TIL Therapy After PD-1 Failure: Where International Patients Can Access It
TIL therapy is not a "next thing to try" after PD-1 fails. It is a treatment category with a defined regulatory status, a defined eligibility profile, and a defined access map. Currently, only one TIL product is approved anywhere in the world — lifileucel (Amtagvi), approved by the FDA in February 2024 for unresectable or metastatic melanoma that has progressed after PD-1 therapy. China has not approved any TIL product. Domestic TIL pipelines remain investigational. Singapore has no locally approved TIL product and functions more as an evaluation and referral node than a treatment destination. For an international patient, real access depends on three things: whether you have a resectable lesion, whether you can wait 2–4 months for manufacturing and approval, and whether you can tolerate lymphodepletion and high-dose IL-2.
Quick Answer
TIL (tumor-infiltrating lymphocyte) therapy harvests lymphocytes that have already recognized the tumor, expands them in the laboratory to billions of cells, reinfuses them after lymphodepleting chemotherapy, and supports them with high-dose IL-2. The FDA granted accelerated approval to lifileucel (Amtagvi) in February 2024 for unresectable or metastatic melanoma that has progressed after PD-1 therapy (and BRAF-targeted therapy if BRAF V600 mutation-positive). In the C-144-01 trial (n=153), the objective response rate was 31.4% and the complete response rate was 5.2%; at 5-year follow-up, 31% of initial responders still had ongoing responses, and 5-year overall survival was 19.7%. China has no approved TIL product — domestic pipelines (Junshi GC101, Sandhill GT101/GT201, Huasai FAST-TIL, and others) are all in clinical trials. Singapore has no locally approved TIL product; it may function as a referral node, not a treatment site. Not every PD-1-failure patient is eligible: you need at least one resectable lesion (typically ≥1.5 cm), ECOG 0–1, adequate cardiac and pulmonary function, and the ability to wait 2–4 months for manufacturing and approval.
"PD-1 failed, so TIL is the next step." — Not automatically. TIL is approved only for melanoma, only after PD-1 (and BRAF-targeted therapy if BRAF-mutant), and only for patients who have a resectable lesion, adequate organ function, and the time to wait for manufacturing. For non-melanoma solid tumors, TIL remains investigational. And even for eligible melanoma patients, the 2–4 month wait between decision and infusion is itself a filter — if the disease cannot be bridged during that window, the opportunity may close before the cells are ready.
Who This Page Is NOT For
This page is not a tool to determine your eligibility for TIL therapy, and it is not an endorsement of any specific product, trial, or center. It is for patients, families, and referring physicians who want to understand what TIL therapy is, what its regulatory status is in different regions, and what the realistic access pathways are. Only your treating oncologist, with the full clinical picture, can determine whether TIL is appropriate for you.
How TIL Therapy Works
TIL therapy is a personalized cell therapy. It does not use engineered receptors (as CAR-T does). Instead, it uses the patient's own tumor-infiltrating lymphocytes — T cells that have already been selected by the tumor microenvironment for their ability to recognize cancer cells.
Tissue collection
A resectable tumor lesion (typically ≥1.5 cm) is surgically removed. This is why patients with only bone or brain metastases are usually excluded — there is no suitable lesion to harvest.
Laboratory expansion
The lymphocytes are isolated and expanded in the laboratory to billions to tens of billions of cells. This takes approximately 22 days, with additional time for quality control and logistics. The real-world turnaround is at least 35 days, and often 2–4 months when scheduling and approval are included.
Lymphodepleting chemotherapy
Before infusion, the patient receives lymphodepleting chemotherapy (typically cyclophosphamide and fludarabine) to create space in the immune system for the expanded TIL to engraft and expand further.
Infusion and IL-2 support
The expanded TIL are infused, followed by high-dose IL-2 to support their survival and proliferation. IL-2 is associated with significant toxicity (capillary leak syndrome, hypotension, organ dysfunction), which is why TIL is delivered at specialized centers with intensive care capability.
