Junshi Biosciences Announces Phase I Data of GC101 TIL Therapy in Heavily Pretreated Advanced NSCLC with 41.7% ORR at ESMO-IO 2025

2025ESMO Immuno-Oncology Congress (ESMO-IO)Held from December 10th to 12th in London, UK, as a top academic platform focusing on the frontier research and clinical practice of tumor immunology, the conference attracted leading experts and scholars as well as industry elites from around the world to participate in this grand event. 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 at the conference, which is not only...The world's first clinical study of TIL therapy for lung cancer that does not require high-intensity lymphodepleting chemotherapy or IL-2 administration, and also China's first registrational clinical study to publicly disclose data in this field.

Juncell Therapeutics' GC101 Demonstrates Outstanding Efficacy in the Treatment of Advanced Non-Small Cell Lung Cancer: Achieved in Heavily Pretreated Patients with a Median of Three Prior Lines of Therapy41.7% Objective Response Rate (ORR) and 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

Display Time:2025.12.10—12.12 Full Process

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 lymphodepletion chemotherapy or IL-2 administration, which has previously demonstrated good efficacy in Phase I clinical trials 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 subjects with advanced non-small cell lung cancer who have failed standard treatment.

Key Processes:

From August 2022 to September 2025, 12 patients with advanced non-small cell lung cancer received GC101 treatment. The median number of prior treatment lines was three. With a median follow-up time of 13.0 months (range: 1.5-31.0), the ORR was 41.7% (95% CI: 15.2%, 72.3%), and the median duration of response (DOR) has not yet been reached. The DCR was 66.7% (95% CI: 34.9%, 90.1%). The median overall survival has not yet been reached, and the 12-month overall survival rate was 66.7% (95% CI: 33.7%, 86.0%).

Best Percentage Change in Target Lesion Size Relative to Baseline

Juncell Therapeutics' Autologous Tumor-Infiltrating Lymphocyte (TIL) Therapy Demonstrates 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 Enhancement of Treatment Outcomes.

Despite the fact that advanced non-small cell lung cancer has entered the era of immunotherapy, clinical practice still faces severe challenges such as patients' tendency to develop resistance and the difficulty in maintaining long-term efficacy. Against this backdrop, GC101 TIL therapy from Juncell Therapeutics..."No specific target limitation, no need for high-intensity lymphodepletion chemotherapy, no need for IL-2 administration"The advantage brings new treatment options to tumor patients in dire 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.