Toni K. Choueiri MD¹, Thomas Powles², Camillo Porta³, Masatoshi Eto⁴, Viktor Grünwald⁵, Thomas E. Hutson⁶, Boris Alekseev⁷, Sun Young Rha⁸, Evgeny Kopyltsov⁹, Maria José Méndez-Vidal¹⁰, Anil Kapoor¹¹, Teresa Alonso Gordoa¹², Jeffrey C. Goh¹³, Jaime R. Merchan¹⁴, Se Hoon Park¹⁵, Michael Staehler¹⁶, Alan D. Smith¹⁷, Jodi McKenzie¹⁸, Rodolfo F. Perini¹⁹, Cixin He¹⁸, Robert Motzer²⁰

¹Dana-Farber Cancer Institute, Boston, MA, USA. ²The Royal Free NHS Trust, London, England, UK. ³San Matteo University Hospital Foundation, Pavia, Italy. ⁴Kyushu University, Fukuoka, Japan. ⁵University Hospital Essen, Essen, Germany. ⁶Texas Oncology, Dallas, TX, USA. ⁷P.A. Hertsen Moscow Cancer Research Institute, Moscow, Russia. ⁸Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea. ⁹State Institution of Healthcare “Regional Clinical Oncology Dispensary”, Omsk, Russia. ¹⁰Maimonides Institute for Biomedical research of Cordoba (IMIBIC) Hospital Universitario Reina Sofía, Medical Oncology Department, Córdoba, Spain. ¹¹McMaster University Hamilton, Ontario, Canada. ¹²Hospital Universitario Ramón y Cajal, Madrid, Spain. ¹³ICON Research, South Brisbane & University of Queensland, St Lucia, Queensland, Australia. ¹⁴University of Miami Sylvester Comprehensive Cancer Center, Miami, FL, USA. ¹⁵Sungkyunkwan University Samsung Medical Center, Seoul, Korea. ¹⁶University Hospital, Ludwig Maximilian University of Munich, Munich, Germany. ¹⁷Eisai Ltd., Hatfield, UK. ¹⁸Eisai Inc., Woodcliff Lake, NJ, USA. ¹⁹Merck & Co., Inc., Kenilworth, NJ, USA. ²⁰Memorial Sloan Kettering Cancer Center; New York, NY, USA

Characterization of responders in the phase 3 CheckMate 9ER trial: nivolumab plus cabozantinib versus sunitinib in patients with previously untreated advanced renal cell carcinoma

Amishi Y. Shah¹, Thomas Powles², Maria T. Bourlon³, Cristina Suarez⁴, Toni K. Choueiri⁵, Robert J. Motzer⁶, Saby George⁷, Elizabeth R. Kessler⁸, Jens Bedke⁹, Bernard Escudier¹⁰, Joshua Zhang¹¹, Burcin Simsek¹², Christian Scheffold¹³, Andrea B. Apolo¹⁴, Mauricio Burotto¹⁵

¹Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA. ²Department of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, UK. ³Department of Hemato-Oncology, Urologic Oncology Clinic, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. ⁴Department of Medical Oncology, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain. ⁵Department of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Harvard Medical School, Boston, MA, USA. ⁶Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. ⁷Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. ⁸Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA. ⁹Department of Urology, Eberhard Karls University Tübingen, Tübingen, Germany. ¹⁰Department of Medical Oncology, Gustave Roussy, Villejuif, France. ¹¹Department of Clinical Research, Bristol Myers Squibb, Princeton, NJ, USA. ¹²Department of Biostatistics, Bristol Myers Squibb, Princeton, NJ, USA. ¹³Product Development, Exelixis, Inc., Alameda, CA, USA. ¹⁴Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA. ¹⁵Bradford Hill Clinical Research Center, Santiago, Chile

Pembrolizumab (pembro) vs placebo as post nephrectomy adjuvant therapy for patients with renal cell carcinoma (RCC): randomized, double-blind, phase 3 KEYNOTE-564 study

Dr. Toni K. Choueiri¹, Piotr Tomczak², Se Hoon Park³, Balaji Venugopal⁴, Thomas Ferguson⁵, Yen-Hwa Chang⁶, Jaroslav Hajek⁷, Stefan N. Symeonides⁸, Jae Lyun Lee⁹, Naveed Sarwar¹⁰, Antoine Thiery-Vuillemin¹¹, Marine Gross-Goupil¹², Mauricio Mahave¹³, Naomi Haas¹⁴, Piotr Sawrycki¹⁵, Todd L. Saretsky¹⁶, Rodolfo F. Perini¹⁶, Pingye Zhang¹⁶, Kentaro Imai¹⁶, Jaqueline Willemann-Rogerio¹⁶, David Quinn¹⁷, Thomas Powles¹⁸

