Tumor-Infiltrating Lymphocyte (TIL) therapy is a highly promising form of Adoptive Cell Therapy (ACT), demonstrating significant potential in the treatment of solid tumors. Both as a monotherapy and in combination regimens, TIL therapy has brought durable clinical remission and survival benefits to patients. Particularly in the field of advanced melanoma, the efficacy of TIL therapy has been confirmed by the latest research, establishing it not only as an important treatment direction but also incorporating it into the 2024 NCCN guidelines, making it the preferred second-line option for this condition.

Recently, the journal *Experimental Hematology & Oncology* published a report summarizing the latest developments in TIL therapy for solid tumors presented at the 2025 ASCO (American Society of Clinical Oncology) conference. This includes efficacy data for monotherapy/combination therapies, technological innovations, and explorations into applications across multiple cancer types. To provide new directions and options for patients trapped in the困境 of cancer, the global oncology editorial team has promptly compiled the notable breakthroughs in TIL therapy from this conference for reference by those affected by cancer!

▲Screenshot source“PMC”

Lifileucel: The World's First FDA-Approved TIL Therapy, with a 5-Year Overall Survival Rate of Nearly 20% for Melanoma

PART 1

Lifileucel is a personalized, one-time tumor-derived autologous T-cell immunotherapy, asThe World's First FDA-Approved TIL Therapy for Melanoma, has been officially included in the 2024 NCCN guidelines.

The 2025 ASCO Conference unveiled the latest 5-year results of the Phase II C-144-01 trial for Lifileucel. The trial enrolled 153 patients with advanced melanoma refractory to PD-1 inhibitors, and its 5-year follow-up represents the longest prospective follow-up for Lifileucel and second-line treatment drugs for immune checkpoint inhibitor (ICI)-resistant melanoma, marking a milestone achievement.

Results show:Objective Response Rate (ORR) was 31.4%(48/153), that isOver 30% of Patients Show Significant Tumor Reduction or Disappearance; among whichComplete Response (CR) Rate 5.9%, Partial Response (PR) Rate 25.5%(See the figure below for details).Median Duration of Response (DOR) was 36.5 months, with 31.3% of responders still maintaining response at 5 years.。

In addition,Median Overall Survival (OS) 13.9 Months(See the figure below),The 5-year OS rate was 19.7%.For patients with advanced melanoma, especially those who have progressed after multiple lines of treatment and have limited options following immune checkpoint inhibitor (ICI) therapy, this data is of significant importance:Nearly 20% of Patients Can Cross the 5-Year Survival Milestone，The one-time Lifileucel therapy brings lasting efficacy and tangible survival hope to this group with poor prognosis.

GT201: ORR exceeds 55% in advanced solid tumors, 100% control in non-small cell lung cancer subgroup, complete remission achieved in oral cancer patients

PART 2

GT201 is a novel TIL therapy developed by Grail Bio, characterized by the expression of mbIL-15 on TILs, aiming to enhance immune activation within the tumor microenvironment (TME) and eliminate IL-2 toxicity.

The phase I clinical trial results were presented at the 2025 ASCO conference: For patients with advanced solid tumors who did not respond to standard therapies (median age 52, median of 2 prior lines of therapy), GT201 was infused after lymphodepletion, followed by IL-2 administration. Among the 9 evaluable patients, cancer types included head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), melanoma, cervical cancer, and ovarian cancer.

Results showed:Objective Response Rate (ORR) Reached 55.6%（5/9），Disease Control Rate (DCR) as high as 77.8%(7/9); among whichOne case (11.1%) achieved complete remission (CR), four cases (44.4%) achieved partial remission (PR), and two cases (22.2%) achieved stable disease (SD).. It is worth noting that,All 3 patients in the non-small cell lung cancer (NSCLC) subgroup achieved disease control (SD≥24 weeks or PR).，Control rate reached 100%（3/3）。

▲Screenshot source“ASCO”

Previously published typical cases show,One patient with partial response (PR) had a Virchow lymph node in the left supraclavicular fossa (46.7mm before treatment), which decreased by 69% after 4 months of GT201 treatment.(See the figure below for details).

