Dr. Soon-Shiong highlights efforts to increase access to 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 efforts to increase accessibility to the therapy across the US, which was also addressed at the 2024 American Urological Association Annual Meeting in San Antonio, Texas. Soon-Shiong is the executive chairman and global chief scientific and medical officer for ImmunityBio, Inc, the developer of N-803.

Video Transcript:

It is very clear, however, that BCG is a very important component of any immunostimulant. We can talk a little bit more about the issue of chronic shortages of BCG, which we have also addressed at this conference. We’ve addressed the chronic shortage of BCG by announcing that we've made a partnership with the Serum Institute of India, that generates and manufactures huge amounts of large-scale BCG for the world. But more excitingly, they also have recombinant BCG, which has completed phase 1/2 trials in Europe, which they say is safer. More importantly, it is even more immunogenic. We will be testing that BCG as well.

Then finally, we talked about our Patient Assistance Program, which we recognize we want to have this drug accessible to all. So, we've launched a hub called anktiva.com. If anybody wants to understand how to access that, just type in anktiva.com, because what we've said is that patients that are eligible, they have to go through the eligibility, the copay will be limited to $100 for the drug. But more importantly, there are patients who have no insurance, there are patients who have no other resources and are maybe even on the poverty line. We feel, importantly, that we have an obligation that the drug be made free for these patients in the United States. Again, that's at anktiva.com, in which both the physician and the back office can find the eligibility. We've created a service that can walk the office through to get access not only to the drug, but to this knowledge of the Patient Assistance Program.

Then there's one final comment I'd like to make. I think the importance of this drug is that we have not changed the workflow of BCG. The ordering of the BCG is the same, but more importantly, the dose administration, there's no retraining of the nursing staff, the technical staff; it is merely taking exactly what you do with BCG and hand mixing the Anktiva. Since Anktiva doesn't require any freezing, it's just in the fridge, it could be pulled out of the fridge and mixed without any special differences on how you manage BCG. It has a 24-month shelf life. So, if the patient happens not to show up, you've not lost the molecule at all. These are really important, small but big issues that we recognize that we do not want to change the urology practice or their workflow whatsoever.

This transcription has been edited for clarity.