Publication and Scientific Presentations

2018

Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients following progression on checkpoint inhibitors PDF Poster | SITC Annual Meeting,  November 9-11, 2018 | Washington, DC, USA

Amod Sarnaik¹, Sajeve Samuel Thomas², Diwakar Davar³, John M. Kirkwood³, Harriet Kluger⁴, Jose Lutzky⁵, Melissa Wilson⁶, Anna C. Pavlick⁷, Brendan Curti⁸, Eric Whitman⁹, Karl Lewis¹⁰, Giao Phan¹¹, Omid Hamid¹², Evidio Domingo-Musibay¹³, Marc Ernstoff¹⁴, Hendrik-Tobias Arkenau¹⁵, Judit Olah¹⁶, Pippa Corrie¹⁷, Stéphane Dalle¹⁸, Salvador Algarra¹⁹, Gregory Daniels²⁰, Lavakumar Karyampudi²¹, Toshimi Takamura²¹, Debora Barton²¹, Sam Suzuki²¹, Nancy L. Samberg²¹, Maria Fardis²¹, Jason Chesney²²

 ¹Moffitt Cancer Center, Tampa, FL, USA; ²Univ. of Florida Health Cancer Center, Orlando, FL, USA; ³Univ. of Pittsburgh-Hillman Cancer Center, Pittsburgh, PA, USA ⁴Yale Cancer Center, New Haven, CT, USA; ⁵Mount Sinai Comprehensive Cancer Center, Miami Beach, FL, USA; ⁶Thomas Jefferson Kimmel Cancer Center, Philadelphia, PA, USA; ⁷NYU Perlmutter Cancer Center-Langone, New York, NY, USA; ⁸Earle A. Chiles Research Institute-Providence Cancer Center, Portland, OR, USA; ⁹Atlantic Health System Cancer Care, Morristown, NJ, USA; ¹⁰Univ. of Colorado Health Cancer Care-Anschutz Medical Campus; Aurora, CO, USA; ¹¹Virginia Commonwealth University-School of Medicine, Richmond, VA, USA; ¹² The Angeles Clinic, Los Angeles, CA, USA; ¹³Univ. of Minnesota Health-Masonic Cancer Center, Minneapolis, MN, USA ¹⁴ Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA; ¹⁵Sarah Cannon Research Institute, London, UK ¹⁶Szegedi Tudomanyegyetem Szent-Györgyi Albert Klinikai Központ, Csongrad, HU; ¹⁷Addenbrooke’s Hospital, Cambridge, UK; ¹⁸Centre Hospitalier Lyon Sud, Rhone-Alpes, FR; ¹⁹Clínica Universidad de Navarra, Pamplona, Navarra, ES; ²⁰University of California San Diego-Moores Cancer Center, San Diego, CA, USA; ²¹Iovance Biotherapeutics, San Carlos, CA, USA; ²²James Graham Brown Cancer Center

PD1-positive tumor-infiltrating lymphocytes (TIL) for the next generation of adoptive T cell therapy PDF Poster | SITC Annual Meeting,  November 9-11, 2018 | Washington, DC, USA

Michelle R. Simpson-Abelson, Kenneth D’Arigo, Angel Cedano-Hilton, Ian Frank, Viktoria Gontcharova, Krit Ritthipichai, and Cécile Chartier

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
PDF Poster | ASCO ANNUAL MEETING, JUNE 1-5, 2018 | CHICAGO, IL, USA
Abstract TPS9595 and poster number 422a – poster presented Monday, June 4^th
Amod Sarnaik¹, Brendan Curti², Diwakar Davar³, John M. Kirkwood³, Omid Hamid⁴, Jose Lutzky⁵, Melissa Wilson⁶, Harriet Kluger⁷, Eric Whitman⁸ , Giao Phan⁹, Sajeve Samuel Thomas¹⁰,Karl Lewis¹¹, Hendrik-Tobias Arkenau¹², Bente Larsen¹³, Igor Gorbatchevsky¹³, Corina Andresen¹³,  Sam Suzuki¹³, Nancy Samberg¹³, Maria Fardis¹³, Jason Chesney^{14 1}Moffitt Cancer Center, Tampa, FL; ²Earle A. Chiles Research Institute, Providence Cancer Center, Portland, OR; ³University of Pittsburgh Medical Center – Hillman Cancer Center, Pittsburgh, PA; ⁴The Angeles Clinic and Research Institute, Los Angeles, CA; ⁵Mount Sinai Comprehensive Cancer Center, Miami Beach, FL; ⁶New York University – Perlmutter Cancer Center – Langone Medical Center, New York, NY; ⁷Yale Cancer Center, New Haven, CT; ⁸ Atlantic Health System Cancer Care, Morristown, NJ; ⁹Virginia Commonwealth University, Richmond, VA; ¹⁰University of Florida Health Cancer Center, Orlando, FL; ¹¹University of Colorado Cancer Center, Denver CO; ¹²Sarah Cannon Research Institute London UK; ¹³Iovance Biotherapeutics, San Carlos, CA; ¹⁴James Graham Brown Cancer Center, Louisville, KY

