Evidence map›Paper›PMID 40454684›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte Cell Therapy in Patients With Advanced Melanoma: A 5-Year Analysis of the C-144-01 Study.

Theresa Medina, Jason A Chesney, Harriet M Kluger, Omid Hamid, Eric D Whitman, Mike Cusnir, Sajeve S Thomas, Martin Wermke, Evidio Domingo-Musibay, Giao Q Phan and 10 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02360579 (A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes), which is not on this map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02360579 phase2completednot on this map

A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

TypeinterventionalSponsorIovance Biotherapeutics, Inc.Ran2015 to 2024Enrolled220ConditionsMetastatic MelanomaArmsLifileucel
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  16. Observational
  17. Article
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  19. Cellular immunotherapy in melanoma: the next frontier in cancer treatment.Journal of experimental & clinical cancer research : CR · 2026
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Theresa MedinaUniversity of Colorado Cancer Center-Anschutz Medical Campus, Aurora, CO.ORCID 0000-0003-0579-4121
Jason A ChesneyBrown Cancer Center, Louisville, KY.ORCID 0000-0003-0217-8278
Harriet M KlugerYale Cancer Center, New Haven, CT.ORCID 0000-0002-4932-9873
Omid HamidThe Angeles Clinic and Research Institute, a Cedars Sinai Affiliate, Los Angeles, CA.ORCID 0000-0002-8238-4655
Eric D WhitmanAtlantic Health System, Morristown, NJ.ORCID 0000-0001-7529-067X
Mike CusnirMount Sinai Medical Center, Miami Beach, FL.ORCID 0000-0002-5983-980X
Sajeve S ThomasAdventHealth Orlando, Orlando, FL.ORCID 0000-0002-0925-3325
Martin WermkeTechnical University Dresden-NCT/UCC Early Clinical Trial Unit, Dresden, Germany.ORCID 0000-0002-4844-4087
Evidio Domingo-MusibayAllina Health Cancer Institute, Minneapolis, MN.ORCID 0000-0002-2082-554X
Giao Q PhanUConn Health/Neag Cancer Center, Farmington, CT.ORCID 0009-0006-1258-5861
John M KirkwoodUPMC Hillman Cancer Center, Pittsburgh, PA.ORCID 0000-0002-3570-4476
James LarkinThe Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom.ORCID 0000-0001-5569-9523
Jeffrey WeberLaura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY.
Friedrich Graf FinckensteinIovance Biotherapeutics, Inc, San Carlos, CA.ORCID 0009-0009-6251-6903
Jeffrey ChouIovance Biotherapeutics, Inc, San Carlos, CA.ORCID 0000-0001-9232-0092
Brian GastmanIovance Biotherapeutics, Inc, San Carlos, CA.
Xiao WuIovance Biotherapeutics, Inc, San Carlos, CA.
Rana FiazIovance Biotherapeutics, Inc, San Carlos, CA.ORCID 0009-0003-9702-0736
Amod A SarnaikH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.ORCID 0000-0002-2337-5898
C-144-01 Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with advanced melanoma resistant to immune checkpoint or BRAF/MEK inhibitors have treatment options with relatively low efficacy. Lifileucel, a one-time autologous tumor-infiltrating lymphocyte cell therapy, was approved in the United States on the basis of the pivotal C-144-01 study. A 5-year follow-up of the C-144-01 trial assessed the long-term efficacy and safety of lifileucel. At the cutoff date (November 20, 2024), the objective response rate was 31.4% (complete response [CR], 5.9%; partial response [PR], 25.5%). Overall, 79.3% of patients had tumor burden reduction; 16 had deepened responses with four converting from PR to CR > 1 year after lifileucel infusion; 31.3% of responders completed the 5-year assessment with ongoing responses. The median duration of response was 36.5 months. Responders (n = 48) had lower tumor burden and fewer liver or brain metastases than the overall population. The median overall survival (OS) was 13.9 months, with a 5-year OS of 19.7%. Adverse events were consistent with nonmyeloablative lymphodepletion and interleukin-2 safety profiles and declined rapidly within 2 weeks after lifileucel infusion. Most grade 3/4 cytopenias resolved to grade ≤2 by day 30. This 5-year analysis demonstrated long-term benefit and meaningful OS with one-time lifileucel therapy, with no additional long-term safety concerns.

Indexed as

Immunotherapy, AdoptiveLymphocytes, Tumor-InfiltratingMelanomaSkin NeoplasmsAdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle Agedlifileucel

Identifiers

PMID40454684
PMCPMC12622280

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.