Fifteenth International Kidney Cancer Symposium - … · Saby George, MD, FACP Associate ... Bayer Bristol-Myers ... Fifteenth International Kidney Cancer Symposium November 4-5,

Fifteenth International Kidney Cancer Symposium

November 4-5, 2016

Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.com

“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. "


November 4-5, 2016


Nivolumab as a second-line therapy for metastatic RCC

Saby George, MD, FACP

Associate Professor of Medicine and OncologyGenitourinary Oncology Program

Roswell Park Cancer Institute11/05/2016


November 4-5, 2016


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


November 4-5, 2016


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


November 4-5, 2016

Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comSharma et al. ESMO 2015


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11/2011 8/2016

Patient XX

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.


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Marriott Miami Biscayne Bay, Miami, Florida, USA www.kidneycancersymposium.comGeorge S et al. ESMO 2015


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11/2011 1/2012

Patient YY


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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.


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Checkmate-025 Treatment Beyond Progression

Escudier et al . Checkmate 025 TBP. ASCO 2016.


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Tumor Burden Changes With Nivolumab According to

Best Overall Response



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Overall Survival with TBP vs NTBP



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Long term/ durable benefit from Nivolumab


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Comparative efficacy/ safety data

Nivolumab

(Checkmate 025)

Phase III

Cabozantinib

(Meteor)

PHASE III

Lenvatinib +

Everolimus

PHASE II

Axitinib

(Axis)

PHASE III

ORR (%) 25 17 30 19

QOL

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)


November 4-5, 2016


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.


November 4-5, 2016


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 - … · Saby George, MD, FACP Associate ... Bayer Bristol-Myers ... Fifteenth International Kidney Cancer Symposium November 4-5,

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