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2024 ASCO China Highlights: China’s Indigenous TIL Therapy – GT101: Targeting Multiple Solid Tumors with a 90.9% Disease Control Rate

**2024 ASCO China Highlights: China’s Indigenous TIL Therapy Makes a Strong Debut, Targeting Small Cell Lung Cancer, Melanoma, Cervical Cancer, with a DCR Over 90%**

**GT101: Targeting Multiple Solid Tumors with a 90.9% Disease Control Rate**

TIL Therapy

TIL Therapy

GT101, independently developed by Gravel Biotech, is an autologous tumor-infiltrating lymphocyte (TIL) therapy. On April 22, 2022, its clinical trial implied consent was approved by the National Medical Products Administration (NMPA) (Acceptance No.: CXSL2200061). It is indicated for treating various solid tumors including non-small cell lung cancer, melanoma, and cervical cancer. Notably, GT101 is China’s first approved clinical TIL cell therapy and holds promise as the first cell therapy to conquer solid tumors!

Recently, at the 2024 ASCO Annual Meeting, results from the Phase 1 clinical trial of GT101 TIL therapy (NCT05430373) were announced. By November 10, 2023, a total of 14 patients with recurrent or metastatic solid tumors (including small cell lung cancer, melanoma, cervical cancer) had been enrolled, all with an ECOG performance status of 0 or 1 and having received a median of 2.6 prior lines of therapy. After enrollment, tumor tissue was obtained via appropriate surgical procedures for GT101 preparation, followed by approximately 30 days of TIL cell culture. Patients then underwent non-myeloablative lymphocyte depletion (cyclophosphamide + fludarabine), GT101 reinfusion therapy, and IL-2 (Interleukin-2) treatment.

1. **All enrolled patients (n=14):** The Objective Response Rate (ORR) was 35.7%. Among them, 28.6% (4 patients) achieved partial response (PR), 57.1% (8 patients) achieved stable disease (SD), and 7.1% (1 patient) achieved complete response (CR).

2. **In cervical cancer patients (n=11):** The Objective Response Rate (ORR) reached 45.5% (5/11). The Disease Control Rate (DCR) was as high as 90.9% (10/11), with 36.4% (4 patients) achieving partial response (PR) and 9.1% (1 patient) achieving complete response (CR). The median Progression-Free Survival (PFS) was 4.2 months. According to Kaplan-Meier statistics, the durations of complete response (CR) and progression-free survival (PFS) were 24 weeks and 36 weeks, respectively.

In conclusion, GT101 demonstrated promising clinical efficacy and manageable safety in combination with lymphocyte depletion and high-dose IL-2 treatment. Particularly in the treatment of cervical cancer, its objective response rate and duration of response are remarkable!

**How to Seek Help from TIL Therapy?**

The good news is that several TIL therapy clinical trials are currently recruiting in China, primarily targeting various solid tumors such as non-small cell lung cancer, melanoma, cholangiocarcinoma, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, breast cancer, ovarian cancer, cervical cancer, endometrial cancer, fallopian tube cancer, urothelial cancer, and renal cancer.

Patients seeking help from TIL therapy can submit their complete treatment history, recent pathology reports, imaging examination reports, and discharge summaries to Advanced Medicine in China

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Email: doctor.huang@globecancer.com

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