A one-time therapy made from immune cells taken out of a patient’s own tumor, given together with the widely used immune drug Keytruda, made tumors disappear on scans in 29.2% of people with advanced melanoma in a mid-stage trial1. The final results were presented at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid12. The therapy is called lifileucel and is made by Iovance Biotherapeutics2.
The patients had not yet been treated with immune drugs called checkpoint inhibitors, so this was a test of the combination as a first treatment21. Until now, lifileucel had mostly been studied and used in people whose melanoma kept growing after other drugs34.
What happened
The study, called IOV-COM-202, was a Phase 2 trial (a mid-stage test that looks at how well a treatment works before a larger comparison trial)1. Its final results were given as an oral presentation by Andrew Furness and colleagues on October 23, 202625.
According to a summary of the presentation, the reported results were1:
- 29.2% of patients had their tumors disappear on scans (a “complete response”).
- 62.5% had their tumors shrink substantially.
- The median time before the cancer grew again was 19.8 months. That means half of patients went longer than this without their cancer growing, and half did not.
- Median overall survival had not been reached after 50.9 months of follow-up. In plain terms, fewer than half of patients had died at that point.
- 13 of 15 patients whose tumors responded kept that response for at least 12 months.
Iovance’s chief medical officer, Noah Berkowitz, described the results in a company statement as showing “deep, durable responses with a single treatment of lifileucel added to pembrolizumab”2. Pembrolizumab is the generic name for Keytruda6.
How the therapy works
Inside many tumors are immune cells called tumor-infiltrating lymphocytes, or TILs. These are white blood cells that have already found their way into the cancer. TIL therapy takes these cells from a patient’s own tumor, multiplies them in a lab, and puts them back so they can attack the cancer more strongly1.
In the earlier main lifileucel trial, the cells were grown from removed tumor samples at central manufacturing sites in a 22-day process3. Before the infusion, patients got chemotherapy to clear out some of their existing immune cells, then a single infusion of lifileucel, then up to six doses of high-dose interleukin-2, an immune-boosting drug3. Keytruda works differently: it releases the “brakes” on the immune system, and it is already a standard first treatment for advanced melanoma1.
The evidence so far
The new numbers sit on top of years of data in sicker patients. In a trial published in the Journal of Clinical Oncology in 2021, 66 people with advanced melanoma who had already had an average of 3.3 earlier treatments received lifileucel alone3. Tumors shrank in 36% of them: 2 had complete responses and 22 had partial responses3. The researchers reported that side effects matched those already known from the pre-treatment chemotherapy and interleukin-23. That trial, registered as NCT02360579, eventually enrolled 220 people and was completed in 20247.
Five-year results from that earlier trial were discussed by cancer doctors in 2025. They noted that a meaningful share of people who responded at first were still responding at five years, while saying more data were still needed4. The therapy has received regulatory approval for later-stage use, and several cancer centers now offer it as standard care for patients whose melanoma grew despite checkpoint drugs4.
Separately, a Dutch trial run by the Netherlands Cancer Institute compared a different TIL product with the older immune drug ipilimumab (Yervoy) in 168 people with stage IV melanoma8. Tumors shrank in 49% of the TIL group versus 21% in the ipilimumab group9.
What it does not show yet
The new trial did not directly prove that adding the cell therapy beats Keytruda alone. The summary of results notes that Keytruda alone helps about half of advanced melanoma patients long-term1. Whether the combination does better can only be answered by comparing the two head to head.
The size of the trial is also a limit. The summary reports 15 patients whose tumors responded1, which points to a small group overall. Small trials can give percentages that move a lot when more people are added.
The sources reviewed for this article did not give side-effect figures for the combination. The results have been presented at a conference, and full details have not yet appeared in a peer-reviewed journal in the sources available.
There is also a question about timing. Analysts have pointed out that people who had already taken PD-1 drugs, the class that includes Keytruda, did less well on TIL therapy in pooled data: tumors shrank in 56% of people who had never had those drugs versus 24% of those whose cancer had not responded to them9. That pattern is one reason researchers are testing TIL therapy earlier, but it comes from comparing separate studies, not from a controlled test9.
Who is behind it
Iovance Biotherapeutics, a publicly traded company based in Philadelphia, develops and sells lifileucel2. The company sponsored the earlier main trial7 and promoted the new results in a press release ahead of the meeting2. At the same congress, Iovance also presented posters including an indirect comparison that, the company says, suggests lifileucel may roughly double four-year survival compared with standard treatments in melanoma that resisted PD-1 drugs2. Indirect comparisons use data from different groups of patients and are weaker than a direct test.
The company is also testing the therapy beyond melanoma. It presented early results in two rare soft tissue sarcomas from a pilot trial led by Memorial Sloan Kettering Cancer Center and supported by Iovance, and it has posters on lung cancer2.
How it fits the field
Melanoma has become a testing ground for therapies that use the body’s own immune system in personalized ways. At the same ESMO meeting, a custom-made mRNA vaccine given with Keytruda lowered the risk of melanoma returning or death by 42% after surgery in a large late-stage trial6; Biohack covered that result in a separate article. The two approaches target different patients: the vaccine was tested after melanoma was removed by surgery, while lifileucel was tested in advanced melanoma that could not simply be cut out61.
Some cancer doctors have argued that TIL therapy could be used earlier for patients who do not respond to checkpoint drugs, and that the order of treatments may need rethinking4. Logistics remain a challenge, since each dose has to be made from the patient’s own tumor4.
What to watch next
The key test is TILVANCE-301, a Phase 3 trial (the last big stage before a new use can be approved) that randomly assigns people with untreated advanced melanoma to lifileucel plus Keytruda or Keytruda alone2. It is already underway1. Its results will show whether the combination does better than the current standard first treatment.
Also worth following: a full journal publication of the IOV-COM-202 results with side-effect data, and the company’s registrational sarcoma trial, called SARATOGA2.
