Junshi Biosciences Announces Phase I Data of GC101 TIL Therapy in Heavily Pretreated Advanced NSCLC with 41.7% ORR at ESMO-IO 2025 and Files Hong Kong IPO
Juncell Therapeutics
Solid Tumor Cell Therapy Developer
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2025European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO)Recently held in London, UK, as a top academic platform focusing on cutting-edge research and clinical practice in tumor immunology, the conference attracted leading experts and industry elites from around the world. Juncell Therapeutics presented for the first time the Phase I clinical trial data of GC101 TIL for the treatment of advanced refractory non-small cell lung cancer, which is not only...The world's first clinical study of TIL therapy for lung cancer that does not require high-intensity lymphodepletion chemotherapy or IL-2 administration, and also the first registrational clinical study in China to publicly disclose data in this field.
Juncell Therapeutics' GC101 Demonstrates Outstanding Efficacy in the Treatment of Advanced Non-Small Cell Lung Cancer: Targeting the Median Line of TreatmentThird-lineFor advanced-stage patients, it has achieved41.7% Objective Response Rate（ORR）With a 66.7% Disease Control Rate（DCR）。
Abstract Number ：80P
Abstract Title:A Phase I Trial of Optimized Autologous Tumor-Infiltrating Lymphocyte Therapy Without Exogenous IL-2 in Patients with Advanced Non-Small Cell Lung Cancer
Principal Investigator: Professor Xu Jianming
Research Institution:Chinese PLA General Hospital
Tumor-Infiltrating Lymphocyte (TIL) Therapy Offers Important New Option for Patients with Advanced Non-Small Cell Lung Cancer Who Failed Standard Treatment[1]However, traditional TIL therapy relies on high-intensity lymphodepleting chemotherapy (high-dose cyclophosphamide + fludarabine) combined with high-dose IL-2, which often entails significant toxic side effects, limiting its clinical application.[2]。
Juncell Therapeutics' GC101 TIL therapy innovatively adopts a regimen that does not require high-intensity lymphodepleting chemotherapy or IL-2 administration, which has already demonstrated promising efficacy in the Phase I clinical trial for gynecological malignancies.[3]Based on this, this study further evaluates the therapeutic value of this improved natural TIL therapy in patients with advanced non-small cell lung cancer.
This study is a multicenter, open-label phase I clinical trial (NCT05417750), enrolling patients with advanced non-small cellLung CancerAll subjects had failed standard treatment.
Key Processes:
Best Percentage Change in Target Lesion Size Relative to Baseline
Juncell Therapeutics' Autologous Tumor-Infiltrating Lymphocyte (TIL) Therapy Shows Promising Efficacy in Non-Small Cell Lung Cancer Patients Who Failed Multiple Lines of Treatment, Providing Important Clinical Evidence for Further Expansion of Lung Cancer Indications, Exploration of Combination Strategies with Immune Modulators, and Improvement in Therapeutic Outcomes.
Despite the fact that advanced non-small cell lung cancer has entered the era of immunotherapy, clinical practice still faces serious challenges such as patients' susceptibility to drug resistance and the difficulty in maintaining long-term efficacy. Against this backdrop, GC101 TIL therapy from Juncell Therapeutics..."No specific target limitation, no intensive lymphodepletion chemotherapy required, no IL-2 administration needed"The advantage brings new treatment options to tumor patients in desperate situations.
References:
1. Schoenfeld Adam J., et al. Cancer Discov. 2024. 14(8): p. 1389-1402.
2. Tseng Diane, et al. Transplant Cell Ther. 2025. 31(3S): p. S599-S609.
3. Guo Jing, et al. Bmc Med. 2024. 22(1): p. 207-207.