Regulatory Status by Region
| Region | lifileucel (Amtagvi) status | Other approved TIL products | What this means for international patients |
|---|---|---|---|
| United States | FDA accelerated approval (February 2024), for unresectable or metastatic melanoma after PD-1 therapy | None | Commercially available at authorized treatment centers; cost approximately US$515,000 |
| Canada | Health Canada conditional approval | None | Access depends on provincial reimbursement and center certification |
| Australia | Conditional approval (June 2026) | None | Recently opened; limited center coverage |
| China | Not approved. No lifileucel registration in NMPA database | None. Domestic TIL pipelines are in clinical trials | Clinical trial access only; no commercial pathway |
| Singapore | No local approval record | None | May function as a trial site or referral node, but no local commercial TIL |
| Europe / UK | Regulatory and reimbursement decisions pending | None | Not routinely accessible |
Who Is Eligible — and Who Is Not
Core eligibility criteria
- Unresectable or metastatic melanoma (other cancers: clinical trials only)
- Progression after PD-1 therapy (and BRAF ± MEK inhibitors if BRAF V600 mutation-positive)
- At least one resectable lesion for harvest (typically ≥1.5 cm)
- ECOG 0–1
- Cardiac LVEF ≥45%, pulmonary DLCO ≥40%
- No active uncontrolled infection
Common exclusion criteria
- No resectable lesion (e.g., bone-only or brain-only metastases)
- ECOG 3–4
- Severe cardiac dysfunction (LVEF <45%)
- Severe pulmonary dysfunction (DLCO <40%)
- Active uncontrolled infection
- Active autoimmune disease requiring immunosuppression
- Pregnancy or breastfeeding
China: No Approved Product, Investigational Pipelines Only
As of February 2026, China has no approved TIL product. All TIL therapies are in clinical trials. The more closely watched domestic pipelines include:
Domestic TIL pipelines
- Junshi GC101
- Sandhill GT101 / GT201
- Huasai FAST-TIL
- Baiji BST02
- Lanma LM103
What these data are — and are not
- Early-phase data, often in small numbers of patients
- Not an approved indication
- Not a guarantee of access
- Not a substitute for a registered trial
How to verify a Chinese TIL trial: The same logic applies as for CAR-T trials. You need a registration number (CTR or ChiCTR), it must be searchable on the CDE or ChiCTR platform, and the current status must be "recruiting." A "TIL treatment opportunity" that cannot produce a registration number cannot be verified.
Singapore: A Referral Node, Not a Treatment Destination
There is no public record of a locally approved TIL product in Singapore, and no clearly identified commercial TIL treatment center. Singapore has a regional referral function in some cell therapy areas (for example, CAR-T), but TIL is different: lifileucel manufacturing and supply are controlled by Iovance, and the authorized treatment center network is limited.
For patients considering Singapore, two things need to be separated:
1. Are there TIL trials recruiting in Singapore?
This requires checking ClinicalTrials.gov and any Singapore-specific trial registry. A trial site in Singapore would be a genuine access pathway — but it must be verified.
2. Is there a center that coordinates cross-border TIL referral?
This is not the same as receiving TIL in Singapore. It means a Singapore institution helps coordinate access to a center where TIL is available. The treatment itself would happen elsewhere.
A Fictional Example: The TIL Pathway Timeline
The example below is fictional. It is used only to show the time structure of a TIL pathway from decision to infusion. It is not derived from any real patient's records.
How to read this example: The timeline shows why TIL is not an emergency option. From decision to infusion, the realistic window is 2–4 months. During that time, the disease must be controlled with bridging therapy. If bridging fails, the opportunity may close before the cells are ready. This is why the conversation about TIL should start early — before the patient has exhausted all bridging options.
Questions to Bring to Your Oncologist
These questions are educational. They are not an assessment of your case. Review the answers with your licensed oncologist.
Is my cancer type and stage within the approved indication for TIL, or would this be a clinical trial?
TIL is approved only for melanoma after PD-1. Other cancers are trial-only.
