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Lifileucel · 6 trials · 15 indications
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by objective response rate (ORR) and progression-free survival (PFS) assessed by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the IRC
Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for Cohorts 1 \& 3 and as assessed by Independent Review Committee (IRC) per RECIST Version 1.1 for Cohorts 2 \& 4
Success rate of tumor infiltrating lymphocyte (TIL) expansion from all screened eligible patients who have had tumor-involved lymph node(s) removed; percentage of all eligible patients who have completed the screening and treated with LN-144/lifileucel.
The severity of AEs will be graded according to CTCAE version 5.0, and frequencies and percentages of patients with AEs will be tabulated by severity grade.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Lifileucel plus Pembrolizumab |
| Arm B | ACTIVE_COMPARATOR | Pembrolizumab alone with Optional Crossover Period |
| Lifileucel | EXPERIMENTAL | - |
| Single Arm | EXPERIMENTAL | Lifileucel |
| Patients with Endometrial Cancer | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed) |
| Cohort 2 | EXPERIMENTAL | Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) |
| Cohort 3 | EXPERIMENTAL | Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b). |
| Cohort 4 | EXPERIMENTAL | Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) |
| Treatment (pembrolizumab, lifileucel) | EXPERIMENTAL | Patients receive pembrolizumab IV on day -14, cyclophosphamide IV QD on days -7 to -6, fludarabine IV over 30 minutes QD on days -5 to -1, and lifileucel IV infusion on day 0. Patients also receive pembrolizumab IV on day 28 and 70, and undergo surgery on day 80. MAINTENANCE: Patients receive pembrolizumab IV every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Lifileucel plus Pembrolizumab | BIOLOGICAL | A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive Pembrolizumab followed by the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. Patients will then continue to receive Pembrolizumab every 6 weeks until disease progression. |
| Pembrolizumab with Optional Crossover Period | BIOLOGICAL | Patient will receive Pembrolizumab monotherapy every 6 weeks until disease progression. Upon verified confirmed disease progression by the blinded independent review central committee, patients may proceed to lifileucel monotherapy during an optional crossover period if they meet eligibility criteria. Optional crossover: A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. |
| Lifileucel | BIOLOGICAL | Study intervention will begin with a tumor resection from which lifileucel will be generated. The lifileucel regimen consists of a preparative NMA-LD regimen (ie, cyclophosphamide with mesna followed by fludarabine), the lifileucel infusion, and an abbreviated course of aldesleukin (interleukin-2). |
| Cyclophosphamide | DRUG | Given IV |
| Fludarabine | DRUG | Given IV |
| Pembrolizumab | BIOLOGICAL | Given IV |
| Therapeutic Conventional Surgery | PROCEDURE | Undergo surgery |
Inclusion Criteria: 1. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma. 2. In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an est...
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Lifileucel is an investigational tumor-infiltrating lymphocyte therapy being studied for the treatment of multiple cancers, including metastatic melanoma, locally advanced melanoma, sarcoma, and endometrial cancer. It is a cell therapy being developed by Iovance Biotherapeutics for use in oncology.
Lifileucel is a cell therapy that uses a patient's own tumor-infiltrating lymphocytes. These cells are collected from the tumor, expanded in the laboratory, and then infused back into the patient to attack cancer cells. It is being studied in combination with pembrolizumab in some trials.
Lifileucel is being developed by Iovance Biotherapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IOVA. The company is focused on developing cell therapies for cancer treatment.
Lifileucel is in Phase 2 clinical development for multiple indications. It has received FDA designations including Priority Review, Regenerative Medicine Advanced Therapy (RMAT), and Fast Track. It is not yet approved and remains investigational.
Lifileucel is being studied in several clinical trials. NCT02360579 is a completed Phase 2 trial in metastatic melanoma with 220 participants. NCT05176470 is an active Phase 1 trial in locally advanced melanoma. NCT05727904 is a recruiting Phase 3 trial in advanced melanoma with 670 participants. NCT07741877 is a planned Phase 2 trial in soft tissue sarcoma.
Lifileucel is sometimes referred to as Lifileucel plus Pembrolizumab when used in combination therapy. In clinical trials, Lifileucel is being studied both as a monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor, for the treatment of melanoma.