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      Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies.

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          Abstract

          10006

          Background: Treatment options are limited for patients with advanced melanoma who have progressed on checkpoint inhibitors and targeted therapies. Adoptive cell therapy using tumor-infiltrating lymphocytes (TIL) leverages and enhances the body’s natural defense against cancer and has shown durable responses in heavily pretreated melanoma patients. Methods: C-144-01 is a global Phase 2 open-label, multicenter study of efficacy & safety of lifileucel in patients with unresectable metastatic melanoma who have progressed on checkpoint inhibitors and BRAF/MEK inhibitors, if BRAF v600 mutant. We report on Cohort 2 (N = 66) patients who have received TIL. Tumors were resected at local institutions, processed in central GMP facilities for TIL production, manufactured, cryopreserved & shipped back to sites in a 22-day process. Therapy consisted of one week of lymphodepletion, a single lifileucel infusion, and up to 6 IL-2 doses. ORR was based on RECIST v1.1 by investigator assessment. Data cutoff was Feb 2, 2020. Results: Baseline characteristics: 3.3 mean prior therapies (anti-PD1 100%; anti-CTLA-4 80%; BRAF/MEK inhibitor 23%), high baseline tumor burden (106 mm mean target lesion sum of diameters), 44% liver/brain lesions, 40.9% LDH > ULN. ORR by investigator was 36.4% (2 CR, 22 PR) and DCR was 80.3%. Mean time to response was 1.9 months (range: 1.3-5.6). After a median study follow-up of 17.0 months, median DOR (mDOR) was still not reached. Six responders have progressed, 2 have died and 2 started other anti-cancer therapy without progression. The adverse event profile was consistent with the underlying advanced disease and the lymphodepletion and IL-2 regimens. Additional follow-up data will be available for presentation. Conclusions: Lifileucel treatment results in a 36.4% ORR and mDOR was not reached at 17.0 months of median study follow up in a heavily pretreated metastatic melanoma patients with high baseline disease burden who progressed on multiple prior therapies, including anti-PD1 and BRAF/MEK inhibitors, if BRAF v600 mutant. Clinical trial information: NCT02360579.

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          Author and article information

          Journal
          Journal of Clinical Oncology
          JCO
          American Society of Clinical Oncology (ASCO)
          0732-183X
          1527-7755
          May 20 2020
          May 20 2020
          : 38
          : 15_suppl
          : 10006
          Affiliations
          [1 ]Moffitt Cancer Center, Tampa, FL;
          [2 ]James Graham Brown Cancer Center, University of Louisville, Louisville, KY;
          [3 ]University of Colorado Denver, School of Medicine, Aurora, CO;
          [4 ]University of Colorado, Castle Rock, CO;
          [5 ]Yale School of Medicine and Smilow Cancer Center, Yale New Haven Hospital, New Haven, CT;
          [6 ]University of Florida Health Cancer Center, Windermere, FL;
          [7 ]Mayo Clinic, Rochester, MN;
          [8 ]Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY;
          [9 ]Atlantic Health System Cancer Care, Morristown, NJ;
          [10 ]Clinica Universidad de Navarra, Pamplona, Spain;
          [11 ]Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom;
          [12 ]Mount Sinai Medical Center, Miami Beach, FL;
          [13 ]The Angeles Clinic and Research Institute, Los Angeles, CA;
          [14 ]Iovance Biotherapeutics, Inc., San Carlos, CA;
          [15 ]FibroGen, Inc., San Francisco, CA;
          [16 ]The Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom;
          [17 ]Melanoma Program, UPMC Hillman Cancer Center, Pittsburgh, PA;
          Article
          10.1200/JCO.2020.38.15_suppl.10006
          51326711-31ce-40f5-947e-ca76e9baa2ad
          © 2020
          History

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