A one-time cell therapy already approved for skin cancer shrank tumors in half of a small group of people with two rare and aggressive sarcomas, its maker Iovance Biotherapeutics said on October 26, 20261. The results came from 8 patients in an early pilot study and were presented as a talk at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid1, a large cancer meeting held October 23 to 272. The data have not been published in a peer-reviewed journal.
What happened
The treatment is lifileucel, which Iovance sells for melanoma under the brand name Amtagvi1. It belongs to a group of treatments called TIL therapy, short for tumor-infiltrating lymphocytes: immune cells found inside a patient’s tumor1. The company describes it as a way of harnessing the immune system’s ability to recognize and destroy cancer cells3.
The study tested lifileucel alone, given once, in people with two kinds of soft tissue sarcoma that had spread: undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS)1. Soft tissue sarcomas are rare cancers made up of about 80 different subtypes1.
Among the first 8 patients who could be assessed, tumors shrank enough to count as a “confirmed response” in 4 of them, or 50%, based on the study doctors’ reading of scans using a standard scoring system called RECIST1. Two responses were in UPS and two in DDLPS1. All 4 were what doctors call partial responses, meaning the tumors shrank but did not vanish1.
The evidence so far
This is an update. In February 2026, Iovance announced that the first 6 evaluable patients in the same pilot had a 50% response rate3. The new report adds two patients and longer follow-up, and the rate stayed at 50%1.
The company’s main new point is how long the responses have lasted. As of the data cut-off on September 9, 2026, all 4 responses were still ongoing, at 6, 26, 40 and 46 weeks and counting1. Iovance also said responses deepened over time, as it has seen in melanoma and lung cancer1.
The patients were not easy cases, according to the company. All had cancer that kept growing after earlier drug treatment, with between 1 and 7 prior lines of therapy1. Their tumors were large: the combined size of the measured tumors at the start ranged from 39.0 to 177.6 millimeters1. In February, the company reported an average of 117 millimeters for the first 6 patients and an average of more than two earlier treatments3.
On safety, Iovance said only that the side effects were consistent with what is seen with lifileucel treatment in other cancers1. The announcement did not list specific side effects or how often they happened.
Lauren Banks, a sarcoma specialist at Memorial Sloan Kettering Cancer Center (MSKCC) in New York who leads the study, said in the company’s release:
“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.”1
What it does not show yet
Several limits matter here:
- Very few people. The results rest on 8 patients1. With a group this small, one or two patients more or less would change the percentage a lot.
- No comparison group. Everyone got lifileucel. The company compares its results with figures from other, earlier studies of standard second-line treatment, where tumors shrank in fewer than 5% of patients, cancer was held back for about 2 to 3 months on average, and median survival was about 9 to 10 months1. Those were different patients in different studies, so the comparison is not head to head.
- Doctors’ own readings. Responses were assessed by the study physicians1. The next, larger study will use an independent review committee to read the scans1.
- Shrinkage, not survival. The report is about tumors shrinking on scans. It does not show whether patients live longer or feel better.
- Not peer reviewed. The data come from a company announcement and a conference talk, not a published paper.
- Who could be counted. The 8 evaluable patients received lifileucel that met set manufacturing standards1. The announcement does not say how many people enrolled in total or whether any could not be treated.
Who is behind it
The pilot study is led by MSKCC and supported by Iovance3. Iovance, a publicly traded company, owns lifileucel and would earn money from any new approval1. The results here were shared through the company’s own press releases.
Iovance is open about its business goals. Brian Gastman, its executive vice president for translational medicine and research, said in the release that the company aims to “support two new approvals for lifileucel” and that sarcoma patients are concentrated at academic centers that overlap with the company’s existing sales footprint1. Banks is the principal investigator of both the pilot and the next trial1. The sources do not say whether she has financial ties to the company.
How it fits the field
Amtagvi was the first one-time treatment approved by the US Food and Drug Administration (FDA) for previously treated advanced melanoma, and the company says it is now approved in three markets and offered at nearly 100 authorized treatment centers1. Iovance describes it as the first FDA-approved T cell therapy for a solid tumor3. Biohack recently covered results for the same cells combined with Keytruda in melanoma: Own tumor immune cells plus Keytruda made melanoma vanish on scans in 29%.
Sarcoma is a hard field. Soft tissue sarcomas are diagnosed in about 4 to 5 people per 100,000 each year in Europe and about 3.5 per 100,000 in the US1. Iovance estimates that UPS and DDLPS together affect more than 3,000 patients in the US and more than 5,000 in Europe each year3. For people whose UPS or DDLPS has spread, median survival is under two years, and after first-line chemotherapy the cancer is held back for only 5 to 6 months on average, the company says1. There are no approved immunotherapy options for these patients, according to Banks1.
The FDA gave lifileucel fast track designation for advanced UPS and DDLPS in the second quarter of 2026, based on early results from this pilot1. Fast track is a status meant to speed up the review of drugs for serious conditions; it is not an approval.
What to watch next
The key test is a larger study called SARATOGA. It is a Phase 2 trial, meaning a mid-stage study, that Iovance calls “registrational,” meaning it intends to use the results to seek approval1. The registry record lists it as recruiting, with a start date of October 2, 2026, about 80 people planned, and Iovance as the sponsor4. In February, Iovance had said it planned to start this trial in the second quarter of 20263; the registry shows a later start date4.
SARATOGA enrolls adults with advanced UPS or DDLPS whose cancer kept growing after at least one round of anthracycline-based chemotherapy, a common type of chemo for sarcoma1. Like the pilot, it has no comparison group: everyone gets lifileucel4. Its main measure is the share of patients whose tumors shrink, judged by an independent review committee, and it will also track how long responses last, how long patients live without their cancer growing, overall survival and safety1. The registry lists the expected primary completion date as September 1, 20334.
Iovance also says it is looking at lifileucel in other soft tissue sarcomas that have few treatment options1. Things to watch: whether the 4 responses keep lasting, whether more patients from the pilot are reported, whether full safety details are published, and whether independent scan reviews in SARATOGA show similar results.
