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Tumor infiltrating lymphocytes LN-145 · 1 trial · 1 indication
To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer (TNBC) patients by determining the objective response rate (ORR), using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the Investigator. Upon results entry, the time frame was updated to reflect the latest time point that a participant was assessed for ORR in the study.
To characterize the safety profile of tumor infiltrating lymphocytes (TIL) as a single therapy in Metastatic Triple Negative Breast Cancer patients as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs). Incidence is presented as a count of participants that experienced at least 1 TEAE of Grade ≥ 3.
| Arm | Type | Description |
|---|---|---|
| LN-145 | EXPERIMENTAL | LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer. |
| Name | Type | Description |
|---|---|---|
| Tumor infiltrating lymphocytes (TIL) LN-145 | DRUG | The TIL autologous therapy with LN-145 is comprised of the following steps: 1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product; 2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility; 3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards); 4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization); 5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization). |
Inclusion Criteria: * Ability to understand the requirements of the study. Specifically, the patient has to provide written informed consent (as evidenced by signature on an ICF approved by the Yale Human Investigation Committee (HIC). * All patients must have a triple negative metastatic breast ca...
Tumor infiltrating lymphocytes LN-145 is an investigational cell therapy being studied for the treatment of metastatic triple negative breast cancer. It is currently in Phase 2 clinical development and has not been approved by the FDA. The therapy is designed to use a patient's own tumor-infiltrating lymphocytes to target cancer cells.
Tumor infiltrating lymphocytes LN-145 is being developed by Iovance Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IOVA. The company is focused on developing novel cell therapies for cancer treatment.
Tumor infiltrating lymphocytes LN-145 is in Phase 2 clinical development for metastatic triple negative breast cancer. It is an investigational therapy, meaning it has not yet received FDA approval and is still being evaluated in clinical trials to determine its safety and effectiveness.
Tumor infiltrating lymphocytes LN-145 has been studied in one completed Phase 2 clinical trial, NCT04111510, titled 'Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer.' This single-arm, uncontrolled trial enrolled 6 participants in the United States and has been completed.
Tumor infiltrating lymphocytes LN-145 has received FDA accelerated approval designation for its investigational use in metastatic triple negative breast cancer. This designation is intended to expedite the development and review of therapies that address serious conditions and fill an unmet medical need, though the therapy remains in clinical development.