On August 26, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported early findings from the first five recurrent glioblastoma patients treated with its investigational immune-boosting regimen including ANKTIVA (nogapendekin alfa inbakicept-pmln) in this pilot study (NCT06061809) (Press release, ImmunityBio, AUG 26, 2025, View Source [SID1234655480]). All five patients achieved 100% disease control with the regimen that combines ANKTIVA, an IL-15 agonist being studied for its ability to enhance natural killer (NK) cell activity, NK cell therapy (PD-L1 t-haNK), and Optune Gio Tumor Treating Fields. Of the 5 patients treated to date, 3 responded of which 2 at near complete response and the remaining 2 having stable disease to date. This finding of 5 out of 5 (100%) disease control in 2nd line recurrent glioblastoma receiving a chemotherapy free immunotherapy with Optune immune stimulating device is highly encouraging.
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We believe these early results of this combination immune-stimulating therapy are notable, given both the fact that GBM is a common form of brain tumor, as well as one that is exceptionally difficult to treat successfully with currently approved therapies. GBM has a single digit five-year survival rate for patients aged 45 and over. While the initial treatments in this trial involve a small cohort, the results are sufficiently encouraging for the company to plan a Phase 2 trial in second-line glioblastoma to further evaluate the potential for this combination treatment.
"GBM is a devastating type of brain cancer for which there are currently no durable treatment options, which is why this study has such important potential," said Dr. Simon Khagi, Medical Director of Neuro-Oncology at the Hoag Family Cancer Institute, and the Principal Investigator for this study. "In my years of treating patients with glioblastoma I have never experienced these near complete responses as well as the rapidity of the response as seen in these patients to date," he further stated. "There has been little advance in therapy for decades for glioblastoma. This chemotherapy free, immune-stimulating combination approach with ANKTIVA is highly promising and may represent a fundamental advance in therapy in patients with tumors of the brain."
"Although they are early, these results are very encouraging, given the high risk and low survival rates associated with GBM," added Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "There is compelling evidence that ANKTIVA’s mechanism of proliferating NK and T cells plays an important role in treating patients with cancer Independent of tumor type. By activating the immune system the goal of providing durable responses is at hand. We believe these preliminary results in patients with GBM, whose lymphocyte counts (NK and T cells) are low as a consequence of radiation and chemotherapy after first-line treatment, can be rescued following ANKTIVA and NK cell therapy, and warrant the rapid expansion of this study in recurrent glioblastoma."
To learn more about this glioblastoma trial visit clinicaltrials.gov/study/NCT06061809 and cssifm.org
ANKTIVA, which is approved by the U.S. Food and Drug Administration with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, is being evaluated alone and with other agents in multiple studies for non-small cell lung cancer, non-Hodgkin lymphoma, Lynch syndrome (hereditary colon cancer), ovarian cancer and Human Papillomavirus (HPV) associated tumors. ANKTIVA is also being studied in Human Immunodeficiency Virus (HIV) and lymphopenia.
To learn more about ImmunityBio’s clinical trials, visit immunitybio.com/find-a-trial/ and cssifm.org.
Optune Gio is a registered trademark of Novocure GmbH.
About ANKTIVA (nogapendekin alfa inbakicept-pmln)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.
DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.
Please see the complete Prescribing Information for ANKTIVA at Anktiva.com.