Pasadena, Calif. — January 23, 2026 — Leads & Copy — ImmunityBio, Inc. (NASDAQ: IBRX) announced updated Phase 2 clinical results from QUILT 3.078 (NCT06061809) on Thursday. The study is evaluating a chemotherapy-free combination immunotherapy regimen in patients with second-line recurrent or progressive glioblastoma (GBM), as well as patients treated under single-patient INDs (spINDs) across first- to third-line disease.
As of January 22, 2026, the study has enrolled 23 patients with recurrent or progressive GBM who progressed following standard-of-care therapy, including surgery, radiation, and temozolomide-based chemotherapy. Nineteen of the 23 enrolled patients remain alive, with four deaths reported to date.
Of the 23 enrolled patients, 14 currently have evaluable clinical data and comprise the efficacy population for the current analysis. Among these evaluable patients, a total of 139 doses of combination immunotherapy have been administered. The median follow up is 6 months in the evaluable cohort. All four deaths to date occurred within the evaluable cohort, and median overall survival has not yet been reached.
The patients enrolled in this study represent a particularly challenging population, having progressed after standard therapies and with severe lymphopenia. Observing ongoing treatment durability, survival beyond historical expectations in some patients, and a manageable safety profile without chemotherapy represents a paradigm change in the treatment of patients with glioblastoma,” said Simon Khagi, M.D., MBA, Medical Director of Neuro Oncology at the Hoag Family Cancer Institute and Principal Investigator.
Updated clinical findings will be presented by Dr. Simon Khagi at the Stand Up to Cancer Glioblastoma Innovation Scientific Summit on January 31, 2026 in Pasadena, Calif., including the focus on immune agonists as a combination backbone and the ImmunityBio Bioshield regimen.
At study entry, patients demonstrated immune compromise consistent with prior standard of care, including radiation and alkylating chemotherapy. The baseline mean absolute lymphocyte count (ALC) was approximately 900 cells per µL, consistent with lymphopenia commonly observed after prior therapy in recurrent GBM.
“These Phase 2 data reflect outcomes in a second- and third-line glioblastoma population where immune collapse after standard therapy is common and options are limited. With 19 of 23 enrolled patients alive and median overall survival not yet reached, the survival profile warrants continued follow up,” said Patrick Soon Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio.
The treatment regimen has demonstrated a manageable safety profile. Three participants experienced serious adverse events suspected to be related to the experimental therapy. Importantly, no cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS) was observed.
Overall survival is the primary endpoint of QUILT-3.078. The study includes an open-label, single-arm Phase 2 portion evaluating ANKTIVA® (nogapendekin alfa inbakicept) in combination with PD-L1 t-haNK, bevacizumab, and Tumor Treating Fields in patients with recurrent glioblastoma.
The program also includes a randomized Phase 2B component designed to further evaluate durability of benefit. In Phase 2B, patients are randomized 1:1 to receive ANKTIVA, bevacizumab, and Tumor Treating Fields, either with or without PD-L1 t-haNK. Per protocol, study therapy is administered on an every-two-week dosing schedule within protocol-defined treatment periods. A Phase 2B expansion cohort is currently enrolling, with a target enrollment of 20 patients. To date, 8 patients have been enrolled in the Phase 2B cohort.
In parallel with the clinical trial program, 18 patients with recurrent GBM have initiated treatment under a single patient IND, of which seven patients are first line.
Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor in adults. Despite maximal multimodal therapy consisting of surgical resection, radiation, and temozolomide-based chemotherapy, outcomes remain poor. Median overall survival following initial diagnosis is approximately 14–16 months, and in the recurrent setting, median survival is typically ranges from 6 to 9 months. Five-year survival rates remain below 10 percent, underscoring the limited impact of existing therapeutic approaches.
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy.
Source: ImmunityBio
