Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tumor infiltrating lymphocytes (TIL) LN-145
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 autologous cell therapy developed by Iovance Biotherapeutics for patients with pretreated metastatic triple negative breast cancer. It uses a patient's own tumor infiltrating lymphocytes, expanded outside the body and returned as a treatment. It is also known as TIL LN-145.
LN-145 is being studied for use in patients with pretreated metastatic triple negative breast cancer. The Phase 2 trial NCT04111510 evaluated autologous tumor infiltrating lymphocytes in this population. It is an investigational therapy and has not been approved for this indication.
LN-145 is being developed by Iovance Biotherapeutics, Inc., which trades on the Nasdaq under the ticker IOVA. The company is the sponsor of the clinical program evaluating this autologous tumor infiltrating lymphocyte therapy in metastatic triple negative breast cancer.
LN-145 is in Phase 2 clinical development. The trial NCT04111510 was a Phase 2 study that has been completed. LN-145 remains an investigational therapy and is not approved by the FDA for any indication.
LN-145 has been evaluated in one clinical trial, NCT04111510, titled Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer. This Phase 2 trial was completed and enrolled 6 participants in the United States.
Yes, LN-145 is also known as Tumor infiltrating lymphocytes (TIL) LN-145. Both names refer to the same investigational autologous cell therapy developed by Iovance Biotherapeutics for metastatic triple negative breast cancer.