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Cancer Therapy: Clinical

Long-Lasting Complete Responses in Patients with Metastatic Melanoma after Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes and an Attenuated IL2 Regimen

Rikke Andersen, Marco Donia, Eva Ellebaek, Troels Holz Borch, Per Kongsted, Trine Zeeberg Iversen, Lisbet Rosenkrantz Hölmich, Helle Westergren Hendel, Özcan Met, Mads Hald Andersen, Per thor Straten and Inge Marie Svane
Rikke Andersen
1Center for Cancer Immune Therapy, Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
2Department of Oncology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Marco Donia
1Center for Cancer Immune Therapy, Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
2Department of Oncology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Eva Ellebaek
1Center for Cancer Immune Therapy, Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
2Department of Oncology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Troels Holz Borch
1Center for Cancer Immune Therapy, Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
2Department of Oncology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Per Kongsted
1Center for Cancer Immune Therapy, Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
2Department of Oncology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Trine Zeeberg Iversen
1Center for Cancer Immune Therapy, Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
2Department of Oncology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Lisbet Rosenkrantz Hölmich
3Department of Plastic Surgery, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Helle Westergren Hendel
4Department of Clinical Physiology and Nuclear Medicine, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Özcan Met
1Center for Cancer Immune Therapy, Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
2Department of Oncology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Mads Hald Andersen
1Center for Cancer Immune Therapy, Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Per thor Straten
1Center for Cancer Immune Therapy, Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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Inge Marie Svane
1Center for Cancer Immune Therapy, Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
2Department of Oncology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
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  • For correspondence: inge.marie.svane@regionh.dk
DOI: 10.1158/1078-0432.CCR-15-1879 Published August 2016
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Abstract

Purpose: Adoptive cell transfer therapy (ACT) based on autologous tumor-infiltrating lymphocytes (TIL) has achieved impressive clinical results in several phase I and II trials performed outside of Europe. Although transient, the toxicities associated with high-dose (HD) bolus IL2 classically administered together with TILs are severe. To further scrutinize whether similar results can be achieved with lower doses of IL2, we have carried out a phase I/II trial of TIL transfer after classical lymphodepleting chemotherapy followed by an attenuated IL2 regimen.

Experimental Design: Twenty-five patients with progressive treatment-refractory metastatic melanoma, good clinical performance, age < 70 years, and at least one resectable metastasis were eligible. TIL infusion was preceded by standard lymphodepleting chemotherapy and followed by attenuated doses of IL2 administered in an intravenous, continuous decrescendo regimen (ClinicalTrials.gov Identifier: NCT00937625).

Results: Classical IL2-related toxicities were observed but patients were manageable in a general oncology ward without the need for intervention from the intensive care unit. RECIST 1.0 evaluation displayed three complete responses and seven partial responses (ORR 42%). Median overall survival was 21.8 months. Tumor regression was associated with a higher absolute number of infused tumor-reactive T cells. Moreover, induction and persistence of antimelanoma T-cell responses in the peripheral blood was strongly correlated to clinical response to treatment.

Conclusions: TIL-ACT with a reduced IL2 decrescendo regimen results in long-lasting complete responses in patients with treatment-refractory melanoma. Larger randomized trials are needed to elucidate whether clinical efficacy is comparable with TIL-ACT followed by HD bolus IL2. Clin Cancer Res; 22(15); 3734–45. ©2016 AACR.

This article is featured in Highlights of This Issue, p. 3705

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Received August 25, 2015.
  • Revision received January 15, 2016.
  • Accepted February 20, 2016.
  • ©2016 American Association for Cancer Research.
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Clinical Cancer Research: 22 (15)
August 2016
Volume 22, Issue 15
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Long-Lasting Complete Responses in Patients with Metastatic Melanoma after Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes and an Attenuated IL2 Regimen
Rikke Andersen, Marco Donia, Eva Ellebaek, Troels Holz Borch, Per Kongsted, Trine Zeeberg Iversen, Lisbet Rosenkrantz Hölmich, Helle Westergren Hendel, Özcan Met, Mads Hald Andersen, Per thor Straten and Inge Marie Svane
Clin Cancer Res August 1 2016 (22) (15) 3734-3745; DOI: 10.1158/1078-0432.CCR-15-1879

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Long-Lasting Complete Responses in Patients with Metastatic Melanoma after Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes and an Attenuated IL2 Regimen
Rikke Andersen, Marco Donia, Eva Ellebaek, Troels Holz Borch, Per Kongsted, Trine Zeeberg Iversen, Lisbet Rosenkrantz Hölmich, Helle Westergren Hendel, Özcan Met, Mads Hald Andersen, Per thor Straten and Inge Marie Svane
Clin Cancer Res August 1 2016 (22) (15) 3734-3745; DOI: 10.1158/1078-0432.CCR-15-1879
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