Iovance Biotherapeutics Reports Potential Best-in-Class Clinical Data for Lifileucel TIL Cell Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC)
26% Objective Response Rate
Median Duration of Response Not Reached after 25 Months Follow Up
Lifileucel Launch in Previously Treated Advanced NSCLC Expected in Second Half of 2027
SAN CARLOS, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced interim data from its registrational Phase 2 IOV-LUN-202 trial of lifileucel monotherapy in patients with previously treated advanced nonsquamous NSCLC without actionable genetic mutations.
The objective response rate (ORR) was 25.6% by RECIST v1.1 following one-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 71.8%.1 The median duration of response (mDOR) was not reached after a median follow up of 25.4 months.
Iovance will present additional data from the IOV-LUN-202 trial at an upcoming medical meeting in 2026. The U.S. Food and Drug Administration (FDA) previously provided positive regulatory feedback on the IOV-LUN-202 trial design and the proposed potency assay matrix to support registration. This trial design aligns with FDA guidance for single-arm trials to support accelerated approvals in conditions with unmet medical need. The IOV-LUN-202 trial is expected to progress in 2026 towards a supplemental Biologics License Application for lifileucel in nonsquamous NSCLC and a potential launch in the second half of 2027.
"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," said Martin Wermke, M.D., Professor for Experimental Cancer Therapy and Director at the National Center for Tumor Diseases Dresden. "One-time treatment with lifileucel monotherapy has the potential to benefit many patients with advanced NSCLC following initial treatment with an immune checkpoint inhibitor."
Following initial treatment with immune checkpoint inhibitor and chemotherapy, patients with advanced NSCLC have limited treatment options and often receive chemotherapy, which has limited durability. Standard-of-care docetaxel monotherapy in patients with nonsquamous NSCLC previously treated with immune checkpoint inhibitors and chemotherapy has recently shown an ORR of 12.8% with an mDOR of 5.6 months and overall survival of 12.3 months, without any complete responses.2
The safety profile for the lifileucel treatment regimen was consistent with the underlying disease, non-myeloablative lymphodepletion (NMA-LD), and interleukin-2 (IL-2). Improvements in the overall safety profile have been observed, without affecting efficacy, following the introduction of an updated regimen of reduced NMA-LD for IOV-LUN-202. Patients 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.
"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 one-time monotherapy for a difficult-to-treat patient population," stated Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance. "We will pursue regulatory approvals for lifileucel monotherapy to effectively address the tens of thousands of patients with previously treated nonsquamous advanced NSCLC."
Additional details on the interim data for IOV-LUN-202 are available here: https://ir.iovance.com/news-events/events-presentations.
About Non-Small Cell Lung Cancer
Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death worldwide, with an estimated 2.5 million new cases and 1.8 million deaths globally each year, and an estimated 226,000 new cases and 125,000 deaths in the U.S. each year.3,4 Approximately 85% of lung cancer cases are NSCLC, with non-squamous NSCLC representing an estimated 75% of NSCLC cases.4
About IOV-LUN-202
IOV-LUN-202 is a registrational, global phase 2 study investigating lifileucel monotherapy in patients with advanced (metastatic or unresectable) NSCLC without EGFR, ROS1 or ALK actionable genetic mutations and previously treated with an immune checkpoint inhibitor and chemotherapy. Enrollment is expected to be completed during the second half of 2026.
About TIL Cell Therapy
Tumor infiltrating lymphocytes (TIL) are naturally occurring immune cells that are on constant surveillance to recognize, attack and kill cancer cells. TIL cells recognize cancer through tumor markers on the surface of cancer cells that are unique to each person. The majority of solid tumor immune targets are patient-specific, with fewer than 1% shared among patients. When cancer invades and prevails, the TIL cells are unable to perform their intended function. Cancer can then evade the immune system, exhausting the TIL cells and rendering them ineffective.
TIL cell therapy is intended to reinvigorate and expand a patient's TIL cells so they can be deployed to fight cancer. A patient's naturally occurring TIL cells are collected from a portion of their own tumor and grown outside the body using Iovance's proprietary manufacturing process. Individualized TIL therapy is a one-time treatment to deliver these cells back to the patient. Once inside the body, TIL cell therapy deploys billions of personalized, patient-specific TIL cells to recognize, target, and destroy diverse cancer cells.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance's Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Amtagvi ® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
References
- Interim data cut as of October 10, 2025 of nonsquamous NSCLC patients with minimum cell dose based on FDA feedback.
- Ahn MJ et al. J Clin Onc 2024;43:260-272.
- World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022.
- National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2025 Estimates, Lung and Bronchus.
Forward-Looking Statements
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