Cell therapy from patients' own tumors shrank lung cancer in 1 in 4, maker says

Iovance Biotherapeutics said on October 29 that its cell therapy lifileucel shrank or cleared tumors in 17 of 69 people with advanced lung cancer, a response rate of 24.6%¹. All of them had a form called non-squamous non-small-cell lung cancer that had kept growing after both chemotherapy and immunotherapy drugs¹. In a smaller group of 22 patients, picked out by the company after the results came in, the rate was 59.1%¹.

Investors did not take the update well. In 15-minute delayed market data on the day of the announcement, Iovance shares traded 35.48% below the previous close, at $9.55, on trading volume about 8.3 times the usual level².

What happened

Lifileucel is a tumor-infiltrating lymphocyte therapy, or TIL therapy: it uses immune cells taken from inside a patient’s own tumor¹³. The cells are grown in large numbers in a lab and given back as a single infusion⁴⁵. Before the infusion, patients receive a preparatory treatment called lymphodepletion, which clears out some of their existing immune cells, and afterward a drug called IL-2 to help the new cells grow⁵.

The new numbers come from a mid-stage (Phase 2) trial called IOV-LUN-202¹. The update adds 30 more patients to an earlier report, bringing the total to 69, with data counted up to October 14, 2026¹. The earlier report, in 39 patients, had shown a 25.6% response rate, so the company described the new figure as consistent with it¹.

The evidence so far

A “response” here means a tumor that shrank by a set amount or disappeared on scans². Of the 17 responses, 15 were confirmed and 2 were partial responses still waiting for confirmation on a later scan¹. Two patients had a complete response, meaning no visible tumor remained¹.

Iovance said the length of responses and the side effects were in line with what it had reported before¹. It also said a newer, lower-dose version of the preparatory treatment had improved the overall safety profile¹. The press release does not give side-effect numbers or how long responses lasted¹.

Which patients responded most

The company looked back at patients’ tumor gene tests to understand why some responded and others did not¹. The biggest split was a gene called KRAS, which is often altered in lung cancer¹:

• Patients whose tumors had a normal KRAS gene: 13 of 30 responded (43.3%)¹.
• Patients whose tumors had a mutated KRAS gene: 4 of 35 responded (11.4%)¹.
• Normal KRAS plus a normal HER2 gene: 13 of 25 responded (52.0%)¹.
• Normal KRAS, normal HER2 and a current or past smoker: 13 of 22 responded (59.1%), including both complete responses¹.

That last group made up 31.9% of patients but accounted for 76.5% of the responses¹. Four patients whose KRAS status was not checked were left out of these comparisons¹.

Iovance offered a biological reason for the pattern. It cited lab and animal studies linking KRAS activity to tumors that hide from the immune system, and research suggesting that abnormal HER2 signaling can dampen immune attack¹. It said smoking-related mutations may give immune cells more targets to recognize¹. These ideas come from earlier preclinical research, not from this trial¹.

What it does not show yet

The results come from a company press release and have not been published in a peer-reviewed journal¹. An independent committee is still reviewing patients’ scans¹, so the final count could change.

The trial has no comparison group, so it cannot show whether lifileucel helps people live longer than other treatments would. The press release reports response rates, not survival¹.

The 59.1% figure needs the most caution. Patients were enrolled without being selected by these gene and smoking criteria; the subgroup was defined after looking at the results¹. Analyses done this way can find patterns that do not hold up in new patients, and the company’s own plan is to test the selection forward in time²¹. The subgroup also has only 22 people¹.

Iovance also mentioned a separate, earlier-stage result: in another study, 6 of 7 patients who had not yet been treated for their lung cancer, had normal KRAS and a smoking history, and received lifileucel with the immunotherapy drug pembrolizumab (Keytruda) responded². That group was seven people, and their HER2 status was not checked².

Who is behind it

Iovance, based in Philadelphia, develops and sells TIL therapies and sponsored the trial¹. All of the new lung cancer numbers come from the company. Stock Titan’s coverage summarized the same release and added the market data².

The approach builds on more than 35 years of research led by Steven A. Rosenberg and his team at the US National Cancer Institute⁵.

How it fits the field

Lifileucel is already on the market for skin cancer. The FDA gave it accelerated approval on February 16, 2024, under the brand name Amtagvi, for advanced melanoma⁵. In the study behind that approval, tumors shrank in 31.5% of 73 patients who got the recommended dose⁵. Iovance’s main melanoma trial, which enrolled 220 people, has since been completed⁶.

Lung cancer has been tested before. An earlier mid-stage study, published in the journal Cancer Discovery, gave lifileucel to 28 heavily pretreated patients with advanced non-small-cell lung cancer and reported a response rate of 21.4%³. In that study, side effects were described as generally expected and manageable, but two patients died from side effects during treatment, one from heart failure and one from multiple organ failure³. The study’s authors called the results encouraging and worth further study³.

Outside Iovance, researchers are working on ways to pick out the most tumor-reactive cells before infusion. Alena Gros of the Vall d’Hebron Institute of Oncology in Barcelona has said that many patients now receive TIL products with “a fairly unknown frequency of tumor-reactive TIL” and that this could be improved⁵.

What to watch next

• Final trial numbers. The two main groups of the trial are finishing enrollment, with about 80 patients expected in the final dataset¹.
• An approval filing. Iovance plans to ask the FDA in 2027 to extend lifileucel’s approval to this type of lung cancer, and says talks with the agency are ongoing¹.
• Testing the selection in new patients. A new group within the same trial, called POSITILITY, is to start enrolling only patients who meet the gene and smoking criteria in November 2026¹. Whether it could support approval depends on FDA feedback².
• First-line treatment. The company plans a separate trial, OPTILISM, in 2027 to test lifileucel as a first treatment in selected patients².