JUNCELL's GC101 TIL Therapy Receives Approval for Pivotal Phase II Trial in Advanced Melanoma, Highlighting Enhanced Safety and Efficacy

Recently, Juncell Therapeutics announced that the first pivotal Phase II registration clinical trial of GC101 TIL injection has been approved by the National Medical Products Administration.ManagementApproved by the Center for Drug Evaluation (CDE) for advanced cases that have progressed or are intolerant to PD-1 antibody treatment.MelaninTumor patients (NCT06703398).

The trial will be conducted globallyMelanomaProfessor Guo Jun, an authoritative expert in the field and from Peking University Cancer Hospital, serves as the principal investigator, leading a multi-center clinical study across China.

GC101 is the world's first natural TIL cell therapy that does not require lymphodepletion or IL-2 injection. Its first indication has been approved to enter a pivotal Phase II clinical trial, marking a significant breakthrough in the field of solid tumor cell therapy. In China, the mortality rate of melanoma is relatively high, and its incidence has been increasing year by year. Compared with Caucasians in Europe and the United States, the characteristics of melanoma in China differ significantly: about 90% of melanomas in Caucasians originate in the skin, while in Asians and other people of color, approximately 50% of melanomas originate in the acral areas, and 20-30% originate in mucosal tissues. By comparison, the prognosis for acral and mucosal melanomas is poorer.

February 2024, United StatesFDAThe first TIL therapy, Lifileucel, has been granted accelerated approval for the treatment of patients with advanced melanoma who have progressed on or after second-line therapy. It demonstrated an objective response rate (ORR) of 31.5% and a median progression-free survival (mPFS) of 4.1 months. However, due to the need for high-intensity lymphodepleting chemotherapy and repeated administration of high-dose IL-2 during treatment, which triggered numerous adverse reactions, the FDA issued a black box warning.

GC101 is a TIL therapy developed by Juncell Therapeutics based on its proprietary DeepTIL® cell expansion platform. It can culture a sufficient number of highly active TIL cells without high concentrations of IL-2 or feeder cells and does not rely on IL-2. In clinical applications, GC101 demonstrates excellent efficacy without the need for lymphodepletion or any dose of IL-2 injection. Although the majority of GC101 subjects are patients with more difficult-to-treat acral and mucosal melanoma, its ORR is similar to that of Lifileucel, with mPFS extended by over a month. In terms of safety, GC101 subjects were treated in general wards, with no treatment-related deaths or ICU admissions, no patients requiring blood cell transfusions, and hospital stays reduced by approximately 80%.