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In addition to the latest data from ASCO, a single-arm clinical study of GT201 combined with PD-1 inhibitors for the treatment of advanced head and neck squamous cell carcinoma has completed the first cell infusion in an oral cancer participant at Shanghai Ninth People's Hospital, showing equally impressive efficacy. The participant is a 61-year-old male who was diagnosed with laryngeal cancer in August 2016 due to hoarseness and a foreign body sensation in the throat, and was cured after surgery and adjuvant radiotherapy and chemotherapy. In September 2023, he was diagnosed with floor-of-mouth cancer (a type of head and neck squamous cell carcinoma, with mandibular bone invasion and multiple cervical lymph node metastases) due to a mass on the right side of the mouth floor. As surgical resection could lead to severe speech and swallowing dysfunction as well as disfigurement, the patient opted out of surgery. Moreover, after multiple rounds of chemotherapy and targeted therapy, the tumor still progressed rapidly. He then enrolled to receive GT201 treatment (combined with bridging therapy and subsequent maintenance therapy).

The results showed:Only 3 weeks after TIL infusion, the patient's lesion significantly reduced, reaching clinical partial response (PR).; At the 9-week follow-up after treatment,Imaging evaluation showed that all lesions had completely disappeared, successfully achieving complete remission (CR).(See the figure below for details).

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OBX-115

PART 3

OBX-115 is a next-generation autologous engineered tumor-infiltrating lymphocyte (TIL) therapy that expresses membrane-bound IL-15 (mbIL-15) regulated by the small-molecule drug acetazolamide (ACZ). It eliminates the need for high-dose, highly toxic IL-2 support post-infusion, offering improved safety. On September 3, 2024, the drug received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for the treatment of unresectable or metastatic melanoma resistant to immune checkpoint inhibitors (ICI).

In a Phase 1 clinical study (NCT05470283), nine patients with metastatic melanoma who were resistant to immune checkpoint inhibitors (ICI) sequentially received lymphodepletion therapy (cyclophosphamide + fludarabine) + OBX-115 reinfusion + ACZ treatment, without the use of systemic IL-2.

Results showed that: patients treated with OBX-115 combined with ACZObjective Response Rate (ORR) Reached 44.4%, including2 cases of complete remission (CR) and 1 case of partial remission (PR)；55.6% of patients (5 cases) achieved stable disease (SD) lasting at least 12 weeks.。None of the enrolled patients showed disease progression,Disease Control Rate (DCR) Reaches 100%; At week 24 of treatment,Progression-Free Survival (PFS) Reached 75%(See the table below for details).

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GT101

PART 4

GT101 is a tumor-infiltrating lymphocyte (TIL) product developed by Grit, utilizing a novel manufacturing process to enhance both yield and quality, initially evaluated in cervical cancer patients.

A multicenter Phase I clinical trial (NCT05430373) for metastatic/recurrent cervical cancer patients who are refractory to standard treatments demonstrated that 11 patients (median age 48, previously received 2 lines of therapy) were infused with GT101 after lymphodepletion, followed by high-dose IL-2 treatment.

The results showed that: the therapy had significant efficacy,Objective Response Rate (ORR) Reached 45.5%(5/11), where1 case (9.1%) achieved complete remission (CR), and 4 cases (36.4%) achieved partial remission (PR).；Disease Control Rate (DCR) Reaches Up to 90.9%(10/11), another5 cases (45.5%) achieved stable disease (SD)。Median progression-free survival (PFS) was 4.83 months., the median overall survival (OS) has not been reached. In terms of safety, GT101 showed acceptable performance, with the majority of treatment-emergent adverse events (TEAEs) being grade 1-2 in severity.

It is worth noting that, among themThe duration of complete remission (CR) in one patient reached 14.5 months.The patient has stage IIIC2 cervical squamous cell carcinoma, underwent metastatic lymph node resection surgery, with a baseline sum of target lesions (SOD) of 71.57mm.Reduced to 29.12mm after 28 days of treatment; At week 12 of GT101 treatment, imaging showedThe lesion has completely disappeared, officially reaching CR.。

▲Screenshot source“ASCO”

HS-IT101: China's first TIL therapy to enter clinical trials for solid tumors

PART 5

HS-IT101 isChina's First Independently Developed TIL Therapy to Enter Clinical Trials for Solid TumorsAs a novel non-GMO TIL product, it requires only low-dose lymphodepletion and IL-2 support due to improved production technology, significantly reducing safety risks while enhancing cell viability and clinical accessibility.

