GC Cell Expects Immuncell-LC to Overcome Pancreatic Cancer Following Liver Cancer Success... Phase 3 IND for Pancreatic Cancer Submitted

Submission of Phase 3 Clinical Trial Plan for Immuncell-LC to Expand Indications for Pancreatic Cancer
Aiming to Demonstrate Superiority Over Standard Treatment for Pancreatic Cancer, the Cancer With the Lowest Five-Year Survival Rate

[Asia Economy, reporter Park Hyungsoo] GC Cell, a company specializing in cell therapy, announced on July 6, 2020, that it has submitted an Investigational New Drug (IND) application for a Phase 3 clinical trial of Immuncell-LC for pancreatic cancer to the Ministry of Food and Drug Safety.

The Phase 3 clinical trial for pancreatic cancer is a commercial trial aimed at adding a new indication for Immuncell-LC. The study will evaluate the efficacy and safety of Immuncell-LC in combination with gemcitabine, compared to gemcitabine monotherapy, in 454 patients with pancreatic cancer.

Due to the nature of the pancreas, early detection of pancreatic cancer is difficult. The incidence is highest among patients in their 70s (32.8%), followed by those in their 60s (25.4%) and those aged 80 or older (19.4%), making anticancer treatment particularly challenging. In fact, the five-year relative survival rate for pancreatic cancer is 12.2%, the lowest among the top 10 major cancers, and there has been little improvement despite advances in medical technology, making it a particularly intractable disease.

The goal of this clinical trial is to reduce the recurrence and progression rates of cancer and to improve survival rates by administering gemcitabine, the standard treatment for pancreatic cancer, in combination with Immuncell-LC.

Immuncell-LC was approved as an anticancer drug for liver cancer in 2007. In 2015, the results of a Phase 3 clinical trial involving 230 liver cancer patients were published in the journal ‘Gastroenterology,’ attracting global attention.

The first clinical paper on Immuncell-LC was published in 2014 in ‘Cancer Immunology, Immunotherapy,’ presenting the results of an investigator-initiated clinical trial in patients with terminal pancreatic cancer.

In a study involving patients with stage IV pancreatic cancer, Immuncell-LC demonstrated a response rate of 25% and a progression-free survival (PFS) of 11 weeks. The study confirmed its potential as a second-line anticancer therapy. By utilizing the patient’s own immune cells, the treatment was evaluated as having fewer side effects and being considerate of the patient’s quality of life.

If the clinical trial plan is approved, 454 pancreatic cancer patients will be recruited at Seoul National University Hospital and 14 other clinical institutions. The trial will be conducted as a randomized, open-label, multicenter study.

Lee Deukjoo, CEO of GC Cell, stated, “There has been significant demand from both patients and researchers for clinical trials in pancreatic cancer,” adding, “We expect that Immuncell-LC will provide more treatment opportunities and benefits to pancreatic cancer patients, following its success in liver cancer.”

Recently, GC Cell established advanced cGMP-level facilities and production systems optimized for cell therapy manufacturing in Yongin. By introducing a computerized system for advanced management and production, the company has secured the largest cell therapy manufacturing facility in Korea that meets global standards.

This content was produced with the assistance of AI translation services.