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LN-145 · 4 trials · 11 indications
Tumor-infiltrating lymphocyte (TIL) production is defined by the successful tumor harvest that leads to a manufacturing of a TIL product that contains ≥ 1 x 10\^9 cells.
TIL administration is defined by the administration of NMA-LD, complete infusion of TIL therapy and at least 1 dose of interleukin-2 (IL-2).
TEAEs will determined on the Common Toxicity Criteria for Adverse Events Version 5.0 (CTCAEv5) as reported on case report forms.
To evaluate the efficacy of LN-145 as determined by objective response rate (ORR) in patients with metastatic NSCLC using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as assessed by central review for Cohorts 1 and 2 and by the investigator for Cohorts 3, 4 and the Retreatment Cohort
To evaluate the safety and tolerability of the TIL regimen that occurs from the start of TIL infusion and up to 30 days after TIL infusion per CTCAE.
| Arm | Type | Description |
|---|---|---|
| Cohort A: CSCC Autologous TIL Therapy | EXPERIMENTAL | 10 participants with CSCC will complete: * Screening visit * Surgical procedure to collect tissue, called TIL harvest * Baseline visit * Days -5 through -1: Predetermined dose of Lymphodepleting Chemotherapy, Fludarabine, 1x daily * Days -5 and -4: Predetermined dose of Lymphodepleting Chemotherapy, Cyclophosphamide, 1x daily * Day 0: TIL infusion * Days 0, 1, 2, 3, 4, and 14: Predetermined dose of IL-2 1x daily for up to 6 doses * Imaging at weeks 6 and 12 * End of treatment visit with imaging * Long term follow up every 3 months for up to 3 years |
| Cohort B: MCC Autologous TIL Therapy | EXPERIMENTAL | 4 participants with MCC will complete: * Screening visit * Surgical procedure to collect tissue, called TIL harvest * Baseline visit * Days -5 through -1: Predetermined dose of Lymphodepleting Chemotherapy, Fludarabine, 1x daily * Days -5 and -4: Predetermined dose of Lymphodepleting Chemotherapy, Cyclophosphamide, 1x daily * Day 0: TILs infusion * Days 0, 1, 2, 3, 4, and 14: Predetermined dose of IL-2 1x daily for up to 6 doses * Imaging at weeks 6 and 12 * End of treatment visit with imaging * Long term follow up every 3 months for up to 3 years |
| Cohort 1 | EXPERIMENTAL | Patients whose tumors did not express programmed cell death-ligand 1 (PD-L1), i.e., tumor proportion score (TPS) \< 1% prior to ICI treatment and Patients with no available historical TPS for PD-L1 expression |
| Cohort 2 | EXPERIMENTAL | Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment |
| Cohort 3 | EXPERIMENTAL | Patients, regardless of tumor PD-L1 TPS prior to ICI treatment, who are unable to safely undergo a surgical tumor resection for TIL generation |
| Cohort 4 | EXPERIMENTAL | Patients, regardless of tumor PD-L1 expression status prior to ICI treatment, who have meet all inclusion/exclusion criteria except the requirement to have documented disease progression may elect to have the tumor harvest procedure and TIL production prior to disease progression on their current anticancer treatment. Documentation of progressive disease and identification of a target lesion for RECIST v1.1 assessment is required at Baseline for these patients. |
| Retreatment Cohort | EXPERIMENTAL | Patients who were previously treated with LN-145 in Cohort 1, 2, 3, or 4. |
| Cohort 5 | EXPERIMENTAL | LN-145 cryopreserved/LN-145-S1 cryopreserved TIL re-treatment |
| Rhabdomyosarcoma (RMS) | EXPERIMENTAL | - |
| Ewing Sarcoma (EWS) | EXPERIMENTAL | - |
| Primary Central Nervous System Tumor | EXPERIMENTAL | - |
| Melanoma | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LN-145 | BIOLOGICAL | Autologous tumor-infiltrating lymphocytes via intravenous (into the vein) infusion per protocol |
| Cyclophosphamide | DRUG | Antineoplastic drug, multi-dose vial, per institutional standards |
| Fludarabine | DRUG | Nucleotide metabolic inhibitor, single-use vial, via intravenous infusion per institutional standards |
| Interleukin-2 | BIOLOGICAL | Recombinant, human glycoprotein, single-use vial, via intravenous infusion per protocol |
| LN-145-S1 | BIOLOGICAL | A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with autologous TIL (LN-145-S1) followed by IL-2 administration. |
| LN-145/LN-144 | BIOLOGICAL | A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. |
Inclusion Criteria: * Provide written informed consent, which includes understanding that there may be a need for intensive supportive care measures during the study and assessing willingness to undergo such measures, and written authorization for use and disclosure of protected health information....
LN-145 is an investigational tumor-infiltrating lymphocyte (TIL) therapy being studied for the treatment of squamous cell carcinoma of the head and neck, soft tissue sarcoma, metastatic non-small cell lung cancer, and cutaneous squamous cell carcinoma. It is developed by Iovance Biotherapeutics and is currently in Phase 2 clinical trials for these indications.
LN-145 is being developed by Iovance Biotherapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IOVA. The company is focused on developing novel T cell-based immunotherapies for the treatment of cancer, with LN-145 being one of its key investigational assets.
LN-145 is currently in Phase 2 clinical development for multiple oncology indications, including squamous cell carcinoma of the head and neck, metastatic non-small cell lung cancer, and cutaneous squamous cell carcinoma. It has received accelerated approval designation from the FDA, though it remains investigational and is not yet approved for commercial use.
LN-145 is being evaluated in several clinical trials, including NCT03083873 for squamous cell carcinoma of the head and neck (Phase 2, completed), NCT04614103 for metastatic non-small cell lung cancer (Phase 2, recruiting), and NCT07288073 for cutaneous squamous cell carcinoma (Phase 2, recruiting). These trials are enrolling patients across multiple countries.
Yes, LN-145 is also known as LN-145/LN-144. This alternative name is used in some clinical trial contexts to refer to the same autologous tumor-infiltrating lymphocyte therapy. Patients and researchers searching for either name will find information about the same investigational product being developed by Iovance Biotherapeutics.
LN-145 is a tumor-infiltrating lymphocyte (TIL) therapy, which involves collecting and expanding a patient's own immune cells that have infiltrated their tumor. These expanded T cells are then infused back into the patient to attack and destroy cancer cells. This approach is designed to harness the body's natural immune response against tumors.