ACROSS ONCOLOGY. WORLDWIDE

Josep TaberneroESMO President

Friday, 22 March 2019

ESMO

DECLARATION OF INTEREST

Josep Tabernero reports personal financial interest in form of scientific consultancy role for Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Inc., Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Partners, Novartis, Peptomyc, Pfizer, Pharmacyclics, ProteoDesign SL, Rafael Pharmaceuticals, F. Hoffmann-La Roche Ltd, Sanofi, SeaGen, Seattle Genetics, Servier, Symphogen, Taiho, VCN Biosciences, Biocartis, Foundation Medicine, HalioDX SAS and Roche Diagnostics.

Josep Tabernero declares institutional financial interest in form of financial support for clinical trials or contracted research for Agendia BV, Amgen SA, Debiopharm International SA, Janssen-Cilag SA, Mologen AG, Novartis Farmacéutica SA, Pharma Mar, Roche Farma SA, LaboratoriosServier SL and Symphogen A/S.

ESMO IN A NUTSHELLAcross oncology. Worldwide

ESMO is the leading European professional organisation for medical oncology, working across Europe and around the world to erase boundaries in cancer care and to provide medical oncology education within an integrated approach to cancer

care

ESMO MISSION

ESMO 2020 VISIONSecuring the best possible outcomes for people with cancer

ESMO PRIORITIES

ESMO MEMBERSA global community

>20,000 members

150 countries

Reciprocity agreements with 41 national oncology societies

ESMO MEMBERS IN LATIN AMERICA1,418 members from 29 countries

Figures as at 31 December 2018

+21% increase from 2017+150% increase over last 5 years+254% increase over last 10 years

Latin AmericaBrazil 436 Honduras 7Mexico 332 Jamaica 5Argentina 167 Venezuela 5Peru 119 Nicaragua 4Colombia 93 Bahamas 3Chile 51 Curacao 3Cuba 24 Trinidad Tobago 3Costa Rica 21 Guadeloupe 2Dominican Rep. 19 Guyana 2Uruguay 19 Barbados 1Bolivia 17 Belize 1Paraguay 15 Haiti 1El Salvador 13 Martinique 1Panama 13 Suriname 1Guatemala 10 TOT 1,418

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018Latin America 400 513 439 466 341 568 736 877 1174 1418

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200

400

600

800

1000

1200

1400

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# Act

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Latin America - MBS Trend 2009-2018

ONCOLOGYPROAccess to essential and updated resources anywhere, anytime

Daily news E-learning modules Slide sets Full access articles ESMO books Webcasts

ESMO’S JOURNALSEnsuring that advances in oncology are rapidly disseminated worldwide

ESMO CLINICAL PRACTICE GUIDELINESProviding oncology professionals with recommendations for the best standards of cancer care

Latest recommendations for diagnosis, disease

staging, risk assessment, treatment and follow-up

Regularly updated and reviewed by leading

oncology experts

>75 guidelines available from the ESMO website, OncologyPRO. Abridged versions available on the ESMO guidelines mobile

apps

> 20 patient friendly versions available on the

ESMO website, in different languages

ESMO MEETINGSIn 2018, nearly 36,000 oncology stakeholders met through ESMO’s events

EuropeESMO Congress

5 congresses3 symposia

4 educational courses14 preceptorships

AfricaESMO Summit Africa

ESMO Summit Middle East

AsiaESMO Asia Congress

7 preceptorships

ENSURING SUSTAINABLE CANCER CARELooking to the future for issues affecting all oncology professionals

Cancer Medicines Committee

Expensive, innovative cancer medicines

It aims to develop an economic model to tackle

issues related to reimbursement of

innovative medicines

Cancer Medicines Committee

Inexpensive, essential cancer medicines

Report on Cancer Medicines Shortages in Europe developed with

The Economist Intelligence Unit.

Recommendations made to policy makers on how to prevent and manage

shortages

ESMO-MCBS

Designed to assess the therapeutic benefit of

drugs registered for the treatment of cancer

Biosimilars

Tailored educational material for oncologists &

patientsESMO Colloquia on

biosimilars during ESMO 2018 & ESMO Asia 2018European Commission

2018 Stakeholder Event on Biosimilar Medicinal

Products

Magnitude of Clinical Benefit

Overall Survival,

Progression Free Survival

Toxicity

Costs

Prognosis of condition

Quality of lifeHR,

Long term survival,RR

Not analysed in view of significant “Heterogeneity”across Europe

ESMO-MCBS Factors taken into account

Metastatic NSCLC

aEMA approvals in 2016 to end August 2016. bESMO-MCBS version 1.0 [181], cEMA approval, October 2015dCo-primary end points (overall survival and progression-free survival both in the total population and in patients with PD-L1 expression on at least 50% of tumour cells)

Therapy Disease setting

Trial Control Absolute survival gain HR(95% CI)