In a Phase I clinical trial for advanced solid tumors, six patients with melanoma were enrolled and received HS-IT101 treatment under a low-intensity regimen after enrollment.

The results showed that: the therapy demonstrated excellent efficacy and safety.Objective Response Rate (ORR) reached 50%, Disease Control Rate (DCR) reached 100%., among which16.7% (1/6) of patients achieved complete remission (CR), and 33.3% (2/6) of patients achieved partial remission (PR)., and no serious adverse events (SAE) were reported.

The good news is that multiple TIL cell therapies are currently undergoing clinical research.Read the original article for more details: [Free Recruitment for TILS Cell Therapy] HS-IT101 TIL Therapy has finally started clinical trials! Currently recruiting patients with solid tumors!

LM103: The first TIL product in China using trophoblast technology and granted clinical approval by the NMPA

PART 6

LM103 is a novel TIL therapy developed by Suzhou Lanma Medical. It optimizes production efficiency and product quality through the use of feeder cells (i.e., nourishing cells). On July 13, 2023, the drug received implied clinical trial approval from the NMPA (intended for the treatment of advanced solid tumors).The First TIL Product in China to Adopt Trophoblast Technology and Gain Clinical Approval。

In a Phase I clinical trial, Asian patients with metastatic melanoma who progressed after receiving standard treatment were enrolled. After lymphocyte depletion, they received intravenous infusion of autologous LM103, followed by high-dose IL-2 treatment.

The results showed that: among the 8 patients whose efficacy could be evaluated,LM103 Achieves 50% Objective Response Rate (ORR)(4/8, all Partial Response (PR)); Median Progression-Free Survival (PFS) has not been reached,The longest PFS was 11.4 months.Notably, durable remission was observed in patients with a CD8+ T cell proportion between 60% and 80%, and the therapy was well-tolerated with excellent safety.

GT300: The First CRISPR/Cas9 Dual-Knockout Anti-Exhaustion TIL Product to Enter Pivotal Clinical Development for Solid Tumors

PART 7

GT300, developed by Grail Biotechnology, isThe First CRISPR/Cas9 Dual-Knockout Anti-Exhaustion TIL Product to Enter Pivotal Clinical Development for Solid Tumors, aiming to enhance TIL function and overcome the immunosuppressive tumor microenvironment (TME). This product has high editing efficiency and few off-target events, and is intended for the treatment of cold tumors such as ovarian cancer and colorectal cancer.

In a Phase I study of advanced refractory gynecological cancers, 5 patients received GT300 infusion after lymphocyte depletion, and 4 of them subsequently received additional IL-2 infusion.

Results show that: GT300 demonstrates good clinical efficacy and safety:Objective Response Rate (ORR) Reached 60%(3/5), containingComplete Response (CR) 40% (2/5), Partial Response (PR) 20%(1/5), and no long-term safety issues were found.

Tumor-Infiltrating Lymphocyte (TIL) therapy, since its first clinical attempt in 1988, has undergone more than 30 years of development. Compared with other immunocyte therapies, it possesses the magical ability to "turn waste into treasure" using the patient's own tumor tissue, making it an undeniable anti-cancer breakthrough in the field of solid tumor treatment!

The latest advances in these seven TIL therapies, released at the 2025 ASCO Conference, once again validate the potential of TIL therapy in cancer treatment, particularly in enhancing efficacy and selectivity. They can be used for early-stage cancer patients to prevent tumor recurrence and metastasis, as well as serve as a salvage treatment option for advanced patients, offering a ray of hope to cancer patients!

The good news is that TILs therapy has now been officially approved for clinical research in China, primarily targetingNon-small cell lung cancer, cervical cancer, cholangiocarcinoma, breast cancer, ovarian cancer, esophageal cancerand other types of solid tumors. Patients seeking help with TIL therapy can submit their treatment history, recent pathology, and genetic test results toGlobal Cancer Doctors Network Medical Department (400-666-7998), for preliminary evaluation.