ImmunityBio’s immunotherapy combination regimen has demonstrated its early potential during a mid-stage trial in patients with glioblastoma and severe lymphopenia.
The regimen being put to the test in the Phase II QUILT-3.078 study (NCT06061809) combines the activity of ImmunityBio’s interleukin-15 (IL-15) agonist Anktiva (nogapendekin alfa) and its engineered programmed death ligand 1 (PD-L1)-targeting natural killer (NK) cell therapy PD-L1 t-haNK, Genentech’s monoclonal antibody (mAb) Avastin (bevacizumab), and tumour treating fields.
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As of 22 January, 19 of the 23 patients who have received the combination in the open-label, single-arm Phase II trial remain alive, with the primary endpoint of median overall survival (OS) not yet being reached. Four deaths occurred in the evaluable cohort of 14 patients. The longest survival from the time of disease recurrence has reached 12 months and is ongoing.
Patients treated with the combination also experienced the recovery and maintenance of lymphocyte counts without chemotherapy. This is significant as patients with recurrent glioblastoma often experience lymphopenia – a condition often driven by treatment with standard of care (SoC) options like radiotherapy and temozolomide-based chemotherapy.
These treatment impacts were observed in glioblastoma patients demonstrating severe lymphopenia who had previously progressed after first-line treatment.
Alongside early signals of efficacy, the combination regimen also exhibited a manageable safety profile. Three of 41 patients, 23 from the QUILT-3.078 study and 18 single-patient investigational new drug (IND) administrations, have experienced serious treatment-emergent adverse events (TEAEs) thus far. There have been no incidences of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS) to date.
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By GlobalDataUpdated results from the trial will be presented at the Stand Up to Cancer Glioblastoma Innovation Scientific Summit in Pasadena, California on 31 January 2026.
Shifting treatment paradigms in glioblastoma
While the wider oncology field is in an era of rapid progress, certain solid tumours remain stubbornly hard to treat, including glioblastoma which has a five-year survival rate of just 6.8%, according to the National Brain Tumour Society.
Meanwhile, contemporary studies reveal that the median OS rate for patients with glioblastoma is around six to nine months – signalling a significant unmet need for patients.
According to Patrick Soon Shiong, ImmunityBio’s chief scientific and medical officer, the survival rates observed to date in the QUILT-3.078 study “warrant continued follow-up” due to the chemotherapy-free combination’s ability to allow the recovery and maintenance of lymphocyte counts.
Soon Shiong also highlighted the near complete response of patients, with “survival extending beyond 12 months from the time of documented disease progression”., which he said is rare in recurrent glioblastoma.
There are currently several drugs in development for glioblastoma, with key targets like vascular endothelial growth factor (VEGF), programmed cell death protein 1 (PD-1) and epidermal growth factor receptor (EGFR) taking centre stage.
