TIL Therapy for Cancer
Iovance Biotherapeutics received FDA Fast Track designation for its lifileucel (TIL) therapy in non-small cell lung cancer on February 26, 2026, expanding its potential applications beyond sarcomas and melanoma. As of February 26, 2026, Iovance is planning a registrational trial for lifileucel in soft tissue sarcomas, following positive early pilot data showing a 50% confirmed objective response rate in early evaluable patients. The company reported approximately $220 million in Amtagvi sales in the U.S. for 2025, and Ochsner MD Anderson Cancer Center has begun offering TIL therapy for advanced melanoma. Vanderbilt-Ingram Cancer Center also treated its first patient in a new TIL therapy program on February 18, 2026. Retrospective analysis of lifileucel in advanced melanoma patients shows an objective response rate of 44% and a disease control rate of 73%, exceeding the 31% ORR from its accelerated FDA approval trial.
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Track this story2026
7 updates
2026
7 updatesIovance Biotherapeutics has received FDA Fast Track designation for its lifileucel (TIL) therapy in non-small cell lung cancer. This designation expands the potential applications of lifileucel beyond its current focus on sarcomas and melanoma. The company is also planning a registrational trial for lifileucel in soft tissue sarcomas.
Iovance Biotherapeutics announced positive early pilot data for lifileucel (Amtagvi) in soft tissue sarcomas, showing a 50% confirmed objective response rate in early evaluable patients. Ochsner MD Anderson Cancer Center has also begun offering TIL therapy for advanced melanoma. Iovance reported approximately $220 million in Amtagvi sales in the U.S. for 2025.
Iovance Biotherapeutics announced positive early data from a pilot clinical trial of lifileucel (TIL cell therapy) in patients with advanced undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS). The trial, supported by Iovance and led by Memorial Sloan Kettering Cancer Center, showed compelling response rates in patients refractory to frontline treatments. Iovance plans to initiate a registrational trial in the second quarter of 2026.
Iovance Biotherapeutics announced positive results from its first clinical trial of lifileucel (Amtagvi) TIL cell therapy in patients with advanced soft tissue sarcomas. The trial showed compelling response rates, demonstrating potential to address a significant unmet need in patients refractory to frontline treatments. Iovance plans to initiate a registrational trial in the second quarter.
Vanderbilt-Ingram Cancer Center has treated its first patient in a newly launched tumor-infiltrating lymphocyte (TIL) therapy program. This personalized treatment involves isolating, expanding, and re-infusing a patient's own white blood cells to fight tumors. The therapy is currently approved and marks a new institutional application of TIL therapy for melanoma.
Retrospective analysis of lifileucel (Amtagvi) therapy in advanced melanoma patients shows an objective response rate (ORR) of 44% and a disease control rate (DCR) of 73%. These real-world data exceed the ORR of 31% from the clinical trial that supported its accelerated FDA approval. A separate study also indicates that while a portion of referred patients proceed to TIL therapy, those who receive it show improved overall survival.
The Israel Cancer Research Fund and the Cancer Research Institute awarded Dr. Asaf Madi a new grant to research refining tumor-infiltrating lymphocyte (TIL) therapy, focusing on predicting patient responses and overcoming drug resistance in melanoma.
2025
6 updates
2025
6 updatesLifileucel, an FDA-approved personalized immunotherapy for advanced melanoma, is currently undergoing a review process with the National Institute for Health and Care Excellence (NICE) in the UK.
Further discussion on next-generation engineered TILs, including CRISPR gene editing and IL-2 toxicity elimination, highlights ongoing innovation in the field.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
The 2025 ASCO Annual Meeting showcases significant advancements in TIL therapy, including novel monotherapies (e.g., LM103, OBX-115, GT101, GT300, GT201, HS-IT101) and combination regimens for various solid tumors.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
The American Cancer Society provides an overview of TIL therapy, explaining how it uses a patient's own immune cells to fight cancer and its potential benefits, including long-lasting responses.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
Five-year follow-up trial results for Lifileucel are published, providing further long-term efficacy data for the approved therapy.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
MedStar Georgetown University Hospital is now offering breakthrough Tumor-Infiltrating Lymphocyte (TIL) therapy for metastatic melanoma patients who have not responded to previous treatments. This marks a new phase in the therapy's availability to patients.
