The majority of patients with recurrent glioblastoma remain alive following treatment with an experimental immune-modulating combination, according to a clinical trial update from Immunitybio. The data highlights a potential shift in managing a disease where “immune collapse” is common and survival typically drops sharply after standard therapies fail.
The Phase 2 QUILT 3.078 study (NCT06061809) has so far enrolled 23 patients whose cancer progressed despite standard treatments like surgery, radiation, and chemotherapy. These patients received a combination therapy including Anktiva (nogapendekin alfa inbakicept), a drug that is designed to increase the activity of cancer-killing immune cells. The therapy is approved in the U.S. for some forms of bladder cancer, with the company investigating its therapeutic potential for other cancer types.
“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, MD, founder, executive chairman and global chief scientific and medical officer of ImmunityBio. He added that these results are particularly notable given the limited options available for second- and third-line glioblastoma patients.
Surpassing historical survival benchmarks
Immunitybio reports that, of the 23 patients, 19 are alive as of the latest follow-up. Clinical data are available from 14 patients — the four who have died, and 10 who are still alive. The median follow-up time in the evaluable cohort is six months.
“Across contemporary studies, median overall survival for patients with recurrent glioblastoma is approximately six to nine months,” said Simon Khagi, MD, principal investigator of the trial at the Hoag Family Cancer Institute. “Outcomes beyond this benchmark remain uncommon, underscoring the substantial unmet medical need in this disease.”
Cancer treatments like radiation and chemotherapy commonly lead to low levels of infection-fighting immune cells called lymphocytes, a condition known as lymphopenia. Consistent with this, patients enrolled in the Phase 2 study generally had low lymphocyte counts at the start of the study. Among the 14 with clinical data available, the average was 900 cells per microliter of blood. Within one cycle of the combination treatment, lymphocyte counts in these patients increased to an average of 1,400 cells/microliter, a level maintained over months of follow-up.
“The patients that entered this study all suffered profound lymphopenia … consistent with prior radiation and chemotherapy exposure,” Shiong said. “On treatment, we observed recovery and maintenance of lymphocyte counts without chemotherapy.”
Across this Phase 2 study and single-patient programs, a total of 41 patients have been treated with the combination immunotherapy. The therapy has so far shown a “manageable safety profile,” Immunitybio reports. Three serious treatment-related side effects have been reported; no further details were provided.
“The patients enrolled in this study represent a particularly challenging population, having progressed after standard therapies and with severe lymphopenia,” Khagi said. “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 study includes an open-label arm testing Anktiva in combination with PD-L1 t-haNK, bevacizumab, and Tumor Treating Fields. Like Anktiva, PD-L1 t-haNK aims to stimulate immune cells to attack cancer cells. Meanwhile, bevacizumab (sold as Avastin, among others) is an approved glioblastoma treatment designed to block the growth of blood vessels in tumors, and Tumor Treating Fields is a technology that uses electrical fields to slow tumor growth.
The clinical trial also includes a Phase 2B arm in which patients will receive Anktiva, bevacizumab, and Tumor Treating Fields, with or without PD-L1 t-haNK. The study’s main goal is to evaluate the impact of these treatments on overall survival.
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