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“The following presentation should not be regarded as an endorsement of a particular product/drug/technique by the speaker. The presentation topics were assigned to the speakers by the scientific committee of the KCA, to be presented/interpreted as part of a comprehensive scientific debate. Therefore, this presentation should not be viewed/interpreted in isolation, and should be considered in context with the other presentations in the same session. " Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Nivolumab as a second-line therapy for metastatic RCC Saby George, MD, FACP Associate Professor of Medicine and Oncology Genitourinary Oncology Program Roswell Park Cancer Institute 11/05/2016 Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Disclosures I have consulted/ worked in a scientific advisory role for Astellas Bayer Bristol-Myers Squibb Novartis Onclive Pfizer Sanofi Xcenda Exelixis I have received research funding from Agensys Acceleron Bayer Bristol-Myers Squibb Novartis Pfizer Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Previously Treated RCC: What's Best? Phase III Checkmate-025 data Efficacy Safety QOL improvement TBP and examples of long term benefit McDermott data (ASCO 2016) Comparative and contrast Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA Sharma et al. ESMO 2015 www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA Sharma et al. ESMO 2015 www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA Sharma et al. ESMO 2015 www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA Sharma et al. ESMO 2015 www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com 11/2011 8/2016 This 67 year old lady was on Nivolumab (CA209010) trial and got treated for 2 years. Then she discontinued Nivolumab nearly 3 years ago and maintained the complete response. Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA George S et al. ESMO 2015 www.kidneycancersymposium.com Patient YY 11/2011 1/2012 Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com 1/2012 3/2015 This 52 year old man went on to have a CR and is maintaining CR nearly 5 years after initiating Nivolumab. Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA George S et al. ESMO 2015 www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA George S et al. ESMO 2015 www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA George S et al. ESMO 2015 www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA George S et al. ESMO 2015 www.kidneycancersymposium.com Checkmate-025 Treatment Beyond Progression Escudier et al . Checkmate 025 TBP. ASCO 2016. Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Tumor Burden Changes With Nivolumab According to Best Overall Response Escudier et al . Checkmate 025 TBP. ASCO 2016. Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Overall Survival with TBP vs NTBP Escudier et al . Checkmate 025 TBP. ASCO 2016. Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Long term/ durable benefit from Nivolumab Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Comparative efficacy/ safety data Nivolumab (Checkmate 025) Phase III ORR (%) Cabozantinib (Meteor) PHASE III Lenvatinib + Everolimus PHASE II Axitinib (Axis) PHASE III 25 17 30 19 AE grade 3+4 (%) 19 68 71 NA (54% required dose interruptions ) Discontinuation rates due to TRAE (%) 8 12 24 4 OS (Months) 25 21.4 25.5 20.1 (NS) QOL Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Summary • The Checkmate-025 trial demonstrated the efficacy of Nivolumab in Treatment refractory RCC population • The safety profile has been established by phase I/ II trials and it has been confirmed by the larger trial-025 • The fact that the QOL improves after starting Nivolumab attests to the fact that in addition to the safety and efficacy, patients feels better when they are treated with Nivolumab • McDermott data demonstrates long term durable benefit leading to OS advantage from Nivolumab in a vast majority of patients • Moreover, after being on a TKI for a long time in the first-line setting, it is better to give them a break from this class of drugs • Nivolumab is the best second line therapy for mRCC after prior TKI use. Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com Acknowledgements • Mentors: • Brian Rini, MD and Ronald Bukowski, MD • Colleagues: • David McDermott, MD • Pam Sharma, MD • Robert Motzer, MD • BMS (slide provision) • Patients and the coordinators • KCA Fifteenth International Kidney Cancer Symposium November 4-5, 2016 Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com