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) for the Treatment of Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
PDF Poster | ASCO ANNUAL MEETING, JUNE 1-5, 2018 | CHICAGO, IL, USA
Abstract TPS6096 and poster number 81a – poster presented Saturday, June 2^nd 
Rom Leidner¹, Ammar Sukari², Christine Chung³, James Ohr⁴, Missak Haigentz⁵, Ezra E. W. Cohen⁶, Robert J. Brown⁷, Igor Gorbatchevsky⁷, Sam Suzuki⁷, Maria Fardis⁷, Robert L. Ferris^{4 1}Earle A. Chiles Research Institute – Providence Cancer Center, Portland, OR;  ²Barbara Ann Karmanos Cancer Institute, Detroit, MI;  ³Moffitt Cancer Center, Tampa, FL;  ⁴University of Pittsburgh Medical Center, Pittsburgh, PA; ⁵Morristown Medical Center/Atlantic Health System, Morristown, NJ; ⁶University of California, San Diego, CA; ⁷Iovance Biotherapeutics, San Carlos, CA

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma 
PDF Poster | ASCO ANNUAL MEETING, JUNE 1-5, 2018 | CHICAGO, IL, USA
Abstract TPS5604 and poster number 329a – poster presented on Monday, June 4^th
Amir Jazaeri¹, Robert Edwards², Robert Wenham³, Koji Matsuo⁴, Gini F. Fleming⁵, David M. O’Malley⁶, Brian Slomovitz⁷, Bradley Monk⁸, Robert J. Brown⁹, Igor Gorbatchevsky⁹, Sam Suzuki⁹, Maria Fardis⁹, Emese Zsiros^{10  1}MD Anderson Cancer Center, Houston, TX; ²University of Pittsburgh Medical Center – Hillman Cancer Center, Pittsburgh, PA; ³Moffitt Cancer Center, Tampa, FL; ⁴Norris Cancer Center, University of Southern California, Los Angeles, CA; ⁵University of Chicago, Chicago, IL; ⁶The James Cancer Center, Ohio State University, Columbus, OH; ⁷Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL; ⁸Arizona Oncology, University of Arizona College of Medicine, and Phoenix Creighton University School of medicine at St. Joseph’s Hospital, Phoenix, AZ;  ⁹Iovance Biotherapeutics, San Carlos, CA; ¹⁰Roswell Park Cancer Institute, Pittsburgh, PA

Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination with Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
PDF Poster | ASCO ANNUAL MEETING, JUNE 1-5, 2018 | CHICAGO, IL, USA
Abstract TPS3107 and poster number 318a – poster presented on Monday, June 4^th
Sylvia Lee¹, Liza Villaruz², Susie Tanamly³, Igor Gorbatchevsky³, Corina Andresen³,  Sam Suzuki³, Maria Fardis³, Missak Haigentz^{4   1}University of Washington, Seattle, WA; ²University of Pittsburgh Medical Center – Hillman Cancer Center, Pittsburgh, PA; ³Iovance Biotherapeutics, San Carlos, CA; ⁴Atlantic Health System/Morristown Medical Center, Morristown, NJ

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
PDF Poster | AACR ANNUAL MEETING, APRIL 14-18, 2018 | CHICAGO, IL, USA
Amod Sarnaik¹, Brendan Curti², Diwakar Davar³, Omid Hamid⁴, Jose Lutzky⁵, Melissa Wilson⁶, Harriet Kluger⁷, Jason Chesney⁸, Kevin Kim⁹, Giao Phan¹⁰, Sajeve Thomas¹¹, Igor Gorbatchevsky¹², Bente Larsen¹², Sam Suzuki¹², Nancy Samberg¹², Maria Fardis¹², John M. Kirkwood³

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) for the Treatment of Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
PDF Poster | AACR ANNUAL MEETING, APRIL 14-18, 2018 | CHICAGO, IL, USA
Rom Leidner¹, Ammar Sukari², Christine Chung³, James Ohr⁴, Missak Haigentz⁵, Ezra E. W. Cohen⁶, Robert J. Brown⁷, Igor Gorbatchevsky⁷, Sam Suzuki⁷, Maria Fardis⁷, Robert L. Ferris⁴

