GC Cell announced on the 30th that the results of a long-term clinical study of its immune cell therapy “Immuncell-LC Inj.” in patients with hepatocellular carcinoma have been published in an international academic journal.

According to GC Cell, the study integrated approximately nine years of long-term follow-up data from patients who participated in a Phase 3 randomized controlled trial (RCT) with large-scale real-world clinical data (Real-World Data, RWD) collected in actual treatment settings. GC Cell explained that the research focused on evaluating the long-term clinical efficacy of Immuncell-LC Inj. in hepatocellular carcinoma patients who remain at high risk of recurrence even after curative treatment.

The company stated that in the long-term follow-up analysis of subjects in the Phase 3 clinical trial, the median recurrence-free survival (mRFS) in the Immuncell-LC Inj. treatment group was extended by 14 months compared with the control group, and the risk of recurrence was reduced by 28%.

In the overall survival (OS) analysis, a trend toward reduced mortality risk was observed in the treatment group.

Furthermore, cancer-specific survival (CSS), measured based solely on deaths caused by cancer, was significantly improved in the treatment group, with cancer-related mortality risk reduced by 51%, according to the company.

GC Cell also explained that in a long-term follow-up analysis based on real-world clinical data from two tertiary medical institutions in Korea, the median recurrence-free survival in the Immuncell-LC Inj. treatment group was extended by 35.5 months compared with the control group, and the risk of recurrence was reduced by 36%.

Professor Lee Jeong-Hoon of the Division of Gastroenterology at Seoul National University Hospital, who led the study, said, “Following the Phase 3 liver cancer clinical trial, which demonstrated safety and efficacy, long-term follow-up over nine years and analysis of real-world data (RWD) confirmed the evidence that immune cell therapy has clinical utility as a sustained adjuvant immunotherapy strategy for liver cancer,” adding, “In a situation where even large-scale multinational clinical trials using immune checkpoint inhibitors to reduce liver cancer recurrence have recently failed, the value of Immuncell-LC Inj., which can reduce liver cancer recurrence over the long term, is even greater.”

Won Sung-Yong, CEO of GC Cell, said, “It is very meaningful that these long-term follow-up clinical results have been officially published in a journal,” and added, “Based on the clinical evidence accumulated in the domestic market, we hope it will become a reliable treatment option for liver cancer patients and healthcare professionals.” He continued, “Building on this achievement, we will make every effort toward future overseas expansion.”

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