Median OS Not Yet Reached With New Immunotherapy Combo in 2L Glioblastoma

Updated results from the phase 2 QUILT-3.078 trial (NCT06061809) evaluating nogapendekin alfa inbakicept-pmln (Anktiva) plus PD-L1 t-haNK, bevacizumab (Avastin), and Tumor Treating Fields in patients with second-line recurrent or progressive glioblastoma were announced in a news release from the developer, ImmunityBio.

With a data cutoff date of January 22, 2026, among 23 enrolled patients, 14 have currently available data and are included in the efficacy population. A total of 139 doses of the combination regimen have been administered.

With a median follow-up of 6 months, the median overall survival (OS) has not yet been reached. Among the 23 enrolled patients, 4 deaths have been reported to date.

Updated clinical findings will be shared at the Stand Up to Cancer Glioblastoma Innovation Scientific Summit on January 31, 2026.

In the press release, Simon Khagi, MD, MBA, medical director of Neuro Oncology at the Hoag Family Cancer Institute and principal investigator of the study, said, “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. The patients enrolled in this study represent a particularly challenging population, having progressed after standard therapies and with severe lymphopenia.”

Notably, it was also reported that patients demonstrated immune compromise consistent with prior standards of care such as radiation and alkylating chemotherapy. Of the 14 patients with available data, the baseline mean absolute lymphocyte count (ALC) was 0.9 x 10³/uL. The mean ALC increased to greater than or equal to 1.4 x 10³/uL within 1 cycle (P <.001). The increase in ALC was maintained at all assessments through 20 weeks with a statistically significant increase from baseline at ALC with nogapendekin alfa inbakicept plus CAR-NK (P ≤.026).

Patric Soon Shiong, MD, founder, executive chairman, and global chief scientific and medical officer of ImmunityBio, stated, “The patients that entered this study all [had] profound lymphopenia, reflected by a baseline mean ALC of approximately 900, consistent with prior radiation and chemotherapy exposure. On treatment, we observed recovery and maintenance of lymphocyte counts without chemotherapy.”

QUILT-3.078 is an open-label, single-arm study that enrolled patients with glioblastoma at first recurrence. The trial also enrolled 18 patients with recurrent glioblastoma who initiated treatment under a single-patient investigational new drug across first- and third-line disease. Among these 18 patients, 7 were treated in the first line and are alive to date. All enrolled patients progressed after standard-of-care therapy consisting of surgery, radiation, and temozolomide (Temodar)-based chemotherapy.

In the randomized phase 2b component of the trial, patients were randomly assigned 1:1 to receive nogapendekin alfa inbakicept, bevacizumab, and Tumor Treating Fields, with or without PD-L1 T-haNK. The treatment was administered every 2 weeks. Furthermore, a phase 2b expansion cohort is currently enrolling patients, with a target enrollment of 20. The primary end point of the trial was OS.

The regimen yielded a manageable safety profile. No cytokine release syndrome or immune-effector cell-associated neurotoxicity syndrome was observed, although 3 patients did experience serious adverse events suspected to be related to the treatment.

“Approaches that integrate immune-based therapies that maintain immune competence with direct clinical and biological observation are essential if we are to make progress. Efforts that prioritize immune competence, durability of response, and data-driven evaluation represent an important step toward redefining how glioblastoma therapies are developed and assessed,” added Joshua Bernstock, MD, PhD, clinical fellow at Harvard Medical School and neurosurgeon at Brigham and Women’s Hospital.

Reference

ImmunityBio reports median overall survival not yet reached and lymphopenia reversed in recurrent glioblastoma patients receiving ANKTIVA® plus CAR-NK, chemo-free therapy. News release. ImmunityBio. January 23, 2026. Accessed January 23, 2026. https://tinyurl.com/4a9bmjnd