QoL/toxicity

MCBS scoreb

Nivolumab Advanced Nivolumab versus docetaxel in advanced squamous-cell NSCLC [98]

Phase III

NCT01642004

Docetaxel in patients with advanced SCC who have disease progression during or after 1st-line chemotherapy. Control OS 6 months

OS gain: 3.2 months. 2-year survival gain 15%

OS: HR for death 0.59 (0.44-0.79)

Improved toxicity profile

5(Form 2a)c

Nivolumab Advanced Nivolumab versus docetaxel in advanced non-squamous NSCLC [104] Phase IIINCT01673867

Docetaxel in patients with NSCC who progressed during or after platinum-based doublet chemotherapy. Control OS 9.4 months

OS gain: 2.8 months. 2-year survival gain 16%

OS: HR for death0.73 (0.59-0.89)

Improved toxicity profile

5(Form 2a)

Ramucirumab Advanced Ramucirumab plus docetaxel vs placebo + docetaxel for 2nd-line treatment of stage IV NSCLC after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial [94]Phase IIINCT01168973

Placebo + docetaxel in patients with SCC or NSCC who progressed during or after a 1st-line platinum-based chemotherapy regimen. Control OS 9.1 months

OS gain: 1.4 months OS: HR for death 0.86 (0.75-0.98)

Deteriorated toxicity profile

1(Form 2a)

Pembrolizumab Advanced Pembrolizumab vs docetaxel for previously treated, PD-L1-positive, advanced NSCLC (KEYNOTE-010): a randomised controlled trial [96]Phase IIINCT01905657

Docetaxel in patients with previously treated,PD-L1-positive, advanced NSCLC. Control OS 8.5 months

In PD-L1 >1%:dOS gain: 1.9 monthsIn PD- L1 >50%:d

OS gain: 6.7 months

In PD-L1 >1%:dOS: HR for death 0.71 (0.58–0.88)In PD-L1 >50%:d

OS: HR for death 0.54 (0.38–0.77)

Improved toxicity profile

In PD-L1 >1%: 3(Form 2a)In PD-L1 >50%: 5

(Form 2a)

ESMO-MCBS, SUBSTANTIAL IMPROVEMENTSESMO-MCBS – inclusion of scores in Guidelines

Distribution ESMO-MCBS grades FDA approved solid tumour drugs in 2015-2016

ESMO-MCBSSubstantial improvements

Limited clinical benefit of several anticancer agents approved by FDA in 2015–2016 according to ESMO-MCBS

Vivot et al, Ann Oncol 2017

No relation between price and clinical benefit of 38 FDA approved anticancer drugs 2000-2015

CHALLENGES & OPPORTUNITIES:MAJOR VALUE-BASED FRAMEWORKS -UPHOLDING PROVEN AS OPPOSED TO PROMISING

ESMO in action:Expensive Innovative Cancer Medicines

Outline of the model: Reimbursement based on local-referenced value

Value of “X” drug(tumor type/setting)

HE parametersMCBSFrequency of the disease

Adapt to the country/region level

Country/Region parameters:GDP% of GDP in health expendituresFrequency of the disease (registries, extrapolation)

Planned Outcome:•Models and Tools (template) •No specific discussions on specific drugs/regions Geographically-adapted value-based reimbursement

DELIVERING ON ESMO’S MISSION OF FACILITATING EQUAL ACCESS TO OPTIMAL CANCER CARE TO ALL CANCER PATIENTS

ESMO SUMMIT LATIN AMERICAMedical oncology education brought directly to you

We are here to listen to you!

ESMO SUMMIT LATIN AMERICA 2019 Sao Paulo, Brazil, 22-24 March 2019

Oncology Updates: From Evidence to Practice

Designed to address the specific challenges faced by oncology professionals practising in this

region

Local and international experts covering the cancer types most frequently encountered in Latin

America

Series of clinical case presentations followed by time for

discussion

To provide the oncology community with a summary of the most significant treatment advances presented at the ESMOcongresses

To review the current standard of care for key malignancies from a local and international perspective

To discuss the current controversies in the management of specific cancers

PARTICIPANTS OVERVIEWESMO Latin America 2019

26 Speakers and Chairs

333 Delegates

DELEGATESCountry breakdown Country Nr. of delegates

Brazil 293Mexico 9Chile 6Peru 3Uzbekistan 3Costa Rica 3El Salvador 2Ghana 2United States 2Argentina 1Australia 1Belgium 1Bolivia 1Canada 1Eritrea 1Japan 1Nigeria 1Philippines 1Syrian Arab Republic 1

333

87,99% Brazil

7,51% Rest of Latin America

0,30% Europe

4,20% Other

JOIN THE ESMO COMMUNITY TODAY

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FREE MEMBERSHIP OFFERSUMMIT LATIN AMERICA DELEGATES