Express 57% of bladder cancer patients have no recurrence in 12 months, and IL-15 super agonist reaches phase 2/3 clinical endpoint

▎ WuXi AppTec content team editor October 19, 2021, ImmunityBio announced that its IL-15 super agonist complex Anktiva (N-803) and BCG vaccine (BCG) combined with In the phase 2/3 clinical trial of NMIBC, the primary end point for the treatment of patients with papilloma subtypes was reached, and 57% of patients reached 12-month disease-free survival (DFS)
.

Previously, Anktiva achieved a 72% complete remission rate in the treatment of patients with carcinoma in situ (CIS) subtypes
.

 Bladder cancer is a cancer type with a high incidence worldwide.
In 2020, there will be more than 570,000 newly confirmed cases and more than 200,000 deaths
.

About 90% of non-muscular invasive bladder cancer (NMIBC) cases are papilloma
.

Over the past 30 years, bladder perfusion BCG has been the standard treatment for patients with non-invasive papilloma, but about 40% of them did not respond to treatment
.

The cytokine interleukin-15 (IL-15) plays a vital role in the immune system by affecting the development, maintenance and function of natural killer (NK) cells and immune T cells
.

Anktiva consists of IL-15 mutant (IL-15N72D) that binds to IL-15 receptor α/IgG1 Fc fusion protein
.

It binds to βγ T cell receptors, directly and specifically stimulates CD8 positive T cells and NK cells, while avoiding stimulation of regulatory T cells (Treg)
.

Compared with natural, non-complex IL-15, Anktiva has better pharmacokinetic properties in patients, and can exist in the lymphatic tissue for a longer time, showing enhanced anti-tumor activity
.

In December 2019, the US FDA granted Anktiva breakthrough therapy designation
.

▲Anktiva's mechanism of action (picture source: reference [2]) At a median follow-up time of 17.
3 months, according to Kaplan-Meier analysis, the proportion of patients with DFS at 12 months was 57% (95% CI: 43.
7%) , 68.
5%), 53% at 18 months (95% CI: 38.
8%, 64.
6%)
.

Anktiva observed sustained responses in both papilloma and carcinoma in situ patient cohorts (n=154), and 85% of patients were able to avoid cystectomy
.

Dr.
Patrick Soon-Shiong, Founder and Global Chief Scientific Officer and Medical Officer of ImmunityBio, said: “Anktiva has already demonstrated strong disease control capabilities in patients with carcinoma in situ.
Based on the latest data from our research, it is also effective in patients with papilloma.
Show the same effect
.

We are confident in the potential of this combination therapy to benefit NMIBC patients who do not respond to BCG treatment
.

"Reference: [1] ImmunityBio Announces Primary Endpoint Met in a Second Indication in Bladder Cancer Trial with 57% Disease-Free Survival in Patients with BCG Unresponsive Papillary Disease.
Retrieved October 19, 2021, from https:// com/news/home/20211019005500/en[2] 39th Annual JP Morgan Healthcare Conference.
Retrieved February 16, 2021, from https://immunitybio.
com/wp-content/uploads/2021/02/2021.
01.
13-JP- Morgan-Presentation-2021-v6sm-Final-1.
pdf Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.

This article is for information exchange purposes only.
The views in the article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec supports or opposes the views
in the
article .
This article is not a recommendation for a treatment plan
.

If you need guidance on a treatment plan, please go to a regular hospital for treatment
.