Life Restarted! Chinese TIL Therapy Achieves Complete Tumor Clearance in 9 Weeks for Advanced Head and Neck Squamous Cell Carcinoma

Mr. Z becomesThe First Batch of "Crab-Eaters"Individuals enrolled in the clinical trial conducted by Shanghai Ninth People's Hospital—autologous tumor-infiltrating lymphocyte injection (GT201) for the treatment of advanced squamous cell carcinoma of the head and neck. This is a membrane-bound IL-15 complex-edited TIL therapy independently developed by China's Grail Bio based on their proprietary retroviral platform, StaVrial®.GT201By enhancing the persistence and functionality of TIL cells while alleviating the immunosuppressive effects in the tumor microenvironment, a new treatment option is provided for patients with advanced squamous cell carcinoma of the head and neck who have failed first-line therapy.

After surgically obtaining tumor tissue, the doctor extracted the most potent cancer-killing immune cells hidden within the excised tumor tissue—Tumor-Infiltrating Lymphocytes (TIL). These precious cells were expanded in the laboratory to reach tens to hundreds of billions in number. Following this, Mr. Z successfully underwent reinfusion after undergoing bridging therapy and pre-reinfusion conditioning at various stages.

Three weeks after the TIL infusion, Mr. Z experienced tumor shrinkage in multiple lesions, including the right submandibular area and cervical lymph nodes, achieving a partial clinical response (PR, with more than 30% reduction in target tumor lesions).

To everyone's great surprise, inWeek 9During the follow-up, Mr. Z's imaging showed that all tumor lesions had completely disappeared, reachingComplete Remission (CR)！

Before Treatment

9 Weeks After TIL Treatment

Mr. Z said excitedly during the interview: "I was thrilled when I heard the news, which proved that my choice to research at Grail Bio was right. I want to thank the doctors and nurses for their meticulous treatment and care, as well as the colleagues at Grail who are in charge of this research. Their efforts have given me new hope."

Now, the pain in Mr. Z's body, difficulty swallowing, hoarse voice, and other symptoms have gradually subsided. He can now walk and run comfortably, and most importantly, he can eat well and with enjoyment. With great energy, Mr. Z says, "My current goal is to maintain a regular routine and exercise. Although I still feel some tension during regular follow-ups, my mindset has fundamentally changed and improved compared to before I started treatment."

In September 2023, the research group of Professor He Yue from Shanghai Ninth People's Hospital, in collaboration with Grail Bio, applied for the second round of the "Three-Year Action Plan to Promote Clinical Skills and Clinical Innovation in Municipal Hospitals" initiated by the Shanghai Shenkang Hospital Development Center. The project focuses on the integration of medical and enterprise innovation collaboration. Professor He Yue's team at the Ninth Hospital is responsible for designing and conducting clinical trials targeting squamous cell carcinoma of the oral cavity and head and neck.

Professor He Yue, the project leader, pointed out: "The 5-year survival rate for patients with head and neck squamous cell carcinoma whose first-line treatment has failed is only about 20%, with very limited treatment options. The preliminary results of this clinical study show that GT201 has demonstrated good safety and encouraging efficacy in patients, building confidence for subsequent research and providing a new pathway for a new model of medical-enterprise cooperation."

(Note: To protect patient privacy, pseudonyms are used in the text, and details about the condition and treatment have been slightly abridged. For access to the original literature, please click the link at the end of the article.)

For decades, TILs therapy has been hailed as a novel immunotherapy with curative potential in the field of solid tumors.After 35 years of relentless efforts, on February 16, 2024, the highly anticipated new "king" of immunotherapy for all cancer patients, the world's first TIL therapy-Lifileucel (LN-144) Approved for Marketing in China –Amtagvi！ThisAn important and highly anticipated milestone for T-cell therapy,A New Era for Solid Tumor Treatment!Original link:Milestone! The world's first solid tumor TIL therapy, lifileucel, hits the market!

However$515,000 (approximately 3.7 million RMB)It is called "astronomical price" and has become the most expensive cancer immunotherapy currently available! So, how can Chinese patients benefit from it?

What is encouraging is that,Grail Bio has successfully independently developed the world's first innovative next-generation membrane-bound IL-15 complex-edited TIL therapy based on its proprietary retroviral platform StaVrial®.GT201。

Unlike traditional TIL therapy, GT201 achieves stable expression of membrane-bound IL-15 on tumor-infiltrating lymphocytes (TILs), aiming to enhance the persistence and functionality of TILs while improving immunosuppression within the tumor microenvironment. Compared with traditional TIL therapy, GT201 demonstrates stronger tumor-killing ability, increased cytokine release and persistence, and reduced dependency on IL-2. This optimizes the functionality and persistence of TIL therapy while lowering the required IL-2 dosage in clinical applications, resulting in fewer adverse effects.

According to a report by PR Newswire on August 30, 2024, the new drug GT201's IND has been approved by the U.S. Food and Drug Administration (FDA), paving the way for its official entry into the international market. Previously (in July 2023), it had received approval from China's Center for Drug Evaluation (CDE). Thus, GT201 has obtained "dual approval in China and the U.S.", allowing clinical trials targeting patients with advanced solid tumors to be conducted in both countries.

Exciting new clinical data on the safety and efficacy of GT201, a first-in-class autologous tumor-infiltrating lymphocyte monotherapy for advanced solid tumors, was presented at the 2024 American Society of Clinical Oncology (ASCO) meeting!

As of January 22, 2024, seven patients (including non-small cell lung cancer (NSCLC), malignant melanoma, cervical cancer, and ovarian cancer) have been enrolled to receive GT201 treatment. Among the evaluable patients, three patients (42.9%) achieved confirmed partial response (PR), and two patients (28.6%) showed stable disease (SD) as the best response.

Notably, in the non-small cell lung cancer subgroup, disease control (SD ≥ 24 weeks or any PR) was observed in all 3 patients (3/3, 100%).

Conclusion: For heavily pretreated patients with advanced or metastatic solid tumors, the infusion of GT201 following FC lymphodepletion and subsequent high-dose IL-2 demonstrated manageable safety. Notably, GT201 exhibited favorable clinical characteristics in NSCLC, with encouraging objective response rates, response durability, and no ≥Grade 3 adverse events related to GT201 treatment.

The good news is that currently GT201Clinical trials for advanced solid tumors are still ongoing, and many patients have successfully enrolled through the Global Oncology Doctors Network.

• Aged 18-75, regardless of gender;

• Diagnosed with ovarian cancer, colorectal cancer, malignant melanoma, etc.;

• Failed after standard treatment or lack of effective treatment methods;

• At least 2 lesions, physically suitable for minimally invasive surgical biopsy;

• ECOG score 0-1;
  

• With sufficient hematological and end-organ function.

If you are looking for help with TILs and other new anti-cancer treatments available in China and abroad, and your financial situation allows, you can first submit your medical records to the Medical Department of Global Oncology Doctors Network (400-666-7998) for an initial evaluation. Once approved, you may have the opportunity to receive free treatment with "astronomically priced" therapies.

Looking forward to TIL therapy in China transforming from 'exclusive to the wealthy' to 'universal healthcare,' benefiting more patients!

This article is original from Global Cancer Doctors Network. Reprinting is strictly prohibited without authorization.

Patient Concerns

---