Iovance Announces Data Showing Durable Responses with Lifileucel TIL Cell Therapy in Advanced Soft Tissue Sarcomas at ESMO 2026
Key Highlights
- ➤50% confirmed ORR among first eight evaluable patients with advanced UPS and DDLPS
- ➤Four partial responses remained ongoing at 6+, 26+, 40+, and 46+ weeks
- ➤SARATOGA registrational Phase 2 trial enrolling refractory UPS and DDLPS patients
- ➤FDA granted lifileucel fast track designation for advanced UPS and DDLPS in Q2 2026
Expert Statements
Brian Gastman, Executive Vice President, Translational Medicine and Research at Iovance Biotherapeutics
“The unprecedented efficacy for one-time lifileucel in UPS and DDLPS sets a new bar for response rates with TIL therapy in refractory patients and underscores the powerful potential of our TIL platform across many solid tumor cancers”
Brian Gastman, Executive Vice President, Translational Medicine and Research at Iovance Biotherapeutics
“UPS and DDLPS patients also experienced deepening responses over time, consistent with lifileucel’s responses in melanoma, non-small-cell lung cancer, and other solid tumors.”
Brian Gastman, Executive Vice President, Translational Medicine and Research at Iovance Biotherapeutics
“On the heels of this pilot trial, we are rapidly enrolling the SARATOGA registrational study to support two new approvals for lifileucel.”
Brian Gastman, Executive Vice President, Translational Medicine and Research at Iovance Biotherapeutics
“Iovance is strongly positioned to drive potential adoption in refractory UPS and DDLPS patients that are highly concentrated at academic centers that overlap with our existing commercial footprint.”
Lauren Banks, M.D., Ph.D., Sarcoma Medical Oncologist at Memorial Sloan Kettering Cancer Center and principal investigator of the pilot and SARATOGA trials of lifileucel
“Lifileucel showed encouraging response rates and lasting benefits in patients with UPS and DDLPS who are refractory to frontline standard of care.”
Lauren Banks, M.D., Ph.D., Sarcoma Medical Oncologist at Memorial Sloan Kettering Cancer Center and principal investigator of the pilot and SARATOGA trials of lifileucel
“This level of durability provides meaningful time for patients with refractory UPS and DDLPS suffering from high disease burden, poor quality of life, and a lack of effective treatments, including no approved immunotherapy options.”
50% Confirmed Objective Response Rate (ORR) with All Responses Ongoing in an Oral Presentation at the European Society for Medical Oncology (ESMO) Congress 2026
Unprecedented Efficacy in Both Refractory Undifferentiated Pleomorphic Sarcoma (UPS) and Dedifferentiated Liposarcoma (DDLPS)
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