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma
PDF Poster | AACR ANNUAL MEETING, APRIL 14-18, 2018 | CHICAGO, IL, USA
Amir Jazaeri¹, Robert Edwards², Robert Wenham³, Koji Matsuo⁴, Gini F. Fleming⁵, David M. O’Malley⁶, Brian Slomovitz⁷, Bradley Monk⁸, Robert J. Brown⁹, Igor Gorbatchevsky⁹, Sam Suzuki⁹, Maria Fardis⁹, Emese Zsiros¹⁰

Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination with Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
PDF Poster | AACR ANNUAL MEETING, APRIL 14-18, 2018 | CHICAGO, IL, USA
Sylvia Lee¹, Liza Villaruz², Susie Tanamly³, Igor Gorbatchevsky³, Sam Suzuki³, Maria Fardis³, Missak Haigentz⁴

Anti-OX40 Agonistic Antibody Enhances ex vivo CD8+ TIL Expansion with Increased T-cell Effector Function
PDF Poster | AACR ANNUAL MEETING, APRIL 14-18, 2018 | CHICAGO, IL, USA
Krit Ritthipichai, Marcus Machin, Maria Fardis, and Cecile Chartier

2017

Novel Cryopreserved Tumor Infiltrating Lymphocytes (LN-144) Administered to Patients with Metastatic Melanoma Demonstrates Efficacy and Tolerability in a Multicenter Phase 2 Clinical Trial
PDF Poster | SITC ANNUAL MEETING, NOVEMBER 8 2017 | NATIONAL HARBOR, MD, USA
Amod Sarnaik¹, Jason Chesney², Harriet Kluger³, Brendan Curti⁴, Omid Hamid⁵, Jose Lutzky⁶, Maria Fardis⁷, Igor Gorbatchevsky⁷, Sam Suzuki⁷, Bente Larsen⁷, Nancy L. Samberg⁷, John Kirkwood⁸

A Cryopreserved Tumor Infiltrating Lymphocyte (TIL) Product for LN-144, Generated with an Abbreviated Method Suitable for High Throughput Commercial Manufacturing Exhibits Favorable Quality Attributes For Adoptive Cell Transfer
PDF Poster | SITC ANNUAL MEETING, NOVEMBER 8 2017 | NATIONAL HARBOR, MD, USA
Seth Wardell, Ian Frank, Lavakumar Karyampudi, Anand Veerapathran, Michelle Simpson-Abelson, Maritza Lienlaf Moreno, Michelle Blaskovich, Joseph Wypych, and Maria Fardis

Studies of Key Quality Attributes for TIL Product, LN-144
PDF Poster | SITC ANNUAL MEETING, NOVEMBER 8 2017 | NATIONAL HARBOR, MD, USA
Krit Ritthipichai, Ian Frank, Marcus Machin, Michelle Blaskovich, Amanda Stramer, Michelle Simpson-Abelson, Maria Fardis, Cecile Chartier

A phase 2 study to evaluate the safety and efficacy of using of using autologous tumor infiltrating lymphocytes (LN -145) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck
PDF Poster | SITC ANNUAL MEETING, NOVEMBER 8 2017 | NATIONAL HARBOR, MD, USA
Leidner R¹, Ohr J², Chung C³, Brown RJ⁴, Suzuki S⁴, Gorbatchevsky I⁴, Fardis M⁴, and Ferris RL²

A phase 2, multicenter study to evaluate the efficacy and safety of using autologous tumor infiltrating lymphocytes (LN-145) in patients with recurrent, metastatic, or persistent cervical carcinoma
PDF Poster | SITC ANNUAL MEETING, NOVEMBER 8 2017 | NATIONAL HARBOR, MD, USA
Amir Jazaeri¹, Robert Edwards², Emese Zsiros³, Robert Brown⁴, Igor Gorbatchevsky⁴, Sam Suzuki⁴, Maria Fardis⁴, Robert Wenham⁵

The T-cell Growth Factor Cocktail IL-2/IL-15/IL-21 Enhances Expansion and Effector Function of Tumor-Infiltrating T cells in a Novel Process Developed by Iovance
PDF Poster | SITC ANNUAL MEETING, NOVEMBER 8 2017 | NATIONAL HARBOR, MD, USA
Michelle R. Simpson-Abelson, Christopher Mosychuk, Ian Frank, Krit Ritthipichai, and Cecile Chartier

