Lifileucel Shows Durable Responses in Advanced Soft Tissue Sarcoma

Patients with advanced soft tissue sarcomas have limited treatment options, particularly after progression on first-line chemotherapy. In this interview, Lauren Banks, MD, PhD, a sarcoma medical oncologist at Memorial Sloan Kettering Cancer Center, discusses research evaluating lifileucel (Amtagvi), a tumor-infiltrating lymphocyte (TIL) therapy, in patients with dedifferentiated liposarcoma (DDLPS) and undifferentiated pleomorphic sarcoma (UPS).

Sarcomas comprise numerous distinct diseases with different biological characteristics. Because these cancers are rare, clinical trials face challenges enrolling enough patients while accounting for differences among subtypes. This pilot study took a histology-driven approach, focusing on UPS and DDLPS, 2 common types of adult soft tissue sarcoma with substantial unmet medical need.¹

The study primarily evaluated feasibility and safety, including whether tumor tissue could be collected, processed to expand TILs, and reinfused into patients. The treatment process involved surgical tumor harvesting, approximately 22 days of manufacturing, lymphodepleting chemotherapy, TIL infusion, and IL-2 support.

Of 12 patients who underwent tumor harvesting, 10 received a TIL infusion, meeting the study’s feasibility objective. Eight patients received a product that met prespecified manufacturing specifications. All 10 infused patients experienced grade 4 cytopenias, which subsequently resolved. Eight patients also experienced grade 3 or higher nonhematologic toxicities, most commonly febrile neutropenia.

Efficacy was exploratory because the pilot study was not designed to establish treatment effectiveness. Among the first 8 evaluable patients who received product meeting manufacturing specifications, lifileucel produced a confirmed objective response rate of 50%, with 4 partial responses—2 in each sarcoma subtype. All 4 responses remained ongoing at the September 9, 2026, data cutoff, with durations of at least 6, 26, 40, and 46 weeks.²

These early findings support further investigation of TIL therapy in advanced UPS and DDLPS. A registrational phase 2 study, SARATOGA (NCT07741877), is evaluating lifileucel in these patient populations.²

REFERENCES

1. Banks L, et al. Lifileucel in advanced soft tissue sarcomas: pilot study feasibility, safety, and efficacy findings. Presented at: ESMO 2026; October 23-27, 2026; Madrid, Spain. Abstract 3725RO.

2. Iovance announces data showing durable responses with lifileucel TIL cell therapy in advanced soft tissue sarcomas at ESMO 2026. News release. Iovance Biotherapeutics. Accessed October 26, 2026. https://tinyurl.com/56khmvpt.