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4. 176 Successful generation of tumor-infiltrating lymphocyte (TIL) product from renal cell carcinoma (RCC) tumors for adoptive cell therapy

Author

Brian Halbert, David Einstein, David McDermott, Emanuelle Andrianopoulos, Mamta Gupta, Virginia Seery, Kenneth Onimus, Courtney Herman, Adrian Wells, Shwetha Lakshmipathi, Arvind Natarajan, Anand Veerapathran, and Rupal Bhatt

Subjects
Pharmacology, Cancer Research, Tumor-infiltrating lymphocytes, business.industry, Immunology, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, Cell therapy, Oncology, Renal cell carcinoma, Product (mathematics), Cancer research, medicine, Molecular Medicine, Immunology and Allergy, business, RC254-282
Abstract

BackgroundPatients with RCC may achieve remission with immune-checkpoint inhibitors (ICI); however, most patients will progress. Adoptive cell therapy with autologous TIL allows for expansion of T-cells from tumor tissue leading to a polyclonal T-cell product with a diverse T-cell receptor repertoire capable of recognizing an array of tumor antigens. TIL therapy with centrally manufactured lifileucel demonstrated a 36% overall response rate in patients with ICI-refractory melanoma.1 We present our preclinical experience of TIL production in RCC.MethodsThis study was approved by the DF/HCC Institutional Review Board. Fresh tumor samples (≥1.5-cm) were harvested from consented patients undergoing resection for RCC. TIL were manufactured using pre-rapid expansion (1/10th scale) and rapid expansion (1/100th scale) protocol for 22 days. Characterization (total viable cells [TVC],% viability, identity, and potency) was performed on the final TIL product. TIL purity, differentiation, memory, activation, and exhaustion status were characterized using multi-color flow cytometry.ResultsBaseline characteristics of 11 recruited patients are shown in table 1. Clear cell was the most common histology (73%). Two patients had previously treated metastatic disease with samples harvested from the lung and adrenal gland; one patient had prior cryoablation with adjacent local recurrence. The remainder were treatment-naïve primary nephrectomy samples. Eight products (73%) showed acceptable TIL product attributes (table 2). Median (range) TVC, viability, and identity (CD45+CD3+%) for the final TIL product were 74×109 (18×109–133×109), 95% (86%–97%), and 98% (94%–99%), respectively. Median (range) percentage of CD4+ cells was 69% (21%–97%) and CD8+ cells was 27% (2%–72%). The non–T-cell population, including B cells, monocytes, and NK cells, was Abstract 176 Table 1Baseline demographics and tumor characteristicsAbstract 176 Table 2Summary of product attributes. 1, No CD3+ subset. 2, Product not available to testConclusionsThese feasibility data suggest that TIL can be successfully expanded ex vivo from RCC samples (including pre-treated and metastatic tumors) and support potential clinical investigation of TIL in patients with RCC.ReferencesSarnaik AA, Hamid O, Khushalani NI, Lewis KD, Medina T, Kluger HM, Thomas SS, Domingo-Musibay E, Pavlick AC, Whitman ED, Martin-Algarra S, Corrie P, Curti BD, Oláh J, Lutzky J, Weber JS, Larkin JMG, Shi W, Takamura T, Jagasia M, Qin H, Wu X, Chartier C, Graf Finckenstein F, Fardis M, Kirkwood JM, Chesney JA. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. J Clin Oncol 2021 May 12:JCO2100612. doi: 10.1200/JCO.21.00612. Epub ahead of print. PMID: 33979178.Ethics ApprovalThis study was approved by the DF/HCC Institutional Review Board protocol # 06-105.

Published
2021
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5. 31st Annual Meeting and Associated Programs of the Society for Immunotherapy of Cancer (SITC 2016): late breaking abstracts