2024
8 updates
2024
8 updatesLifileucel is formally incorporated into the 2024 NCCN Guidelines as a preferred second-line regimen for advanced melanoma, solidifying its place in standard oncology practice.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
Dr. Allison Betof Warner discusses TIL therapy for advanced melanoma, highlighting its potential to overcome resistance to other therapies and its role in the future of melanoma care.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
An industry insight report discusses the FDA approval of Lifileucel, the expanding pipeline of over 75 TIL-based therapies, and more than 100 clinical trials globally, projecting significant market growth.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
An article details the 30+ year journey of TIL therapy, from its discovery to the recent FDA approval of Lifileucel, and discusses ongoing research to enhance its efficacy and expand applications.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
Stanford Cancer Institute highlights the promise of TIL therapy, noting its potential for a wide array of solid tumors beyond melanoma and the significant advancements in the past 5-10 years that made it a viable treatment option.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
Stanford Cancer Institute performs the world's first commercially approved infusion of Lifileucel for advanced melanoma, marking its entry into routine clinical practice.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
The National Cancer Institute publishes a blog post detailing the historic FDA approval of Lifileucel (Amtagvi), emphasizing its significance after decades of research.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
The FDA grants accelerated approval to Lifileucel (Amtagvi) for the treatment of unresectable or metastatic melanoma in patients previously treated with other therapies, marking the first FDA-approved TIL therapy and the first cell-based immunotherapy for a solid tumor.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2023
2 updates
2023
2 updatesResearchers report that nearly 50% of patients treated with investigational Lifileucel were alive four years post-treatment, with the median duration of response not yet reached, indicating potential for long-term benefits.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
A report highlights that TIL therapy shows significantly longer progression-free survival in stage IIIC and IV melanoma patients compared to current recommended therapies, with some studies reporting a 50% overall response rate.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2022
1 update
2022
1 updateStudies show TIL therapy to be effective against metastatic melanomas that are refractory to prior treatments, yielding superior outcomes compared to ipilimumab.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2021
1 update
2021
1 updateIovance Biotherapeutics successfully conducts Phase II trials (LN-144) for Lifileucel in advanced melanoma patients who have progressed after immune checkpoint inhibitor treatment, demonstrating an 80% disease control rate.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2020
1 update
2020
1 updateRosenberg and colleagues identify a specific subset of TILs, known as stem-like lymphocytes, as being responsible for antitumor activity, enhancing understanding of TIL efficacy.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2017
1 update
2017
1 updateTIL therapy is reported to be successful in treating uveal melanoma, a rare and refractory form of the disease.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2011
1 update
2011
1 updateThe National Cancer Institute enters a cooperative research agreement with Iovance Biotherapeutics to advance the development of TIL therapy, including larger clinical trials and manufacturing infrastructure.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2009
1 update
2009
1 updateMoffitt Cancer Center becomes the first institution outside the NCI to offer TIL therapy to melanoma patients, adopting the NCI protocol.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
2000
2 updates
2000
2 updatesA simplified method for culturing TILs is developed, helping to keep the cells active for longer and improving the therapy's practicality.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
Researchers discover that lymphodepleting chemotherapy prior to TIL infusion significantly increases response rates, leading to a 56% response rate in heavily treated metastatic melanoma patients.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
1994
1 update
1994
1 updateFinal results from an expanded clinical trial involving 86 metastatic melanoma patients treated with TILs are published, showing a 34% response rate.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
1988
1 update
1988
1 updateThe first experimental use of TIL therapy in humans begins, with Rosenberg and colleagues treating 20 patients with metastatic melanoma, showing promising preliminary results of tumor regressions.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
1986
1 update
1986
1 updateDr. Steven Rosenberg and colleagues at the National Cancer Institute (NCI) discover tumor-infiltrating lymphocytes (TILs) in human tumors and develop a protocol to expand them in the lab, demonstrating their ability to cause tumor regression in mice.
via aacr.org·globenewswire.com·pmc.ncbi.nlm.nih.gov·pmc.ncbi.nlm.nih.gov
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