SEOUL, South Korea--(BUSINESS WIRE)--The paper entitled “Phase III randomized trial of autologous cytokine-induced killer cell immunotherapy for newly diagnosed glioblastoma in Korea” was recently published in online edition of the ‘Oncotarget’, an international journal of authority in oncology.
According to the paper, cytokine-induced killer (CIK) cell-based immunotherapy made of own blood of patients with brain tumor achieved 1.5 times longer progression-free survival (PFS) and 30% increase in effect of controlling disease in these patients. This is the world’s first published data of randomized phase III clinical study of combined immunotherapy using CIK cells.
The clinical study was conducted by a team led by Prof. Kim Choong-Hyun in the Department of Neurosurgery, Hanyang University Guri Hospital, and joined by 11 investigators from 7 major hospitals, including Konkuk University Medical Center, Kyunghee University Medical Center, Korea University Anam Hospital, Samsung Medical Center, Asan Medical Center, Severance Hospital, and Hanyang University Guri Hospital.
The study conducted from December 2008 to October 2012 with a total of 180 patients with glioblastoma who met the study criteria compared the efficacy and safety by randomly assigning them into the group that received combination therapy of standard treatment and CIK cell-based immunotherapy after surgical resection (91 patients received CIK cell-based immunotherapy and ‘Immuncell-LC’ of Green Cross Cell for 14 times in 36 weeks) and the comparison group (89 patients received standard treatment after surgical resection).
Being the primary malignant brain tumor most common in adult, patients with glioblastoma survive for only 14.6 months on average despite standard therapies using surgery, temozolomide, and radiotherapy. Various combination therapies for treating glioblastoma have been introduced since a standard therapy was adopted in 2005, but they have not achieved remarkable improvement in treatment. So, the authors designed to find out whether it provides any difference in PFS by the CIK cell therapy in glioblastoma patients, which was reported to have already extended stability and relapse-free survival in patients with hepatoma.
As a result, the study demonstrated that the treatment group extended average PFS (survival period without progression of tumor) to 8.1 months, about 1.5 times longer (2.7 months longer than comparison group) than that of the comparison group with 5.4 months, in primary endpoint. The average survival period was evaluated to be 22.5 months and 16.9 months in the treatment group and comparison group, respectively, but they showed no statistical difference. And the treatment group and comparison group showed no difference in serious adverse effects.
Also, the ‘Immuncell-LC’-treated group demonstrated to be 30% higher in DCR with 82.4% than the comparison group with 63.4% (P = 0.0058).
“While glioblastoma is known as the most common primary malignant brain tumor in adults, it is difficult to conduct clinical trials with a large number of patients in short period of time as its frequency is far lower than tumor in other organs. Particularly, no data of randomized clinical study for combination immunotherapy using CIK-cells was published yet worldwide,” said Prof. Kim Choong-Hyun, the principal investigator. “Injection of large volume of CIK cells (about 660 million immune cells per dosage on average) produced by using own blood of patients with glioblastoma extended PFS by about 1.5 times and improved DCR by 30%.”
Prof. Kim Choong-Hyun have been prepared this clinical study since 2006, and his team began to conduct the study in December 2008 after drawing up the study plan for about 2 years and obtaining regulatory approval by Korean FDA, with large amount of financial support for clinical study costs by Green Cross Cell (KOSDAQ:031390).
CIK cell is a kind of immunocyte that can be obtained by coculture of patients’ own blood, interleukin-2(IL-2), and CD3 antibody ex vivo for 2~3 weeks. While very small numbers of CIK cells exist in the blood of normal person, they can be obtained in large volume by cultivating in laboratories. Repeated injection of these cells through vein for a certain period of time can effectively remove invasive tumor cells, which was not possible with standard therapies. And CIK cells can effectively remove tumor cells that survived by avoiding immune functions of patients. As immunocyte treatment using CIK cells is a therapy customized for individual patients, it costs much for producing such treatment, and scientists are seeking ways of reducing production costs and maximizing treatment effects.