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Nogapendekin alfa inbakicept plus PD-L1 t-haNK and bevacizumab produced encouraging overall survival data in recurrent glioblastoma.
Treatment with nogapendekin alfa inbakicept (Anktiva) in combination with the natural killer (NK) cell therapy PD-L1 t-haNK and bevacizumab (Avastin) generated a median overall survival (OS) that was not reached in patients with recurrent glioblastoma, according to data from the single-arm, phase 2 QUILT-3.078 trial (NCT06061809).1
Findings announced by ImmunityBio showed that the median OS data were generated in the efficacy-evaluable population (n = 14) at a median follow-up of 6 months. In the overall population (n = 23), 19 patients were alive at data cutoff; the 4 patient deaths all occurred in the efficacy-evaluable population.
Detailed findings from the study will be presented at the Stand Up to Cancer Glioblastoma Innovation Scientific Summit on January 31, 2026.
“Across contemporary studies, median OS for patients with recurrent glioblastoma is approximately 6 to 9 months. Outcomes beyond this benchmark remain uncommon, underscoring the substantial unmet medical need in this disease,” Simon Khagi, MD, MBA, medical director of Neuro Oncology at the Hoag Family Cancer Institute and principal investigator of QUILT-3.078, stated in a news release. “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.”
The phase 2 trial is comprised of 2 parts: a single-arm, open-label study evaluating nogapendekin alfa inbakicept plus PD-L1 t-haNK, and bevacizumab; as well as a phase 2b open-label, randomized portion evaluating nogapendekin alfa inbakicept plus bevacizumab and tumor treating fields with or without PD-L1 t-haNK.2
The single-arm portion of the study is enrolling patients at least 18 years of age with histologically confirmed glioblastoma per 2021 WHO Classification of Tumors of the Central Nervous System (WHO CNS5) criteria who had progressive or recurrent disease per RANO criteria within 3 weeks of receiving study treatment. Other key inclusion criteria comprise prior first-line therapy with at least radiotherapy and temozolomide (Temodar), a life expectancy of more than 12 weeks, and a Karnofsky performance status of at least 70.
In the single-arm portion, patients are receiving subcutaneous nogapendekin alfa inbakicept at 1 mg, intravenous (IV) PD-L1 t-haNK at ~2 x 109 cells/infusion, and IV bevacizumab at 10 mg/kg, each given on days 1 and 15 of each cycle. Treatment lasts for a maximum of 76 weeks or 19 cycles.
The primary end points of the study are safety; incidence of clinically significant changes in comprehensive metabolic panel, hematology blood panel, urinalysis, temperature, heart rate, respiratory rate, blood pressure, and oxygen saturation; 12-lead ECG outcomes; and incidence of immune effector cell–associated neurotoxicity syndrome (ICANS).
The regimen is also being evaluated in a single-patient investigational new drug program across first- to third-line settings; in this population, 7 patients being treated in the first line were still alive as of data cutoff.1
Safety data showed that the combination regimen displayed a manageable safety profile, with no instances of cytokine release syndrome (CRS) or ICANS reported.
Data also showed that immune compromise was consistent with standard-of-care therapies such as radiation and alkylating chemotherapy. Patients had a baseline mean absolute lymphocyte count (ALC) of 0.9 x 103/uL, indicating severe lymphopenia. After 1 treatment cycle (n = 14), the mean ALC increased to at least 1.4 x 103/µL (P < .001). Statistically significant increases from baseline ALC were observed through 20 weeks (P ≤ .026).
