2024 ASCO China Voice: China’s TIL therapy – GC203: A Powerful Strike Against Ovarian Cancer with an 83.3% Disease Control Rate

2024 ASCO China Voice: China’s TIL therapy makes a grand debut, targeting ovarian cancer.

**GC203: A Powerful Strike Against Ovarian Cancer with an 83.3% Disease Control Rate**

TIL therapy

Ovarian cancer is a type of gynecologic tumor with a poor prognosis, with 70% of patients being diagnosed at a late stage. Unfortunately, effective treatment options for advanced ovarian cancer are quite limited, primarily relying on platinum-based chemotherapy. However, many ovarian cancer patients are not responsive to chemotherapy. Thus, there is an urgent need for new treatment options.

GC203 (mbIL-7-TIL) is a novel non-viral vector gene-modified TIL therapy utilizing membrane-bound IL-7. Developed by JunSai Biotech using the DeepTIL® cell expansion platform and NovaGMP® gene modification platform, it efficiently modifies T cells in a more economical way, enhancing the antitumor activity of TIL cells, activating internal immune cells, and avoiding systemic toxicity. It does not require lymphodepletion or combined IL-2 therapy post-infusion. A single patient is expected to save approximately 150,000 RMB in associated clinical costs, significantly improving the accessibility of TIL therapy and benefiting more cancer patients.

At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, the latest clinical study results of GC203’s Phase 1 trial (NCT05468307) were announced. Between September 2021 and January 2024, 20 patients with recurrent ovarian cancer were enrolled, having undergone a median of 2.5 lines (range 1-9) of chemotherapy regimens (including PARP inhibitors, immune checkpoint inhibitors, etc.). After enrollment, patients first underwent tumor tissue resection, which was transported to GMP for a 22-26 day preparation period. The cryopreserved infusion products were then returned to the clinical center. Finally, patients received lymphocyte depletion pretreatment (including cyclophosphamide and hydroxychloroquine), a one-time PD-1 antibody infusion, and GC203 TIL cell reinfusion therapy.

After a median follow-up of 8.7 months (range, 2.9-18.8 months), results from 18 evaluable patients showed the following:

1. **Objective Response Rate (ORR):** The ORR in evaluable patients (n=18) was 33.3% (95% CI: 16.3%-56.3%). Among them, 22.2% (4 patients) achieved partial response (PR), and 11.1% (2 patients) achieved complete response (CR).

2. **Disease Control Rate (DCR):** The DCR in evaluable patients (n=18) was 83.3% (95% CI: 60.8%-94.2%).

3. **Median Progression-Free Survival (PFS):** The median PFS was 5.5 months (range, 1.0-14.1 months).

4. **Overall Survival (OS) Rate:** The 6-month OS rate was 75.6% (95% CI: 57.4%-99.6%); the 12-month OS rate was 68.8% (95% CI: 49.3%-95.9%).

5. **Adverse Reactions:** Most treatment-emergent adverse events (TEAEs) were grade 1 or 2, with common adverse reactions including elevated C-reactive protein levels (33%), fever (33%), and fatigue (11%), which could be alleviated or cured with symptomatic treatment. No other serious adverse reactions were observed.

In summary, for patients with recurrent or metastatic ovarian cancer with limited treatment options, GC203 TIL cell reinfusion therapy has shown good efficacy. Due to low-intensity pretreatment and no need for combined IL-2 therapy, its safety is significantly improved compared to traditional TIL therapy.

**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.

WhatsApp: +8613717959070
Email: doctor.huang@globecancer.com

#OvarianCancer #TILTherapy #CancerTreatment #ASCO2024 #GC203 #Immunotherapy #MedicalResearch #Biotech #Oncology #ClinicalTrials #CancerInnovation #JunSaiBiotech #TIL #CancerBreakthrough #PatientCare #MedicalAdvancements

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12 months ago CAR-T

Breakthrough Ultra CAR-T Therapy Shows High Disease Control Rate of 85.7% in Advanced Platinum-Resistant Ovarian Cancer

Breakthrough Ultra CAR-T Therapy Shows High Disease Control Rate of 85.7% in Advanced Platinum-Resistant Ovarian Cancer

As a skilled overseas social media writer, here’s a revamped article for international media promotion:

 

In a groundbreaking development, PRGN-3005, an Ultra CAR-T cell therapy, is making waves with an impressive disease control rate (DCR) of 85.7% in the treatment of advanced platinum-resistant ovarian cancer. Utilizing non-viral gene delivery technology, this therapy eliminates the need for ex vivo expansion, significantly reducing production time and costs. The ability to administer the treatment rapidly, as soon as the second day after non-viral gene transfer, not only lowers production time and costs but also enhances tumor targeting precision. This holds the potential to disrupt the current landscape of CAR-T cell therapy.

 

Published in the Journal of Clinical Oncology, the “Phase 1/1b Clinical Trial of PRGN-3005 in Recurrent or Refractory (r/r) Ovarian Cancer” reported promising outcomes. The study included 25 assessable patients with a median age of 64 (range: 38-76) who had undergone extensive pretreatment with a median of 8 prior therapeutic regimens. The patients were divided into three groups: intraperitoneal (IP) infusion (C1, n = 12), intravenous (IV) infusion (C2, n = 6), and intravenous cyclophosphamide low dose (IV LD, n = 7).

 

Post-treatment, 20% of all participants exhibited regression in at least one target lesion (evaluated by RECIST 1.1 criteria). Notably, the DCR for the IV LD group was an impressive 85.7%, with a 57% reduction in target tumor burden and an average 27.4% decrease in CA125. A patient in the IV LD group experienced a 28% reduction in target tumor burden after a second PRGN-3005 infusion at the 12-month mark. Importantly, no PRGN-3005-related dose-limiting toxicities, neurotoxicities, or ≥3-grade cytokine release syndrome (CRS) adverse reactions were observed.

 

These results underscore the favorable tolerability of PRGN-3005 Ultra CAR-T therapy in treating ovarian cancer, demonstrating an encouraging disease control rate (DCR) and an overall reduction in tumor burden.

 

While CAR-T therapy has shown great promise in treating hematologic malignancies and several products have been approved, its application in solid tumor treatment is still in the clinical experimental stage. Nevertheless, with the continuous evolution of CAR-T generations, the emergence of more prominent targets, and improvements in proliferation and cytokine release aspects, the conquest of advanced solid tumors by CAR-T therapy seems imminent. Numerous clinical trials are already underway, offering hope for complete remission in fortunate patients.

 

#PRGN3005 #CARTTherapy #OvarianCancer #MedicalBreakthrough #CancerTreatment #Ovarian