Evidence map›Paper›PMID 33979178›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma.

Amod A Sarnaik, Omid Hamid, Nikhil I Khushalani, Karl D Lewis, Theresa Medina, Harriet M Kluger, Sajeve S Thomas, Evidio Domingo-Musibay, Anna C Pavlick, Eric D Whitman and 17 more

Erratum issuedOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 295 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
295citing papers in PubMed, 2 pooled it
21.7field-weighted citation impact, top 1% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

295 citing papers in PubMed, 2 syntheses or guidelines pooled it, 382 citations in OpenAlex.

  1. Pooled it
  2. Cutaneous melanoma: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up.Annals of oncology : official journal of the European Society for Medical Oncology · 2025
    Guideline
  3. Trial
  4. RP1 Combined With Nivolumab in Advanced Anti-PD-1-Failed Melanoma (IGNYTE).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  5. Trial
  6. Trial
  7. Safety and Tolerability of Letetresgene Autoleucel (GSK3377794): Pilot Studies in Patients with Advanced Non-Small Cell Lung Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  8. Trial
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Cardiotoxicity of T cell immunotherapies.Nature reviews. Cardiology · 2026
    Review
  18. Adoptive cell therapy in lung cancer: progress, challenges, and prospects.Chinese medical journal pulmonary and critical care medicine · 2026
    Review
  19. Article
  20. Article

235 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 16 institutions in 4 countries.

Amod A SarnaikH. Lee Moffitt Cancer Center, Tampa, FL.ORCID 0000-0002-2337-5898
Omid HamidThe Angeles Clinic and Research Institute, A Cedars Sinai Affiliate, Los Angeles, CA.ORCID 0000-0002-8238-4655
Nikhil I KhushalaniH. Lee Moffitt Cancer Center, Tampa, FL.ORCID 0000-0002-3636-4143
Karl D LewisUniversity of Colorado Cancer Center-Anschutz Medical Campus, Aurora, CO.
Theresa MedinaUniversity of Colorado Cancer Center-Anschutz Medical Campus, Aurora, CO.
Harriet M KlugerYale University School of Medicine, Smilow Cancer Center, New Haven Hospital, New Haven, CT.ORCID 0000-0002-4932-9873
Sajeve S ThomasUniversity of Florida Health Cancer Center at Orlando Health, Orlando, FL.ORCID 0000-0002-0925-3325
Evidio Domingo-MusibayDivision of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN.ORCID 0000-0002-2082-554X
Anna C PavlickLaura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY.
Eric D WhitmanAtlantic Health System Cancer Care, Morristown, NJ.ORCID 0000-0001-7529-067X
Salvador Martin-AlgarraClínica Universidad de Navarra, Pamplona, Spain.
Pippa CorrieCambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital, Cambridge, United Kingdom.ORCID 0000-0003-4875-7021
Brendan D CurtiEarle A. Chiles Research Institute at Robert W. Franz Cancer Center, Providence Cancer Institute, Portland, OR.
Judit OláhUniversity of Szeged-Albert Szent-Györgyi Health Center, Szeged, Hungary.
Jose LutzkyMount Sinai Comprehensive Cancer Center, Miami, FL.ORCID 0000-0002-9503-2130
Jeffrey S WeberLaura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY.ORCID 0000-0002-4962-2957
James M G LarkinRoyal Marsden NHS Foundation Trust, London, United Kingdom.ORCID 0000-0001-5569-9523
Wen ShiIovance Biotherapeutics Inc, San Carlos, CA.ORCID 0000-0002-9206-1411
Toshimi TakamuraIovance Biotherapeutics Inc, San Carlos, CA.
Madan JagasiaIovance Biotherapeutics Inc, San Carlos, CA.ORCID 0000-0001-5757-5604
Harry QinIovance Biotherapeutics Inc, San Carlos, CA.
Xiao WuIovance Biotherapeutics Inc, San Carlos, CA.
Cecile ChartierIovance Biotherapeutics Inc, San Carlos, CA.
Friedrich Graf FinckensteinIovance Biotherapeutics Inc, San Carlos, CA.
Maria FardisIovance Biotherapeutics Inc, San Carlos, CA.
John M KirkwoodHillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, PA.ORCID 0000-0002-3570-4476
Jason A ChesneyJames Graham Brown Cancer Center, University of Louisville, Louisville, KY.
Theravance Biopharma (United States) · USMoffitt Cancer Center · USNYU Langone Health · USUniversity of Colorado Cancer Center · USAngeles Clinic and Research Institute · USAtlantic Health System · USCambridge University Hospitals NHS Foundation Trust · GBClinica Universidad de Navarra · ESOrlando Health · USProvidence Portland Medical Center · USRoyal Marsden NHS Foundation Trust · GBUniversity of Louisville · USUniversity of Minnesota · USUniversity of Szeged · HUUPMC Hillman Cancer Center · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Co-Stimulation to Enhance Adoptive Cell Therapy for Metastatic MelanomaK23CA178083 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI SARNAIK, AMOD · 2013 to 2017
$826k
NCATS NIH HHS UL1 TR001863NCI NIH HHS K23 CA178083
6 · The paper itself

Abstract

purposeEffective treatment options are limited for patients with advanced (metastatic or unresectable) melanoma who progress after immune checkpoint inhibitors and targeted therapies. Adoptive cell therapy using tumor-infiltrating lymphocytes has demonstrated efficacy in advanced melanoma. Lifileucel is an autologous, centrally manufactured tumor-infiltrating lymphocyte product.

methodsWe conducted a phase II open-label, single-arm, multicenter study in patients with advanced melanoma who had been previously treated with checkpoint inhibitor(s) and BRAF ± MEK targeted agents. Lifileucel was produced from harvested tumor specimens in central Good Manufacturing Practice facilities using a streamlined 22-day process. Patients received a nonmyeloablative lymphodepletion regimen, a single infusion of lifileucel, and up to six doses of high-dose interleukin-2. The primary end point was investigator-assessed objective response rate (ORR) per RECIST, version 1.1.

resultsSixty-six patients received a mean of 3.3 prior therapies (anti-programmed death 1 [PD-1] or programmed death ligand 1 [PD-L1]: 100%; anticytotoxic T-lymphocyte-associated protein-4: 80%; BRAF ± MEK inhibitor: 23%). The ORR was 36% (95% CI, 25 to 49), with two complete responses and 22 partial responses. Disease control rate was 80% (95% CI, 69 to 89). Median duration of response was not reached after 18.7-month median study follow-up (range, 0.2-34.1 months). In the primary refractory to anti-PD-1 or PD-L1 therapy subset, the ORR and disease control rate were 41% (95% CI, 26 to 57) and 81% (95% CI, 66 to 91), respectively. Safety profile was consistent with known adverse events associated with nonmyeloablative lymphodepletion and interleukin-2.

conclusionLifileucel demonstrated durable responses and addresses a major unmet need in patients with metastatic melanoma with limited treatment options after approved therapy, including the primary refractory to anti-PD-1 or PD-L1 therapy subset.

Indexed as

AdultAgedFemaleHumansLymphocytes, Tumor-InfiltratingMaleMelanomaMiddle AgedYoung Adult

Identifiers

PMID33979178
PMCPMC8376325
OpenAlexW3162968491

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.