Iovance’s Lifileucel Achieves 50% Response Rate in Advanced Soft Tissue Sarcoma Trial

IOVAIOVA

Iovance Biotherapeutics reported that one-time lifileucel infusion elicited a 50% objective response rate in advanced UPS and DDLPS patients refractory to standard therapy, marking the first TIL cell trial in these sarcoma subtypes. AMTAGVI, approved as the first FDA TIL therapy in 2024, underscores its pioneer status.

1. Trial Results in UPS and DDLPS

Iovance reported lifileucel treatment in advanced undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma patients produced a 50% objective response rate in the first clinical trial of a TIL cell therapy for these subtypes. Patients refractory to frontline standard of care—who typically see only a few months median progression-free survival and under one-year overall survival—responded to the one-time infusion of lifileucel.

2. Commercial Leadership and Next Steps

AMTAGVI, approved as the first FDA-approved tumor-infiltrating lymphocyte therapy in February 2024, established Iovance as the pioneer in this modality. Full lifileucel trial results are slated for presentation at a medical conference in 2026, potentially driving further development in soft tissue sarcomas that currently have no approved immunotherapy options.

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