Iovance Reports 50% Response Rate in Soft Tissue Sarcoma in 8 Patients
Key Facts
Iovance Biotherapeutics said its treatment lifileucel achieved a confirmed objective response rate of 50% among the first 8 evaluable patients in a pilot study of metastatic UPS and DDLPS. The assessment was based on physician review and RECIST v1.1 criteria, and all four cases were partial responses. The company said all responses were ongoing at the September 9, 2026, data cutoff. The results come from a study led by Memorial Sloan Kettering Cancer Center with company support. The data were presented at the European Society for Medical Oncology congress, held in Madrid from October 23 to 27, 2026. The result offers an early signal of the treatment's activity in these two types, but is based on only eight patients.
The four partial responses were evenly split between the two types, with two cases in UPS and two in DDLPS. Their durations at the data cutoff were 6+, 26+, 40+ and 46+ weeks. The “+” indicates that the response was still ongoing at that duration, according to the company statement. The sample included patients who had previously failed between 1 and 7 lines of systemic therapy. Baseline target tumor diameters ranged from 39.0 to 177.6 mm. Iovance said the responses emerged despite disease burden and prior treatments, while describing the safety profile as consistent with the lifileucel regimen in other indications.
The company places the results in the context of limited treatment options for these two types of metastatic sarcoma. According to clinical comparisons cited in its statement, median overall survival is less than two years, and median progression-free survival after initial chemotherapy is 5 to 6 months. Second-line options cited in recent clinical studies recorded response rates below 5%. Median progression-free survival with those options was about 2–3 months, and median overall survival about 9–10 months. These are historical comparison figures presented by the company, not the result of a direct randomized comparison between lifileucel and those treatments. The significance of the new results therefore remains tied to confirmation in a larger study.
The data target two types of soft tissue sarcoma, UPS and DDLPS, within a disease the company describes as rare and heterogeneous. The disease includes about 80 subtypes, according to its statement. The company estimates its incidence in Europe at about 4–5 cases per 100,000 people annually, compared with about 3.5 new diagnoses per 100,000 people annually in the United States. In the second quarter of 2026, lifileucel received Fast Track designation from the U.S. Food and Drug Administration for advanced UPS and DDLPS, based on preliminary results from the pilot study. The designation provides an expedited regulatory pathway, but does not mean the treatment is approved for these two types. Lifileucel remains under investigation for these sarcomas.
The pivotal Phase 2 SARATOGA trial is evaluating the safety and efficacy of lifileucel in patients with advanced, unresectable or metastatic UPS or DDLPS after resistance to anthracycline-based chemotherapy. The study carries identifier NCT07741877 and was recruiting patients at Memorial Sloan Kettering and major U.S. cancer centers. The primary endpoint is response rate under RECIST v1.1, assessed by an independent review committee. Results from the pilot study are scheduled to be presented orally on October 26, during a session from 08:30 to 10:00 Central European Summer Time. Results from the pivotal study remain the next step in assessing whether the early signal will be repeated in a broader group.
On the company front, Iovance shares closed at $14.09 on October 23, 2026, according to EL7 data. The company reported record product revenue of $99.3 million in the second quarter of 2026. It also had about 100 authorized treatment centers, with a target of reaching at least 110 by year-end. Iovance expects to report third-quarter 2026 results in early November. That puts the financial results close to investors' next update on progress in the SARATOGA trial.