Interim Phase 2 IOV-LUNG-202 Data Show Lifileucel’s Potential Treating Advanced NSCLC

Interim data from the phase 2 IOV-LUN-202 clinical trial (NCT04614103) demonstrates that lifileucel (Iovance Biotherapeutics) monotherapy has benefits in patients with previously treated advanced nonsquamous non–small cell lung cancer (NSCLC) without actionable genetic mutations. Further data from the trial is slated to be presented at an upcoming medical meeting in 2026, according to a news release from the manufacturer.^1,2

Lifileucel is a tumor-infiltrating lymphocyte (TIL) cell therapy. TIL cells are naturally occurring immune cells that constantly monitor, recognize, attack, and kill cancer cells in patients’ bodies. They recognize cancer by tumor markers on the surface of cancer cells, which are unique to each person. When TIL cells are unable to perform their intended function, cancer invades the body.

TIL cell therapy is intended to reinvigorate and expand a patient’s TIL cells, allowing them to be deployed to fight cancer. To achieve this, a patient’s naturally occurring TIL cells are collected from a portion of their own tumor and grown outside the body. Individualized TIL therapy is a 1-time treatment to deliver these cells back to the patient.¹

“It is exciting to see such an impressive response rate and durability observed in previously treated patients with NSCLC, because today there are only very limited treatment options, none of which demonstrate this quality of response and durability,” Martin Wermke, MD, professor for experimental cancer therapy and director at the National Center for Tumor Diseases Dresden, said in a news release. “One-time treatment with lifileucel monotherapy has the potential to benefit many patients with advanced NSCLC following initial treatment with an immune checkpoint inhibitor.”¹

IOV-LUN-202 is a global, nonrandomized, open-label, multi-cohort, prospective phase 2 clinical trial enrolling patients with metastatic NSCLC whose disease has progressed while on chemotherapy. Patients all received lifileucel but were sorted into groups based on their PD-L1 levels: group 1 includes patients with PD-L1 levels below 1% prior to immunotherapy; group 2 includes patients with PD-L1 levels over 1% prior to immunotherapy; and group 3 includes patients, regardless of PD-L1 level, who are unable to undergo a surgical procedure to obtain TIL but can tolerate a core biopsy procedure.^2,3

The interim data show that the objective response rate (ORR) was approximately 25.6% following 1-time treatment with lifileucel monotherapy in patients with advanced nonsquamous NSCLC. An objective response was observed in 10 out of 39 patients, including 2 complete responses, 7 partial responses (PRs), and 1 unconfirmed PR (pending confirmatory assessment), with a disease control rate of approximately 71.8%. The median duration of response (mDOR) was not reached after a median follow-up of 25.4 months.¹

The safety profile for the lifileucel treatment regimen was consistent with the underlying disease, nonmyeloablative lymphodepletion (NMA-LD), and IL-2, according to the news release. Improvements in the overall safety profile without affecting efficacy, following the introduction of an updated regimen of reduced NMA-LD for IOV-LUN-202. Patients who were treated with the updated regimen showed a reduction of median post-IL-2 hospitalization days by more than half and lower incidence and shorter time to resolution of cytopenias compared with the initial regimen.¹

Following initial treatment with an immune checkpoint inhibitor and chemotherapy, patients with advanced NSCLC have limited treatment options and often receive chemotherapy, which has limited durability, wrote the manufacturers. Standard of care docetaxel monotherapy in patients with nonsquamous NSCLC previously treated with immune checkpoint inhibitors and chemotherapy has recently shown an ORR of about 12.8% with an mDOR of 5.6 months and overall survival of 12.3 months, without any complete responses. These interim data show lifileucel’s potential when improving outcomes in patients with advanced nonsquamous NSCLC.¹

“Lifileucel has demonstrated a potentially best-in-class clinical profile in previously treated advanced nonsquamous NSCLC. The duration of response is unprecedented and is combined with an impressive response rate in a 1-time monotherapy for a difficult-to-treat patient population,” Friedrich Graf Finckenstein, MD, chief medical officer of Iovance, said in the news release. “We will pursue regulatory approvals for lifileucel monotherapy to effectively address the tens of thousands of patients with previously treated nonsquamous advanced NSCLC.”¹

REFERENCES

1. GlobeNewswire. Iovance Biotherapeutics Reports Potential Best-in-Class Clinical Data for Lifileucel TIL Cell Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC). News release. November 3, 2025. Accessed November 5, 2025. https://www.globenewswire.com/news-release/2025/11/03/3179067/0/en/Iovance-Biotherapeutics-Reports-Potential-Best-in-Class-Clinical-Data-for-Lifileucel-TIL-Cell-Therapy-in-Advanced-Non-Small-Cell-Lung-Cancer-NSCLC.html

2. Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer. ClinicalTrials.gov identifier: NCT04614103. Updated June 26, 2025. Accessed November 5, 2025. https://www.clinicaltrials.gov/study/NCT04614103

3. Iovance Biotherapeutics. About the IOV-LUN-202 trial. Accessed November 5, 2025. https://www.tilcelltherapy.com/clinical-trials/iov-lun-202-non-small-cell-lung-cancer-nsclc/