The Promise of Anktiva: Expert Insight on IL-15 Therapy in Cancer Care
Key Points
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Anktiva (N-803) is an interleukin (IL)-15 receptor superagonist designed to expand and activate natural killer (NK) cells and CD8 memory T cells without stimulating regulatory T cells (Tregs).
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In Bacillus Calmette-Guérin (BCG)-unresponsive non–muscle invasive bladder cancer (NMIBC), Anktiva demonstrated a 71% complete response rate with durable responses.
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Combination therapy showed significant overall survival (OS) improvement in later-line non–small cell lung cancer (NSCLC), especially in patients whose absolute lymphocyte count (ALC) was restored.
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Early signals in glioblastoma, triple-negative breast, and prostate cancers suggest a potential platform across tumors.
Patrick Soon-Shiong, MD, a pioneering surgical oncologist and the developer of nab-paclitaxel, joined the Oncology Brothers, Rahul Gosain, MD, MBA, of Wilmot Cancer Institute, and Rohit Gosain, MD, of Roswell Park Comprehensive Cancer Center, to discuss his latest immunotherapy platform, Anktiva (N-803).
Dr. Soon-Shiong, the founder of ImmunityBio, explained the science behind IL-15–based immune activation, clinical data supporting its use, and its potential to reshape cancer treatment across tumor types.
Stimulating IL-15
Anktiva is an IL-15 receptor superagonist designed to expand and activate NK cells and CD8 memory T cells. Unlike IL-2, which stimulates both effector T cells and immunosuppressive Tregs, IL-15 drives expansion of cytotoxic lymphocytes without significantly expanding Tregs, he explained.
Administered subcutaneously, IL-15–based therapy aims to actively rebuild immune capacity by expanding the number and function of NK cells and CD8 T cells. Dr. Soon-Shiong emphasized that many patients with advanced cancer experience treatment-related lymphopenia from chemotherapy or radiation, leaving them immunologically depleted. Restoring immune competence, particularly ALC, may be critical for durable responses, he said.
Anktiva Clinical Trial Data
Anktiva is FDA-approved in the United States for use in adults with BCG-unresponsive NMIBC with carcinoma in situ. Clinical trial data demonstrated a 71% complete response rate, with some responses durable for more than 47 months. Notably, cystectomy rates were low, and Dr. Soon-Shiong stressed the importance of ALC as a biomarker in these patients, with patients whose post-treatment ALC exceeded approximately 1,000–1,200 cells/µL experiencing better outcomes.
A randomized study in previously treated advanced NSCLC showed that Anktiva plus a checkpoint inhibitor, compared with checkpoint inhibitor alone, led to a longer median OS (25 months vs 8 months).
Beyond bladder and lung cancer, Dr. Soon-Shiong described signals of activity in glioblastoma, triple-negative breast cancer, and prostate cancer. “We have, within our body, the power within us to stimulate the very cells that kill cancer with a simple subcutaneous injection,” Dr. Soon-Shiong said.
Clinical Implications
Future directions include subcutaneous outpatient administration, combination strategies with chimeric antigen receptor T-cell therapies, and the potential use of apheresis to expand autologous NK cells.
Safety was favorable, with most adverse events limited to mild injection site reactions and low-grade fever that resolved within 2 to 3 days.
“We’re giving you a cytokine that your body manufactures. We’re activating what your body does in times of infection, at times of cancer, and believe it or not even for immunosenescence for longevity,” Dr. Soon-Shiong said.