Trial results for Lifileucel in patients with metastatic melanoma were posted on ClinicalTrials.gov on 2025-12-09. The Phase 2 study (NCT02360579) evaluated autologous tumor infiltrating lymphocytes, reporting objective responses in 25 participants in Cohort 4, with a median Duration of Response of 10.4 months in the same cohort.
Background
Lifileucel is an adoptive cell therapy (ACT) utilizing autologous tumor infiltrating lymphocytes (TIL) for the treatment of patients with metastatic melanoma. This approach involves infusing the patient's own tumor-infiltrating lymphocytes after a nonmyeloablative lymphodepletion preconditioning regimen, followed by interleukin 2 (IL-2).
Trial design
The study (NCT02360579) was a Phase 2, prospective, interventional multicenter study. It enrolled 220 participants with metastatic melanoma. The intervention involved adoptive cell therapy via infusion of lifileucel (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion preconditioning regimen. The trial did not list specific primary outcome measures in the provided data.
Key results
Key results from the study included measurements for Objective Response Rate (ORR), Duration of Response (DoR), Disease Control Rate (DCR), and Progression-Free Survival (PFS) across different cohorts.
- For Objective Response Rate:
- Cohort 1 reported 4 participants.
- Cohort 2 reported 23 participants.
- Cohort 3 reported 1 participant.
- Cohort 4 reported 25 participants.
- For Duration of Response:
- Cohort 4 showed a median of 10.4 months.
- For Disease Control Rate:
- Cohort 1 reported 12 participants.
- Cohort 2 reported 48 participants.
- Cohort 4 reported 72 participants.
- For Progression-Free Survival:
- Cohort 2 showed a median of 4.1 months.
- Cohort 4 showed a median of 3.9 months.
What this means
The results from this Phase 2 study indicate that lifileucel demonstrates clinical activity in patients with metastatic melanoma, as evidenced by objective responses and disease control rates observed across various cohorts. The median Duration of Response of 10.4 months in Cohort 4 suggests a sustained benefit for some patients. These findings contribute to the understanding of adoptive cell therapy using autologous TILs in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02360579, titled "Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma," were posted on 2025-12-09 on clinicaltrials.gov.