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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?

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

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
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