Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lifileucel · 5 trials · 10 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 |
| 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 | A tumor sample is resected from each patient for lifileucel manufacturing. Patients will first receive the preparative non-myeloablative lymphodepletion (NMA-LD) regimen. They will then receive the lifileucel infusion, followed by an abbreviated course of aldesleukin. |
| 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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