Express | Complete remission rate reached 71%, IL-15 super agonist reached phase 2/3 clinical endpoint

▎The editor of WuXi AppTec's content team announced today that its IL-15 super agonist complex Anktiva (N-803) combined with BCG vaccine (BCG) can be used in the treatment of non-muscle invasive bladder cancer that does not respond well to BCG (NMIBC) The primary endpoint was reached in the Phase 2/3 clinical phase of Carcinoma in Situ (CIS).

At a median follow-up time of 10.
7 months, 71% of the 72 evaluable patients treated with the combination therapy achieved complete remission.

Bladder cancer is a cancer type with a higher incidence worldwide.

In 2020, there will be more than 570,000 newly confirmed cases, and more than 200,000 people will die as a result.

In the past 30 years, BCG immunotherapy has been the standard treatment for NMIBC.

However, the rate of disease recurrence and progression is still high.

Among patients with recurrence of the disease, 50% of patients will undergo a complete bladder removal operation to control the condition.

Even though minimally invasive surgical techniques have made significant progress, the mortality rate of patients undergoing cystectomy within 90 days is still 5.
1%-8.
1%.

ImmunityBio's Anktiva is a potential "first-in-class" IL-15 super agonist complex.

It is formed by combining an IL-15 mutant (IL-15N72D) with a fusion protein composed of IL-15 receptor α and the Fc end of IgG1, which produces anti-cancer activity by activating natural killer cells and CD8-positive T cells.

Compared with the natural non-composite IL-15 in the body, Anktiva's pharmacokinetic properties have been improved, and it can stay in the lymph node tissue for a longer period of time and has a higher anti-cancer activity.

It has been granted a breakthrough therapy designation by the FDA and is used in combination with BCG to treat patients with non-muscle invasive bladder cancer in situ who had previously poorly responded to BCG.

▲Anktiva's mechanism of action (picture source: reference [2]) Phase 2/3 clinical trial data show that in patients with high-risk NMIBC carcinoma in situ who do not respond to BCG, the median follow-up time is 10.
7 months, Anktiva The +BCG combination therapy achieved a complete remission rate of 71%.

Currently 87.
5% of patients avoid cystectomy.

The study also predicts that the median duration of complete remission for patients is 19.
2 months, and 59% of patients receiving treatment have a possible complete remission duration of more than 12 months.

"The combination of BCG and Anktiva showed a high rate of complete remission, and no serious adverse events occurred.

Data show that this combination therapy may be a promising alternative to existing therapies.

" Research presenter, University of California, Los Angeles Said Dr.
Karim Chamie, Professor of Urology.

Note: This article is intended to introduce medical and health research, not to recommend treatment options.

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

Reference: [1] ImmunityBio Announces ASCO Genitourinary Cancer Symposium Presentation of Phase 2/3 Trial for BCG Unresponsive Non-Muscle Invasive Bladder Cancer CIS with 71% Complete Response Rate.
Retrieved February 16, 2021, from https:// .
com/news/home/20210216005447/en[2] 39th Annual JP Morgan Healthcare Conference.
Retrieved February 16, 2021, from https://immunitybio.
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13-JP -Morgan-Presentation-2021-v6sm-Final-1.
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