Author

Sonja Althammer, Keith Steele, Marlon Rebelatto, Tze Heng Tan, Tobias Wiestler, Guenter Schmidt, Brandon Higgs, Xia Li, Li Shi, Xiaoping Jin, Joyce Antal, Ashok Gupta, Koustubh Ranade, Gerd Binning, Joaquim Bellmunt, Ronald de Wit, David J. Vaughn, Yves Fradet, Jae Lyun Lee, Lawrence Fong, Nicholas J. Vogelzang, Miguel A. Climent, Daniel P. Petrylak, Toni K. Choueiri, Andrea Necchi, Winald Gerritsen, Howard Gurney, David I. Quinn, Stéphane Culine, Cora N. Sternberg, Yabing Mai, Markus Puhlmann, Rodolfo F. Perini, Dean F. Bajorin, Padmanee Sharma, Margaret K. Callahan, Emiliano Calvo, Joseph W. Kim, Filipo de Braud, Patrick A. Ott, Petri Bono, Rathi N. Pillai, Michael Morse, Dung T. Le, Matthew Taylor, Pavlina Spilliopoulou, Johanna Bendell, Dirk Jaeger, Emily Chan, Scott J. Antonia, Paolo A. Ascierto, Delphine Hennicken, Marina Tschaika, Alex Azrilevich, Jonathan Rosenberg, Ofer Levy, Christopher Chan, Gady Cojocaru, Spencer Liang, Eran Ophir, Sudipto Ganguly, Amir Toporik, Maya Kotturi, Tal Fridman Kfir, Benjamin M. Murter, Kathryn Logronio, Liat Dassa, Ling Leung, Shirley Greenwald, Meir Azulay, Sandeep Kumar, Zoya Alteber, Xiaoyu Pan, Arthur Machlenkin, Yair Benita, Andrew W. Drake, Ayelet Chajut, Ran Salomon, Ilan Vankin, Einav Safyon, John Hunter, Zurit Levine, Mark White, Rom Leidner, Hyunseok Kang, Robert Haddad, Neil H. Segal, Lori J. Wirth, Robert L. Ferris, F. Stephen Hodi, Rachel E. Sanborn, Thomas F. Gajewski, William Sharfman, Dan McDonald, Shivani Srivastava, Xuemin Gu, Penny Phillips, Chaitali Passey, Tanguy Seiwert, Tsadik Habtetsion, Gang Zhou, Donastas Sakellariou-Thompson, Cara Haymaker, Caitlin Creasy, Mark Hurd, Naohiro Uraoka, Jaime Rodriguez Canales, Scott Koptez, Patrick Hwu, Anirban Maitra, Chantale Bernatchez, Scott M. Coyle, Kole T. Roybel, Levi J. Rupp, Stephen P. Santoro, Stephanie Secrest, Michael Spelman, Hanson Ho, Tina Gomes, Tiffany Tse, Chia Yung-Wu, Jack Taunton, Wendell Lim, Peter Emtage, Tarsem Moudgil, Carmen Ballesteros-Merino, Traci Hilton, Christopher Paustian, David Page, Walter Urba, Bernard Fox, Bryan Bell, Ashish Patel, Tove Olafsen, Daulet Satpayev, Michael Torgov, Filippo Marchioni, Jason Romero, Ziyue Karen Jiang, Charles Zamilpa, Jennifer S. Keppler, Alessandro Mascioni, Fang Jia, Chen-Yu Lee, Jean Gudas, Ryan J. Sullivan, Yujin Hoshida, Theodore Logan, Nikhil Khushalani, Anita Giobbie-Hurder, Kim Margolin, Joanna Roder, Rupal Bhatt, Henry Koon, Thomas Olencki, Thomas Hutson, Brendan Curti, Shauna Blackmon, James W. Mier, Igor Puzanov, Heinrich Roder, John Stewart, Asim Amin, Marc S. Ernstoff, Joseph I. Clark, Michael B. Atkins, Howard L. Kaufman, Jeffrey Sosman, Sabina Signoretti, David F. McDermott, Abraham A. Anderson, Mohammed M. Milhem, Robert H. I. Andtbacka, David Minor, Kevin S. Gorski, Daniel M. Baker, Omid Hamid, Emmanuel Akporiaye, Yoshinobu Koguchi, Kim Sutcliffe, Kristie Conder, Thomas Marron, Nina Bhardwaj, Linda Hammerich, Fiby George, Seunghee Kim-Schulze, Tibor Keler, Tom Davis, Elizabeth Crowley, Andres Salazar, Joshua Brody, Arta Monjazeb, Megan E. Daly, Jonathan Riess, Tianhong Li, William J. Murphy, Karen Kelly, Zhiwei Hu, Rulong Shen, Amanda Campbell, Elizabeth McMichael, Lianbo Yu, Bhuvaneswari Ramaswam, Cheryl A. London, Tian Xu, William Carson, Kathleen M. Kokolus, Elizabeth A. Repasky, Todd D. Schell, Joseph D. Drabick, David J. Messenheimer, Shawn Jensen, Mark Rubinstein, Kristina Andrijauskaite, Marzena Swiderska-syn, Kristin Lind, Agnes Choppin, Marina K. Roell, John Wrangle, Peter Rhode, Hing Wong, Shamim Ahmad, Mason Webb, Rasha Abu-Eid, Rajeev Shrimali, Vivek Verma, Atbin Doroodchi, Zuzana Berrong, David Yashar, Raed Samara, Mikayel Mkrtichyan, Samir Khleif, Steven Powell, Mark Gitau, Christopher