¹Dana-Farber Cancer Institute, Boston, MA, USA. ²Poznań University of Medical Sciences, Poznań, Poland. ³Sungkyunkwan University, Samsung Medical Center, Seoul, South Korea. ⁴Beatson West of Scotland Cancer Centre, Glasgow, U.K, and University of Glasgow, Glasgow, UK. ⁵Fiona Stanley Hospital, Perth, Australia. ⁶Taipei Veterans General Hospital, Taipei, Taiwan. ⁷Fakultni Nemocnice Ostrava, Ostrava, Czech Republic. ⁸Edinburgh Cancer Centre and University of Edinburgh, UK. ⁹Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. ¹⁰Imperial College Healthcare NHS Trust, London, UK. ¹¹University Hospital Jean Minjoz, Besançon, France. ¹²University Hospital Bordeaux-Hôpital Saint-André, Bordeaux, France. ¹³Fundacion Arturo Lopez Perez FALP, Santiago, Chile. ¹⁴Abramson Cancer Center, Philadelphia, PA, USA. ¹⁵Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun, Poland. ¹⁶Merck & Co., Inc., Kenilworth, NJ, USA. ¹⁷USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA. ¹⁸Royal Free Hospital NHS Trust, University College London, London, UK

Nivolumab/ipilimumab with or without CBM588 in metastatic renal cell carcinoma: a randomized phase Ib study and in-depth analysis of gut microbiome evolution

Nazli Dizman MD¹, Luis Meza MD², Paulo G. Bergerot MD², Tanya B. Dorff MD², Yung Lyou MD, PhD², Paul H. Frankel PhD³, Yujie Cui MSc³, Valerie Mira MPH², Marian Llamas², JoAnn Hsu BSc², Zeynep Busra Zengin MD², Nicholas Salgia BSc², Sabrina Salgia BSc², Jasnoor Malhotra MD², Neal Chawla MD², Alex Chehraz-Raffle MD², Ramya Muddasani DO², John Gillece MSc⁴, Lauren Reining MD⁴, Jeffrey Trent MD⁴, Motomichi Takahashi PhD⁵, Kentaro Oka PhD⁵, Seiya Higashi⁵, Sarah K. Highlander PhD⁴, Sumanta K. Pal MD²

¹Department of Internal Medicine, Yale School of Medicine, Yale New Haven Hospital. ²Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA. ³Department of Biostatistics, City of Hope Comprehensive Cancer Center, Duarte, CA. ⁴The Translational Genomics Research Institute (TGen), Phoenix, AZ. ⁵Miyarisan Pharmaceuticals, Japan

Integrative Clinical and Molecular Characterization of Translocation Renal Cell Carcinoma

Ziad Bakouny MD, MSc¹, Ananthan Sadagopan¹, Praful Ravi¹, Nebiyou Metaferia¹, Jiao Li¹, Shatha AbuHammad¹, Stephen Tang¹, Stephen Tang¹, Thomas Denize², Emma Garner¹, Xin Gao³, David Braun¹, Laure Hirsch¹, John Steinharter¹, Gabrielle Bouchard¹, Emily Walton², Destiny West², Chris Labaki¹, Shaan Dudani⁴, Chun-Loo Gan⁵, Vidyalakshmi Sethunath¹, Filipe Carvalho⁶, Alma Imamovic¹, Cora Ricker¹, Natalie Vokes¹, Jackson Nyman¹, Jacob Berchuck¹, Jihye Park¹, Michelle Hirsch², Rizwan Haq¹, Gwo-Shu Lee¹, Bradley McGregor¹, Steven Chang⁶, Adam Feldman⁷, Catherine Wu¹, David McDermott⁸, Daniel Heng⁵, Sabina Signoretti², Eliezer Van Allen¹, Toni Choueiri¹, Srinivas Viswanathan MD, PhD¹

¹Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. ²Department of Pathology, Brigham and Women's Hospital, Boston, MA, USA. ³Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, MA, USA. ⁴Division of Medical Oncology/Hematology, William Osler Health System, Brampton, ON, Canada. ⁵Division of Medical Oncology, Tom Baker Cancer Centre, University of Calgary, AB, Canada. ⁶Division of Urology, Brigham and Women’s Hospital, Boston, MA, USA. ⁷Department of Urology, Massachusetts General Hospital, Boston, MA, USA. ⁸Beth Israel Deaconess Medical Center, Boston, MA, USA

Abstract Oral Presentations

11:15am - 12:15pm Friday, 8th October, 2021

Breaks Sessions

Moderators and Panelists Rana McKay, Sumanta Pal

A phase 3 trial of lenvatinib plus pembrolizumab versus sunitinib as a first-line treatment for patients with advanced renal cell carcinoma: overall survival follow-up analysis (the CLEAR study)

Characterization of responders in the phase 3 CheckMate 9ER trial: nivolumab plus cabozantinib versus sunitinib in patients with previously untreated advanced renal cell carcinoma

Pembrolizumab (pembro) vs placebo as post nephrectomy adjuvant therapy for patients with renal cell carcinoma (RCC): randomized, double-blind, phase 3 KEYNOTE-564 study

Nivolumab/ipilimumab with or without CBM588 in metastatic renal cell carcinoma: a randomized phase Ib study and in-depth analysis of gut microbiome evolution

Integrative Clinical and Molecular Characterization of Translocation Renal Cell Carcinoma

Generation of an in vivo CRISPR/Cas9-based ccRCC model using AAV