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Approval of #Liver Cancer CAR-T Product Targeting #GPC3 Propels China’s CAR-T Therapy Forward
Approval of #Liver Cancer CAR-T Product Targeting #GPC3 Propels China’s CAR-T Therapy Forward
Liver cancer, CAR-T
CT011
On January 15, 2024, #CARsgen Pharmaceuticals announced that its autologous #CARTcell candidate product #CT011, targeting Glypican-3 (GPC3), has been approved for clinical use in China. It is intended for the treatment of GPC3-positive stage IIIa hepatocellular carcinoma patients at risk of recurrence after surgical resection.
Glypican-3 (GPC3)
Glypican-3 (GPC3)plays a crucial role in regulating cell growth and differentiation and is closely associated with the occurrence and progression of liver cancer. GPC3 is expressed in reproductive system tumors such as hepatocellular carcinoma, ovarian clear cell carcinoma, and yolk sac tumors. Its expression rate in hepatocellular carcinoma reaches 74.8%, while it is virtually absent in normal liver tissue, making it an ideal new target for #livercancer #CARTtherapy.
Promising Target
Due to its tumor specificity, GPC3 is considered a promising target for cancer immunotherapy. Higher expression of GPC3 in hepatocellular carcinoma is associated with poorer prognosis.
Frontiers in Immunology
In August 2022, a Chinese medical team published a long-term survival case report of treating advanced hepatocellular carcinoma with CT011 in the journal “#FrontiersinImmunology.” The study reported complete remission (#CR) and long-term survival in a patient with advanced hepatocellular carcinoma after receiving GPC3 CAR-T cell therapy in combination with the multi-target kinase inhibitor sorafenib.
Results showed good tolerance to CT011 combined with sorafenib treatment. The patient achieved partial remission (PR) from the third month onwards and attained complete remission at the 12th month after the first CT011 infusion. The tumor did not progress for over 36 months, maintaining complete remission status for over 24 months after the first infusion.
Cancer Communications
On October 12, 2023, CARsgen Pharmaceuticals announced the clinical efficacy of its independently developed CAR-T cell therapy targeting GPC3 in two patients with advanced hepatocellular carcinoma (HCC). The clinical trial results were published in “#CancerCommunications.” Both patients had inferior prognostic outcomes upon enrollment, with one having inferior vena cava tumor thrombus and the other having retroperitoneal lymph node metastasis.
In the clinical trial, one patient received local treatment for intrahepatic recurrent tumors and inferior vena cava tumor thrombus (microwave ablation and gamma knife) before receiving CAR-T cell therapy targeting GPC3. Six months later, AFP (alpha-fetoprotein) levels normalized, and imaging revealed no active tumors. The other patient underwent local treatment (microwave ablation and gamma knife) for controlling intrahepatic tumors, inferior vena cava tumor thrombus, and peritoneal lymph node metastases while receiving CAR-T cell therapy.
Encouragingly, both patients showed significant efficacy after combined local treatment and CAR-T cell infusion, maintaining tumor-free status during long-term follow-up, with both individuals being tumor-free for over 7 years. Throughout the follow-up period, both patients only received oral antiviral therapy for hepatitis B and did not undergo any other cancer treatment.
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Unveiling Hope: Chinese CAR-T Cell Therapy Illuminating New Paths in Liver Cancer Treatment!
2020, over 19.3 million people were diagnosed with cancer worldwide, leading to almost 10 million fatalities. In China alone, the number of new cancer patients reached a staggering 4.57 million, accounting for 23.7% globally. Liver cancer, among the most prevalent malignant tumors in China, witnessed 410,000 new cases and 380,000 deaths, making up 45.3% and 47.1% of the global total, respectively [1]. However, since the 21st century began, significant strides have been made in liver cancer treatments, particularly in medication and localized therapies. Surgical procedures are no longer the sole option for long-term survival among liver cancer patients.
Immunotherapy has emerged as one of the most promising techniques for treating liver cancer, especially with advancements in tumor molecular biology. In 2013, “Science” magazine categorized immunotherapy as the fourth major cancer treatment, following surgery, chemotherapy, and radiation therapy, with cell therapy becoming a focal point of basic and clinical research in recent years.
In May 2020, Professor Zhai Bo’s team from Shanghai Jiao Tong University School of Medicine’s Renji Hospital, in collaboration with Shanghai Sci-Tech Biotechnology’s team led by Li Zonghai, published groundbreaking preliminary clinical research data on CAR-T cell therapy targeting the GPC3 gene for hepatocellular carcinoma in the “Clinical Cancer Research” journal. This breakthrough study brought unprecedented hope for CAR-T cell therapy in liver cancer treatment.
Even more inspiring, their publication in the “Cancer Communications” journal showcased follow-up results of two late-stage liver cancer patients who achieved long-term tumor-free survival after receiving CAR-T cell combined with local therapy [2]. These findings shed new light on the treatment prospects for liver cancer patients.
However, despite the potential therapeutic effects of liver cancer CAR-T cell therapy, it faces challenges and obstacles. Liver cancer’s heterogeneity, tumor microenvironment, and the safety of cell therapy remain crucial issues to address.
Presently, revolutionary changes are underway in the treatment models and concepts for liver cancer. However, integrating CAR-T cell therapy into actual liver cancer treatment requires further scientific exploration and clinical research. Researchers emphasize that only through comprehensive utilization of CAR-T cells in conjunction with other treatment modalities can its therapeutic potential be fully realized.
Professor Zhai Bo’s team is currently conducting various fundamental and clinical studies aimed at exploring additional possibilities for CAR-T cell therapy in solid tumors. These studies include phase I clinical research on EpCAM CAR-T cell combined with ablative therapy for gastrointestinal tumors, phase II clinical research on Claudin18.2 CAR-T cell therapy for gastrointestinal tumors, studies on the mechanism and prevention of OTOT toxicity, among others. These endeavors will provide more experimental data and support for the application of CAR-T cells in the treatment of solid tumors.
In conclusion, liver cancer CAR-T cell therapy signifies a significant breakthrough in the field of liver cancer treatment, offering new hope for patients. Despite the challenges to overcome, the outlook for this therapy is promising and holds the potential to bring a blessing to more patients in the future.
[References]
Zhaibo, Lizonghai etc.
“Chimeric Antigen Receptor-Glypican-3 T-Cell Therapy for Advanced Hepatocellular Carcinoma: Results of Phase 1 Trials.” 《Clinical Cancer Research》, 2020.
“Combined local therapy and CAR-GPC3 T-cell therapy in advanced hepatocellular carcinoma: a proof-of-concept treatment strategy.” 《Cancer Communications》, 2023.
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