Investigational Drug
LN-145
TrialFetch AI Analysis
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Overview
LN-145 (lifileucel) is a personalized tumor-infiltrating lymphocyte (TIL) therapy. It remains investigational for cervical cancer and other uses, but is FDA-approved in the United States as Amtagvi for certain adults with unresectable or metastatic melanoma after prior treatment. The melanoma indication received accelerated approval in February 2024; continued approval may depend on a trial confirming clinical benefit. (ascopubs.org)
Mechanism of action
T cells are collected from a patient’s tumor, expanded outside the body, and infused back into the patient to attack cancer cells. Treatment also includes chemotherapy to reduce existing lymphocytes before infusion and interleukin-2 afterward to support the infused cells. Rather than targeting one specified molecule, the product contains a mixture of tumor-derived T cells. (pubmed.ncbi.nlm.nih.gov)
Efficacy
- Melanoma: In the single-arm phase 2 study supporting approval, 23 of 73 patients (31.5%) responded, including three complete responses. Median response duration had not been reached at the FDA’s analysis. A later five-year analysis of a broader 153-patient study population reported a 31.4% response rate and a median response duration of 36.5 months. These were not comparisons against another treatment. (aacrjournals.org)
- Cervical cancer: An early phase 2 conference abstract reported a 44% response rate among 27 previously treated patients. This small, uncontrolled result is preliminary and does not establish benefit in cervical cancer. (ascopubs.org)
Safety
Treatment can cause serious harm. Across 156 lifileucel-treated patients in the melanoma study’s primary and supportive cohorts, 95.5% experienced a grade 3 adverse event and 87.8% a grade 4 event. The U.S. prescribing information carries a boxed warning for treatment-related death, prolonged severe low blood-cell counts, severe infection, and heart, lung, or kidney impairment. These risks are assessed in the context of the whole treatment regimen, including lymphodepleting chemotherapy and interleukin-2. (aacrjournals.org)
Further reading
- FDA approval summary and trial analysis
- Five-year melanoma study results
- Cervical cancer phase 2 conference abstract
Last updated: Sep 2026
Active trials using LN-145
Found 6 active trials using this drug:
TrialFetch AI summary: Adults with unresectable, recurrent, or metastatic cutaneous squamous cell carcinoma or Merkel cell carcinoma after checkpoint inhibitor therapy receive autologous lifileucel, tumor-derived T cells expanded to attack cancer cells. Treatment includes tumor harvest, fludarabine/cyclophosphamide lymphodepletion, a single lifileucel infusion, and up to six doses of interleukin-2.
ClinicalTrials.gov ID: NCT07288073
TrialFetch AI summary: This trial enrolls HLA-A*02:01-positive patients with unresectable or metastatic cutaneous melanoma, including acral melanoma, whose disease progressed on or after PD-1 therapy; patients with BRAF-mutant disease generally must also have received BRAF-directed therapy. It compares autologous IMA203, a T-cell receptor therapy targeting a PRAME peptide presented by HLA-A*02, after lymphodepletion and followed by low-dose IL-2, with investigator-selected immunotherapy, lifileucel, or chemotherapy.
ClinicalTrials.gov ID: NCT06743126
TrialFetch AI summary: Adults with advanced endometrial carcinoma, including carcinosarcoma, who have progressed after platinum chemotherapy and anti-PD-1/PD-L1 therapy receive lifileucel, an autologous tumor-infiltrating lymphocyte therapy made from a resected tumor. Treatment includes lymphodepleting chemotherapy before lifileucel infusion and interleukin-2 afterward; patients need a resectable tumor lesion and a separate measurable lesion.
ClinicalTrials.gov ID: NCT06481592
TrialFetch AI summary: Adults with metastatic uveal melanoma or unresectable/metastatic undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma receive personalized autologous tumor-infiltrating lymphocytes (lifileucel, LN-144/LN-145) after tumor excision and lymphodepleting chemotherapy, followed by interleukin-2. Sarcoma patients generally must have received prior systemic therapy; the infused lymphocytes may recognize multiple tumor antigens rather than a single specified target.
ClinicalTrials.gov ID: NCT05607095
TrialFetch AI summary: Adults with metastatic NSCLC lacking EGFR, ALK, or ROS1 alterations and generally progressing after checkpoint inhibition and platinum chemotherapy receive LN-145 (lifileucel), autologous tumor-derived T cells expanded ex vivo, after lymphodepleting chemotherapy, followed by interleukin-2.
ClinicalTrials.gov ID: NCT04614103
TrialFetch AI summary: Patients with unresectable or metastatic melanoma, recurrent or metastatic head and neck squamous cell carcinoma, or stage III–IV non-small cell lung cancer receive autologous tumor-infiltrating lymphocytes (lifileucel/LN-144, LN-145, or PD-1-selected LN-145-S1) after lymphodepleting chemotherapy, followed by aldesleukin. Depending on the cohort, treatment is given alone or with checkpoint inhibitors; some frontline lung cancer cohorts also receive platinum-doublet chemotherapy plus pembrolizumab.
ClinicalTrials.gov ID: NCT03645928
