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
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.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (45)
Theresa Medina
From the Sandra and Edward Meyer Cancer Center (J.D.W.) and the Department of Medicine (J.D.W., M.A.P.), Weill Cornell Medicine, and Memorial Sloan Kettering Cancer Center (M.A.P.) — both in New York; Istituto Oncologico Veneto, IRCCS, Padua (V.C.-S.), European Institute of Oncology, IRCCS, Milan (P.Q.), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola (M.G.), University of Siena and the Center for Immuno-Oncology, University Hospital of Siena, Siena (M.M.), and Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.) — all in Italy; Maria Sklodowska-Curie National Institute of Oncology, Warsaw, Poland (P.R.); Texas Oncology–Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); University Hospital Essen, the German Cancer Consortium, the National Center for Tumor Diseases–West, the Research Alliance Ruhr, Research Center One Health, and University Duisburg-Essen — all in Essen, Germany (D.S.); the College of Medicine, Swansea University, Swansea (J.W.), Brist...
Jason A. Chesney
James Graham Brown Cancer Center, University of Louisville, Louisville, KY
Harriet M. Kluger
Omid Hamid
5The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate, Translational Research & ImmunoOncolgy, Los Angeles, United States
Eric D. Whitman
Atlantic Health System, Morristown, NJ
Mike Cusnir
1Mount Sinai Medical Center, Hematology Oncology, Miami Beach, United States
Sajeve S. Thomas
AdventHealth Orlando, Orlando, FL
Martin Wermke
National Center for Tumor Diseases–University Cancer Center Early Clinical Trial Unit, Technische Universität Dresden, Dresden, Germany
Evidio Domingo-Musibay
Allina Health Cancer Institute, Minneapolis, MN
Giao Q. Phan
UConn Health/Neag Cancer Center, Farmington, CT
John M. Kirkwood
James Larkin
Jeffrey Weber
Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY
Friedrich Graf Finckenstein
Iovance Biotherapeutics, Inc, San Carlos, CA
Jeffrey Chou
Iovance Biotherapeutics, Inc, San Carlos, CA
Brian Gastman
The Cleveland Clinic Foundation, Cleveland, OH
Xiao Wu
Rana Fiaz
Iovance Biotherapeutics, Inc, San Carlos, CA
Amod A. Sarnaik
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Brendan Curti
Kevin Kim
Occidental College
Gregory Daniels
Melissa Wilson
Sylvia Lee
Colorado State University, Fort Collins, Colorado, United States
Igor Puzanov
Amy Harker-Murray
Theodore Logan
Jan Christoph Simon
Ioannis Thomas
Beatrice Schuler-Thurner
Rose Moritz
Jessica Hassel
Gotz Ulrich Grigoliet
Ana Arance
Hospital Clinic Barcelona and IDIBAPS, Barcelona, Spain
Belen Rubio
Juan Rodriguez
Alfonso Berrocal
Miguel de Sanmamed
Hendrik-Tobias Arkenau
Ellipses Pharma, London, United Kingdom
Thomas Evans
Pippa Corrie
Stéphane Dalle
Christoph Bedane
Judit Oláh
Angela Orcurto