Results from the Phase II IOV-COM-202 trial presented by Dr. Andrew Furness show that combining lifileucel TIL therapy with pembrolizumab achieved complete tumor disappearance in 29.2 percent of advanced melanoma patients. Overall, 62.5 percent experienced tumor shrinkage with a median progression-free survival of 19.8 months and no unexpected side effects. Researchers are now evaluating the combination therapy in the Phase III TILVANCE-301 trial.
Phase II IOV-COM-202 trial overview
- ▪The Phase II IOV-COM-202 trial enrolled 27 patients with advanced melanoma to test first-line lifileucel and pembrolizumab combination therapy, with 24 patients included in the main analysis.
- ▪Dr. Andrew Furness presented results from the international Phase II IOV-COM-202 trial evaluating lifileucel TIL therapy combined with pembrolizumab at the 2026 European Society for Medical Oncology Congress.
- ▪The IOV-COM-202 clinical trial evaluating first-line lifileucel and pembrolizumab combination therapy in advanced melanoma was funded by Iovance Biotherapeutics, Inc.
- ▪Patients in the IOV-COM-202 trial received chemotherapy preparation prior to receiving lifileucel cell infusion and a short course of interleukin-2 to stimulate immune cell activity.
Mechanisms of lifileucel and pembrolizumab
- ▪Lifileucel is a tumor-infiltrating lymphocyte therapy that extracts immune cells from a patient's tumor, expands them in a laboratory, and infuses them back into the bloodstream to attack cancer cells.
- ▪Pembrolizumab is an immune checkpoint inhibitor drug that blocks proteins restraining the immune system, enabling T cells to detect and attack cancer cells.
Pembrolizumab and lifileucel background
- ▪In 2024, lifileucel became the first cellular therapy approved by the U.S. FDA for solid tumors after the C-144-01 trial demonstrated a 31.4 percent response rate in pretreated patients.
- ▪Pembrolizumab is an established first-line treatment for advanced melanoma, though a significant proportion of patients do not experience long-lasting cancer control.
IOV-COM-202 efficacy and survival outcomes
- ▪Advanced melanoma patients treated with first-line lifileucel and pembrolizumab in the IOV-COM-202 trial achieved a median progression-free survival of 19.8 months.
- ▪After a median follow-up of 26.9 months in the IOV-COM-202 trial, median overall survival and median duration of response had not yet been reached.
- ▪Among 15 responding patients in the IOV-COM-202 trial, 13 maintained their response for at least 12 months, and 10 remained in complete or partial response at their most recent assessment.
- ▪In the IOV-COM-202 trial, 29.2 percent of advanced melanoma patients achieved complete tumor disappearance on scans following first-line treatment with lifileucel and pembrolizumab.
Phase III TILVANCE-301 trial evaluation
- ▪Dr. Andrew Furness serves as the UK National Chief Investigator for the Phase III TILVANCE-301 trial comparing lifileucel plus pembrolizumab against pembrolizumab alone.
- ▪Researchers are evaluating lifileucel combined with pembrolizumab versus pembrolizumab alone in advanced melanoma patients in the international Phase III TILVANCE-301 trial.
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