Immunotherapy Combination Extends Survival in Glioblastoma Patients to Over 22 Months

Immunotherapy Extends Survival in Newly Diagnosed Glioblastoma

GC Cell Corporation's Immuncell-LC, an activated T lymphocyte immunotherapy, demonstrated improved survival outcomes when combined with temozolomide in newly diagnosed glioblastoma patients, according to results from a Phase 3 clinical trial conducted in South Korea. The study showed a median overall survival of 22.47 months in patients receiving the combination therapy compared to 16.88 months in the control group receiving temozolomide alone.

How Was the Phase 3 Trial Designed?

The multi-center, randomized, open-label trial enrolled 180 patients across seven institutes in South Korea between December 2008 and October 2012. Patients were randomized to receive either standard treatment with temozolomide chemotherapy and radiation therapy, or the same standard treatment plus Immuncell-LC, administered 14 times intravenously. The study population had a median age of 54.5 years, with baseline characteristics well-balanced between groups.

The primary endpoint of progression-free survival showed a median of 8.1 months in the immunotherapy group versus 5.4 months in the control group. Disease progression was assessed locally by investigators using enhanced MRI performed approximately four weeks after chemoradiotherapy, then at regular intervals through 46 weeks after randomization, and every three to twelve months thereafter during follow-up.

What Are Activated T Lymphocytes and How Do They Work?

Immuncell-LC consists of activated T lymphocytes, specifically cytokine-induced killer cells, manufactured from each patient's blood drawn at least two weeks before administration. For a 60-kilogram adult, the treatment delivers 100 milligrams containing between one billion and 20 billion lymphocytes administered intravenously over one hour. The therapy is designed for removal of minimal residual cancer after brain tumor surgery and relapse prevention.

Safety Profile Comparable to Standard Treatment

Safety profiles between the treatment groups appeared comparable. In the control group, 52 deaths occurred among 89 patients, while 51 deaths occurred among 91 patients in the immunotherapy group. Serious adverse events affected 31 patients in the control group and 35 in the immunotherapy group. The most common adverse events in both groups included nausea, decreased appetite, alopecia, and neurological symptoms consistent with the underlying disease and standard glioblastoma treatment.

Glioblastoma remains one of the most aggressive primary brain tumors with limited treatment options. The standard of care involves surgical resection followed by radiation therapy and temozolomide chemotherapy. The trial evaluated whether adding immunotherapy to this regimen could improve outcomes in this difficult-to-treat patient population.

The study was sponsored by GC Cell Corporation, with Chunghyun Kim from Hanyang University serving as the principal investigator. The trial completed enrollment and follow-up in October 2012, with results becoming publicly available in October 2025 through the ClinicalTrials.gov registry under identifier NCT00807027.

Summary

A Phase 3 clinical trial conducted in South Korea has demonstrated that GC Cell Corporation's Immuncell-LC, an activated T lymphocyte immunotherapy, significantly improved survival outcomes in newly diagnosed glioblastoma patients when added to standard temozolomide chemotherapy. The multi-center, randomized trial enrolled 180 patients across seven South Korean institutes between 2008 and 2012. Results showed median overall survival of 22.47 months in patients receiving the combination therapy compared to 16.88 months with temozolomide alone. Progression-free survival also improved, reaching 8.1 months versus 5.4 months in the control group. Immuncell-LC consists of cytokine-induced killer cells manufactured from each patient's blood and administered intravenously 14 times alongside standard treatment. The safety profile appeared comparable between groups, with adverse events consistent with the underlying disease and standard glioblastoma treatment. The therapy targets minimal residual cancer after surgical resection and aims to prevent relapse in this aggressive brain tumor with limited treatment options.