ImmunityBio's IL-15 Superagonist Anktiva Achieves 71% Complete Response Rate in Phase 2/3 Trial for BCG-Unresponsive NMIBC

ImmunityBio Announces That Its IL-15 Superagonist Complex Anktiva (N-803) in Combination with Bacillus Calmette-Guérin (BCG) Met the Primary Endpoint in a Phase 2/3 Clinical Trial for Carcinoma In Situ (CIS) of Non-Muscle-Invasive Bladder Cancer (NMIBC) in Patients with BCG-Unresponsive Disease. At a Median Follow-Up of 10.7 Months, 71% of the 72 Evaluable Patients Treated with the Combination Therapy Achieved Complete Response.

Bladder cancer is one of the most commonly diagnosed cancers worldwide. In 2020, there were over 570,000 new cases and more than 200,000 deaths attributed to this disease. Over the past three decades, Bacillus Calmette-Guérin (BCG) immunotherapy has remained the standard of care for non-muscle-invasive bladder cancer (NMIBC). However, rates of disease recurrence and progression remain high. Among patients who experience recurrence, 50% undergo radical cystectomy to control the disease. Despite significant advances in minimally invasive surgical techniques, the 90-day mortality rate following radical cystectomy remains between 5.1% and 8.1%.

ImmunityBio’s Anktiva is a potential “first-in-class” IL-15 superagonist complex. It consists of an IL-15 mutant (IL-15N72D) bound to a fusion protein comprising the IL-15 receptor alpha and the Fc domain of IgG1, exerting anticancer activity by activating natural killer cells and CD8-positive T cells.

Compared with endogenous, non-complexed IL-15, Anktiva exhibits improved pharmacokinetic properties, enabling prolonged retention in lymph node tissues and demonstrating enhanced anticancer activity. It has previously received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for use in combination with BCG for the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ.

Data from Phase 2/3 clinical trials demonstrated that in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ, the Anktiva plus BCG combination therapy achieved a complete response rate of 71% at a median follow-up of 10.7 months. Currently, 87.5% of patients have avoided cystectomy. The study also projected a median duration of complete response of 19.2 months, with 59% of treated patients likely to maintain complete response for more than 12 months.

“The combination of BCG and Anktiva demonstrated a high complete response rate, with no serious adverse events reported. The data suggest that this combination therapy may be a promising alternative to existing treatments,” said study presenter Dr. Karim Chamie, Professor of Urology at the University of California, Los Angeles.

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at a reputable hospital.

References:

[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://www.businesswire.com/news/home/20210216005447/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

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