses data on N-803 that were presented at the 2024 American Urological Association Annual Meeting in San Antinio, Texas, specifically highlighting findings from the study, “QUILT-2.005: A comparison of intravesical Bacillus Calmette-Guerin (BCG) in combination with the IL-15 superagonist N-803 to BCG alone in patients with BCG-naïve NMIBC.” Soon-Shiong is the executive chairman and global chief scientific and medical officer for ImmunityBio, Inc, the developer of N-803.

Video Transcript:

Dr. [Sandeep] Reddy presented 2 sets of data. If you look at the New England Journal of Medicine article, we had what we call the planned analysis of a subset of patients. In other words, patients who had different amounts of BCG before and after treatment, patients who had chemotherapy and still failed, etc. Those subset analyses all showed that we met the primary end point and had good complete responses.¹ It's consistent with the theory that all these treatments, sadly, create this clonal selection of this cold tumor, and by reinvigorating the cold tumor to hot tumor and upregulating back the T-cells with the natural killer cells, we see the same effect regardless of the prior diseases.

We also revealed at this meeting, in fact it's coming up tomorrow, our naive data. We have a trial called QUILT 2.005, a randomized controlled trial between BCG alone vs BCG plus N-803.² The agency asked us to do an interim analysis by doing a quick look, which was interesting. The reason they needed to know that is because they want to get convinced, and they have, that the contribution of effect was not BCG, but in fact, Anktiva. We unveiled the first 43 or so patients in each arm. What was exciting, we were presenting today, complete response of 85% in the Anktiva arm compared to the BCG arm. But more excitingly, as early as 9 months, even though they were small numbers, the comparison between BCG and Anktiva vs BCG alone showed a statistical significance in the duration of ongoing complete response. I think in the naive setting, which is still ongoing in clinical trials, the consistency of this mechanism of action has now been proven.

This transcription has been edited for clarity.

References

1. Soon-Shiong P, Reddy S, Chamie K. N-803 plus BCG Complete Response rate in NMIBC CIS subjects: BCG refractory, relapsed, checkpoint failure, and chemotherapy failure; updated results (QUILT 3.032). Presented at: 2024 American Urological Association Annual Meeting. May 3-6, 2024, San Antonio, Texas. MP16-03

2. Reddy S. QUILT-2.005: A comparison of intravesical Bacillus Calmette-Guerin (BCG) in combination with the IL-15 superagonist N-803 to BCG alone in patients with BCG-naïve NMIBC. Presented at: 2024 American Urological Association Annual Meeting. May 3-6, 2024, San Antonio, Texas