Phenotypic and Functional Characterization of Tumor Infiltrating Lymphocytes (TIL) Grown from Non-Hodgkin Lymphoma Tumors – Implications for the Development of Novel Therapies for Lymphoma
PDF Poster | ESMO Annual Meeting, September 7-12, 2017 | Madrid, Spain
Lavakumar Karyampudi, Aishwarya Gokuladass, Michelle Blaskovich, Maria Fardis, Michael T Lotze

TIL Candidate Shows Potential in Metastatic Melanoma Based on Interim Data
News Feature | Drug Discovery & Development, 06/23/2017

Efficacy of Single Administration of Tumor Infiltrating Lymphocytes (TIL) in Heavily Pre-Treated Metastatic Melanoma Patients Following Checkpoint Therapy
PDF Poster | ASCO Annual Meeting 2017
Amod Sarnaik, Harriet Kluger, Jason Chesney, Jyothi Sethuraman, Michael T. Lotze, Bente Larsen, Igor Gorbatchevsky, Nancy L. Samberg, Sam Suzuki, Lei Wang, Mariam Mirgoli, Maria Fardis, Brendan Curti

K+ Channel Activation Promotes Tumor Infiltrating Lymphocyte (TIL) Expansion and Enhances Expression of CCR7
PDF Poster | AAI Annual Meeting 2017
Krit Ritthipichai, Marcus Machin, Michelle Simpson-Abelson, Christopher Mosychuk, Anand Veerapathran, and Michael T. Lotze

Emigrant Tumor Infiltrating Lymphocytes Profoundly Differ from Remnant T cells
PDF Poster | AACR Annual Meeting 2017
Michelle R. Simpson-Abelson, Christopher Mosychuk, Maria Fardis, and Michael T. Lotze

2016

P14 Bioluminescent redirected lysis assay (BRLA) as an efficient potency assay to assess tumor-infiltrating lymphocytes (TILs) for immunotherapy
PDF Poster | Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1):82, DOI 10.1186/s40425-016-0172-7
Aishwarya Gokuldass, Michelle A Blaskovich, Charlene Kopits, Brian Rabinovich, Michael T. Lotze

P11 Stable tumor-infiltrating lymphocytes (TIL) phenotype following cryopreservation
PDF Poster | Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1):82, DOI 10.1186/s40425-016-0172-7
Ian Frank, Amanda Stramer, Michelle A Blaskovich, Seth Wardell, Maria Fardis, James Bender, Michael T Lotze

P41 Successful expansion and characterization of tumor infiltrating lymphocytes (TILs) from non-melanoma tumors
PDF Poster | Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1):82, DOI 10.1186/s40425-016-0172-7
Jyothi Sethuraman, Laurelis Santiago, Jie Qing Chen, Zhimin Dai, Seth Wardell, James Bender, Michael T Lotze

P46 Artificial antigen presenting cells promote expansion of tumor infiltrating lymphocytes (TILs)
PDF Poster | Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1):82, DOI 10.1186/s40425-016-0172-7
Anandaraman Veerapathran, Aishwarya Gokuldass, Amanda Stramer, Jyothi Sethuraman, Michelle A Blaskovich, Doris Wiener, Ian Frank, Laurelis Santiago, Brian Rabinovich, Maria Fardis, James Bender, Michael T Lotze

Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor-Infiltrating Lymphocytes for Patients With Metastatic Melanoma
PubMed | Journal of Clinical Oncology 2016 34:20, 2389-2397, doi: 10.1200/JCO.2016.66.7220
Goff SL, Dudley ME, Citrin DE, Somerville RP, Wunderlich JR, Danforth DN, Zlott DA, Yang JC, Sherry RM, Kammula US, Klebanoff CA, Hughes MS, Restifo NP, Langhan MM, Shelton TE, Lu L, Kwong MLM, Ilyas S, Klemen ND, Payabyab EC, Morton KE, Toomey MA, Steinberg SM, White DE, and Rosenberg SA

2015

Adoptive cell transfer as personalized immunotherapy for human cancer
Science | Science 03 Apr 2015, Vol. 348, Issue 6230, pp. 62-68, DOI 10.1126/science.aaa4967
Rosenberg SA, and Restifo NP

Manipulating the tumor microenvironment ex vivo for enhanced expansion of tumor-infiltrating lymphocytes for adoptive cell therapy.
PubMed | Clin Cancer Res. 2015;21(3):611-21
Chacon JA, Sarnaik AA, Chen JQ, et al.

2014

Finding suitable targets is the major obstacle to cancer gene therapy
Nature | Cancer Gene Ther. 2014;21(2):45-7
Rosenberg SA

Exploiting the curative potential of adoptive T-cell therapy for cancer
PubMed | Immunol Rev. 2014;257(1):56-71
Hinrichs CS, Rosenberg SA