Sumey, Andrew Terrell, Michele Lohr, Ryan K. Nowak, Steven McGraw, Ash Jensen, Miran Blanchard, Kathryn A. Gold, Ezra E. W. Cohen, Christie Ellison, Lora Black, John Lee, William Chad Spanos, Erik Wennerberg, Emily Schwitzer, Claire Lhuillier, Graeme Koelwyn, Rebecca Hiner, Lee Jones, Sandra Demaria, Vandeveer Amanda, John W. Greiner, Jeffrey Schlom, Michelle Bookstaver, Christopher M. Jewell, Andrew Gunderson, Brian Boulmay, Rui Li, Bradley Spieler, Kyle Happel, Zipei Feng, Christopher Dubay, Brenda Fisher, Sandra Aung, Eileen Mederos, Carlo B. Bifulco, Michael McNamara, Keith Bahjat, William Redmond, Augusto Ochoa, Hong-Ming Hu, Adi Mehta, Fridtjof Lund-Johansen, Frank Bedu-Addo, Greg Conn, Michael King, Panna Dutta, Robert Shepard, Mark Einstein, Sylvia Adams, Ena Wang, Ping Jin, Yelena Novik, Debra Morrison, Ruth Oratz, Franco M. Marincola, David Stroncek, Judith Goldberg, Silvia C. Formenti, Jérôme Galon, Bernhard Mlecnik, Florence Marliot, Fang-Shu Ou, Alessandro Lugli, Inti Zlobec, Tilman T. Rau, Iris D. Nagtegaal, Elisa Vink-Borger, Arndt Hartmann, Carol Geppert, Michael H. Roehrl, Prashant Bavi, Pamela S. Ohashi, Julia Y. Wang, Linh T. Nguyen, SeongJun Han, Heather L. MacGregor, Sara Hafezi-Bakhtiari, Bradley G. Wouters, Yutaka Kawakami, Boryana Papivanova, Mingli Xu, Tomonobu Fujita, Shoichi Hazama, Nobuaki Suzuki, Hiroaki Nagano, Kiyotaka Okuno, Kyogo Itoh, Eva Zavadova, Michal Vocka, Jan Spacek, Lubos Petruzelka, Bohuslav Konopasek, Pavel Dundr, Helena Skalova, Toshihiko Torigoe, Noriyuki Sato, Tomohisa Furuhata, Ichiro Takemasa, Marc Van den Eynde, Anne Jouret-Mourin, Jean-Pascal Machiels, Tessa Fredriksen, Lucie Lafontaine, Bénédicte Buttard, Sarah Church, Pauline Maby, Helen Angell, Mihaela Angelova, Angela Vasaturo, Gabriela Bindea, Anne Berger, Christine Lagorce, Prabhu S. Patel, Hemangini H. Vora, Birva Shah, Jayendrakumar B. Patel, Kruti N. Rajvik, Shashank J. Pandya, Shilin N. Shukla, Yili Wang, Guanjun Zhang, Giuseppe V. Masucci, Emilia K. Andersson, Fabio Grizzi, Luigi Laghi, Gerardo Botti, Fabiana Tatangelo, Paolo Delrio, Gennaro Cilberto, Franco Marincola, Daniel J. Sargent, Bernard A. Fox, Alain Algazi, Katy Tsai, Michael Rosenblum, Prachi Nandoskar, Amy Li, John Nonomura, Kathryn Takamura, Mary Dwyer, Erica Browning, Reneta Talia, Chris Twitty, Sharron Gargosky, Jean Campbell, Mai Le, Robert H. Pierce, Adil Daud, Robyn Gartrell, Douglas Marks, Edward Stack, Yan Lu, Daisuke Izaki, Kristen Beck, Dan Tong Jia, Paul Armenta, Ashley White-Stern, Yichun Fu, Zoe Blake, Bret Taback, Basil Horst, Yvonne M. Saenger, Steven Leonardo, Keith Gorden, Ross B. Fulton, Kathryn Fraser, Takashi O. Kangas, Richard Walsh, Kathleen Ertelt, Jeremy Graff, Mark Uhlik, Jennifer S. Sims, Liang Lei, Takashi Tsujiuchi, Jeffrey N. Bruce, Peter Canoll, Anthony W Tolcher, Evan W Alley, Gurunadh Chichili, Jan E Canoll, Paul Moore, Ezio Bonvini, Syd Johnson, Sadhna Shankar, James Vasselli, Jon Wigginton, and John Powderly

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Durvalumab, medicine.medical_treatment, Immunology, Improved survival, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Immunology and Allergy, Pharmacology, business.industry, Cancer, Immunotherapy, medicine.disease, 3. Good health, 030104 developmental biology, 030220 oncology & carcinogenesis, Molecular Medicine, Non small cell, business
Abstract

O1 Combinatorial CD8+ and PD-L1+ cell densities correlate with response and improved survival in non-small cell lung cancer (NSCLC) patients treated with durvalumab #### Sonja Althammer1, Keith Steele2, Marlon Rebelatto2, Tze Heng Tan1, Tobias Wiestler1, Guenter Schmidt1, Brandon Higgs2, Xia

Published
2016
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