On February 24, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported positive early data from a pilot clinical trial led by Memorial Sloan Kettering Cancer Center (MSKCC) and supported by Iovance of lifileucel in patients with advanced (metastatic or unresectable) undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy.

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Among the first six evaluable patients treated with lifileucel monotherapy, physician-assessed confirmed ORR by RECIST v1.1 was 50%. All evaluable patients had advanced disease, were refractory to prior therapy, and had significant disease burden, with a mean sum of diameters of 117 millimeters at baseline and a mean of more than two prior lines of therapy. Patients experienced deep responses that improved over time, consistent with lifileucel in melanoma, non-small-cell lung cancer, and other solid tumors. The safety profile was favorable and consistent with lifileucel therapy in other indications. Based on these results, Iovance plans to commence a single arm registrational trial in second-line advanced UPS and DDLPS in the second quarter of 2026 and will engage with the U.S. Food and Drug Administration (FDA) on an accelerated path to expedite approval. Iovance also plans to explore lifileucel in other high grade soft tissue sarcoma subtypes with high unmet need as part of its clinical development program.

UPS and DDLPS are high grade, aggressive soft tissue sarcomas associated with poor prognosis that impact more than 3,000 patients in the U.S. and more than 5,000 patients in Europe annually, including more than 3,500 patients with advanced disease.1-3 There is a high unmet medical need for new treatment options for second-line patients with recent clinical studies reporting ORRs of less than 5%, median progression-free survival (mPFS) of ~2-3 months, and median overall survival (mOS) of ~9-10 months.4-6

Lauren Baker Banks, MD, PhD, Sarcoma Medical Oncologist, MSKCC, stated, "In the first clinical trial of a TIL cell therapy in UPS and DDLPS, one-time treatment with lifileucel demonstrated compelling and unprecedented response rates with the potential to address a significant unmet need in patients who are refractory to frontline standard of care. Patients with UPS and DDLPS suffer from high disease burden, poor quality of life, and a lack of effective treatments, including no approved immunotherapy options. In the second-line setting, mPFS for many patients is only a few months with mOS less than a year. We look forward to presenting these results at a medical conference in 2026."

Dr. Brian Gastman, EVP Translational Medicine and Research at Iovance, stated, "The exciting clinical results show that lifileucel could offer a new, highly efficacious, and durable immunotherapy option in two aggressive forms of advanced sarcoma and further illustrate the promise of our TIL cell therapy platform to offer meaningful clinical benefit in multiple solid tumor cancers. Chemotherapy with extremely poor efficacy remains the second-line standard of care for these patients after progression on front-line chemotherapy. We look forward to bringing lifileucel to UPS and DDPLS patients as quickly as possible."

(Press release, Iovance Biotherapeutics, FEB 24, 2026, View Source [SID1234662917])