Glioblastoma treatment combo shows promise in pilot study
All 5 participants respond to treatment in developer-sponsored trial
A combination therapy for glioblastoma showed encouraging early results, with all five patients treated in a pilot study responding to it.
Based on the data, developer Immunitybio plans to launch a Phase 2 clinical trial to evaluate nogapendekin alfa inbakicept-pmln in combination with the Optune Gio device to further evaluate the safety and efficacy of nogapendekin in people with glioblastoma that has failed to respond to first-line treatment.
“Although they are early, these results are very encouraging, given the high risk and low survival rates associated with [glioblastoma],” Patrick Soon-Shiong, MD, founder, executive chairman, and global chief scientific and medical officer at Immunitybio, said in a company press release.
Glioblastoma (GBM) is an aggressive form of glioma mainly affecting older adults. Available treatments have limited efficacy: Five-year survival rates for patients older than 45 with GBM are lower than 10%.
“GBM is a devastating type of brain cancer for which there are currently no durable treatment options, which is why this study has such important potential,” said Simon Khagi, MD, medical director of neuro-oncology at Hoag Family Cancer Institute and the pilot study’s principal investigator.
‘I have never experienced these near complete responses:’ Researcher
Nogapendekin is designed to mimic the activity of interleukin-15 (IL-15), a signaling molecule that promotes the activation of natural killer (NK) cells. As their name suggests, these cells are immune cells that can naturally kill other cells, including cancer cells. Nogapendekin aims to activate NK cells and other immune cells like T-cells to attack and kill tumor cells more effectively.
The therapy is approved in the U.S. to treat some forms of bladder cancer, and is marketed under the brand name Anktiva. Immunitybio is investigating its therapeutic potential in other cancer types.
“There is compelling evidence that [nogapendekin]’s mechanism of proliferating NK and T cells plays an important role in treating patients with cancer Independent of tumor type. By activating the immune system the goal of providing durable responses is at hand,” Soon-Shiong said.
In the pilot study (NCT06061809), five people with GBM were treated with nogapendekin in combination with Optune Gio, a wearable device approved to treat GBM that works by generating electrical fields to slow cancer cell growth.
Immunitybio said three patients saw their tumors shrink, with two patients’ tumors almost entirely disappearing. The remaining two patients’ tumors did not shrink, but they didn’t grow either, meaning these patients had stable disease.
“In my years of treating patients with glioblastoma I have never experienced these near complete responses as well as the rapidity of the response as seen in these patients to date,” Khagi said.
All five patients had previously received chemotherapy and radiation therapy. A common side effect of these treatments is a reduction in the number of lymphocytes — a group of immune cells that includes NK and T-cells. In all five, treatment with nogapendekin was followed by an increase in lymphocyte counts.
“We believe these preliminary results in patients with GBM, whose lymphocyte counts (NK and T cells) are low as a consequence of radiation and chemotherapy after first-line treatment, can be rescued following [nogapendekin] and NK cell therapy, and warrant the rapid expansion of this study in recurrent glioblastoma,” Soon-Shiong said.
Khagi said the data suggest that this type of treatment “is highly promising and may represent a fundamental advance in therapy in patients with tumors of the brain.”
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