Do I have a resectable lesion suitable for harvest?
Typically ≥1.5 cm, and not bone-only or brain-only. This is a hard eligibility gate.
Can my disease be controlled during the 2–4 month manufacturing window?
Bridging therapy options should be discussed before committing to TIL.
Is my cardiac and pulmonary function adequate for high-dose IL-2?
LVEF ≥45% and DLCO ≥40% are typical thresholds. Ask for your specific values.
If I am in China, is there a registered TIL trial I might be eligible for?
Ask for the registration number (CTR or ChiCTR) and verify it yourself.
If I travel abroad for TIL, what is the follow-up plan after I return home?
TIL requires weeks of monitoring after infusion. Ask how the handover to your local team will work.
Continue Your Research
Related reference pages on CAR-T and cell therapy access.
What Do the Terms in a Chinese CAR-T Treatment Record Mean?
Product names, cell types, complications, and follow-up terms.
CAR-T Clinical Trial Registry in China: How to Verify Trial Status
A framework for verifying registration, approval, and eligibility — three separate gates.
What Happens After CAR-T: The 12-Month Follow-Up Protocol
Month-by-month follow-up framework for the first year after infusion.
Frequently Asked Questions
Is TIL therapy approved in China?
No. As of February 2026, China has no approved TIL product. All TIL therapies in China are in clinical trials. Domestic pipelines (Junshi GC101, Sandhill GT101/GT201, Huasai FAST-TIL, Baiji BST02, Lanma LM103, and others) have published early-phase data, but these are not approved indications. Access in China is through clinical trials only.
Is TIL therapy available in Singapore?
There is no public record of a locally approved TIL product in Singapore, and no clearly identified commercial TIL treatment center. Singapore may function as a trial site or a referral node, but it is not currently a destination where TIL is commercially delivered. Patients considering Singapore should verify whether a specific trial is recruiting there, or whether a Singapore institution is coordinating referral to a center where TIL is available.
Can TIL be used for cancers other than melanoma?
Not outside clinical trials. The FDA approval of lifileucel is specifically for unresectable or metastatic melanoma after PD-1 therapy. In other solid tumors (cervical cancer, non-small cell lung cancer, head and neck cancer, breast cancer), TIL remains investigational. Access for non-melanoma cancers depends on whether a suitable clinical trial is open.
How long does it take from decision to infusion?
The real-world turnaround is at least 35 days (approximately 22 days of manufacturing plus quality control and logistics). When insurance authorization, surgical scheduling, and bed availability are included, many patients wait 2–4 months. During that time, the disease must be controlled with bridging therapy. If bridging fails, the opportunity may close before the cells are ready.
What is the cost of TIL therapy?
In the United States, the list price of lifileucel is approximately US$515,000, before hospitalization, IL-2, and follow-up costs. Actual out-of-pocket cost depends on insurance coverage and the center's financial arrangements. International patients typically pay out of pocket or through private arrangements. This page does not provide cost estimates for any specific center; those should be requested directly from the treating institution.
Where can I find the full list of Chinese medical document reference pages?
This page is part of a series of question-based reference pages on Chinese medical documents and cell therapy access. Related pages cover CAR-T treatment records, clinical trial verification, and post-CAR-T follow-up. You can find the full list on the Evidence Hub.
Sources & References
- FDA. FDA approves lifileucel for unresectable or metastatic melanoma. February 16, 2024. fda.gov ↗
- Iovance Biotherapeutics. Amtagvi (lifileucel) prescribing information. 2024. iovance.com ↗
- Sarnaik AA, et al. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. Journal of Clinical Oncology. 2021. PubMed ↗
- Betof Warner A, et al. Long-term outcomes of lifileucel in advanced melanoma (C-144-01). 2025. PubMed ↗
- ClinicalTrials.gov. Search results for TIL therapy trials in China and Singapore. clinicaltrials.gov ↗
- 中国临床试验注册中心 (ChiCTR). Search results for TIL therapy trials. chictr.org.cn ↗