Our last article in this thread covered results presented on October 23 at the European Society for Medical Oncology (ESMO) Congress in Madrid, where a cell therapy grown from patients’ own tumor immune cells was given with Keytruda as a first treatment for advanced melanoma. What is new since then: three days later, on October 26, researchers presented the same therapy used alone in two rare sarcomas, a different kind of cancer that grows in soft tissue. Tumors shrank in 4 of the first 8 people who could be assessed.1
What happened
The therapy is lifileucel, sold in the US as Amtagvi. The US Food and Drug Administration (FDA) has approved it as a one-time treatment for advanced melanoma that was treated before. Using it in other settings, including sarcoma, is still experimental.2
The new results come from a pilot trial, an early, small study, led by Memorial Sloan Kettering Cancer Center in New York and supported by Iovance Biotherapeutics, the company that makes the therapy.2 It tested the treatment in two types of soft tissue sarcoma: undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS).2 The data were presented as a short oral talk on Monday, October 26.3 Lauren Banks of Memorial Sloan Kettering is listed as the lead author.4
Soft tissue sarcomas are rare cancers with about 80 subtypes. The company cites an estimated 4 to 5 cases per 100,000 people each year in Europe and about 3.5 per 100,000 in the US.1
The evidence so far
Among the first 8 people who could be evaluated, doctors judged that 4 had a confirmed response under RECIST, a standard scoring system that counts how much tumors shrink on scans. That is a response rate of 50%.1 All 4 were partial responses, meaning the tumors shrank but did not disappear: 2 in people with UPS and 2 in people with DDLPS.1
All 4 responses were still ongoing when the data were collected on September 9, 2026. At that point they had lasted at least 6, 26, 40 and 46 weeks.1
The patients were not easy cases. According to the company, their cancers had already failed between 1 and 7 earlier rounds of drug treatment, and their measured tumors added up to between 39.0 and 177.6 millimeters across.1 The company said safety was in line with what has been seen with the same treatment in other cancers.1 The release does not list specific side effects or how often they occurred.
For context, the company says people with these sarcomas whose cancer has spread typically live less than two years, and that current second-choice treatments have shrunk tumors in fewer than 5% of patients in recent studies.1 Those figures come from other studies, not from a head-to-head test against this therapy.
What it does not show yet
Eight people is a very small group. With so few patients, the 50% figure could move a lot as more people are added. There was no comparison group, so the trial cannot say whether patients live longer or feel better than they would with other treatments. The results have been presented at a meeting and described in a company press release, not published in full in a reviewed journal.1
The press release calls the efficacy “unprecedented.”1 That is the company’s description. Judging how these results compare with other options will need larger trials and independent review.
Who is behind it
Iovance, based in Pennsylvania, makes and sells the therapy and runs its own central manufacturing in the US.2 The sarcoma pilot was led by Memorial Sloan Kettering with Iovance’s support.2 Banks, the Memorial Sloan Kettering cancer doctor, is the principal investigator of both the pilot and the larger follow-up trial.1
She said in the company’s release:
“Lifileucel showed encouraging response rates and lasting benefits in patients with UPS and DDLPS who are refractory to frontline standard of care.”
Brian Gastman, an Iovance executive, said the company is “rapidly enrolling” the follow-up study “to support two new approvals for lifileucel.”1 The FDA granted the therapy fast track designation for these two sarcomas in the second quarter of 2026, based on early results from the pilot.1 Fast track is a program meant to speed up the FDA’s review of drugs for serious conditions; it is not an approval.
How it fits with the melanoma results
The melanoma study presented on October 23 tested a different use: the cell therapy plus Keytruda (pembrolizumab) as a first treatment for advanced melanoma. In 24 treated patients, the reported response rate was 62.5%, tumors disappeared on scans in 29.2%, and the disease was held in check in 83.3%.5 Those figures come from that same October 23 presentation, which our earlier article covered.
The sarcoma data are a separate test, in a different cancer, with the therapy given alone. Iovance presented five abstracts at the meeting, including work in lung cancer and indirect comparisons in melanoma that the company says suggest better survival than standard care. Those comparisons were not head-to-head trials.2
An investor analysis published October 28 noted that expanding into more cancers would also put more demand on Iovance’s manufacturing. It described the company’s biggest risk as heavy reliance on a single complex, high-cost platform.5 Each dose is made individually from a patient’s own tumor.
What to watch next
The larger sarcoma trial, called SARATOGA, is recruiting. Its public registry record lists Iovance as sponsor, a start date of October 2, 2026, and a target of about 80 participants. Its main measure is how often tumors shrink, and it lists September 2033 as the expected date for main results.6 The company says the trial is enrolling at Memorial Sloan Kettering and other major US cancer centers, and that responses will be judged by an independent review committee.1
The sources describe the entry rules slightly differently. Iovance’s October 26 release says patients must have had at least one earlier round of anthracycline-based chemotherapy, a common type of chemotherapy.1 Its October 19 release says at least one earlier round of any drug treatment.3
For melanoma, the larger comparison trial TILVANCE-301 is still running. It compares the cell therapy plus Keytruda with Keytruda alone in about 670 people with untreated advanced melanoma, with main results expected around March 2028.7
