Gilberto de Lima Lopes, MD, MBA, FAMS Chief Medical and Scientific Officer, Oncoclinicas Group Asst. Prof. of Oncology, Johns Hopkins University

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1 Gilberto de Lima Lopes, MD, MBA, FAMS Chief Medical and Scientific Officer, Oncoclinicas Group Asst. Prof. of Oncology, Johns Hopkins University Assoc. Editor ASCO University and JGO

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3 Progress Against Breast Cancer

5 Progress Against Breast Cancer : More limited mastectomy proven effective for early-stage breast cancer

6 Progress Against Breast Cancer : Doxorubicin active against advanced breast cancer

7 Progress Against Breast Cancer : Adjuvant chemotherapy increases cure rates for early-stage breast cancer

9 Progress Against Breast Cancer : Tamoxifen reduces breast cancer recurrence

11 Progress Against Breast Cancer : First targeted anti-breast cancer drug, trastuzumab (Herceptin), has major impact on care

12 Progress Against Breast Cancer 2000 Present

13 Progress Against Breast Cancer 2000 Present 2007: Lapatinib approved for patients whose HER2-positive breast cancer no longer responds to trastuzumab

14 Progress Against Breast Cancer 2000 Present 2012: Two targeted drugs together are more potent than one for HER-2 positive breast cancer : Armed-antibody drug improves survival for women with resistant HER2 positive cancers

15 % of Patients Surviving Five Years Progress Against Breast Cancer Five-Year Survival Year of Diagnosis Source: National Cancer Institute

16 Cancer Deaths per 100,000 People Progress Against Breast Cancer Mortality Source: National Cancer Institute Year of Death

17 Visit CancerProgress.Net for an interactive timeline of progress against a range of common cancers CancerProgress.Net is a project of the American Society of Clinical Oncology, which represents nearly 30,000 physicians who treat people with cancer and research new cures

18 Conflitos de Interesse em Potencial Verbas de pesquisa e/ou honorários de: EISAI, Eli Lilly, Astra Zeneca, Roche, sanofi aventis, Fresenius Kabi, Merck (MSD), Merck Serono, ASCO, OMS, Agência Internacional de Energia Atômica, Agências dos governos dos EUA, Brasil e Cingapura Não sou acionista ou sócio de nenhuma companhia farmacêutica

19 Phase III, randomized study of trastuzumab emtansine ± pertuzumab vs trastuzumab + taxane for first-line treatment of HER2-positive MBC: Primary results from the MARIANNE study Presented By Paul Ellis at 2015 ASCO Annual Meeting

20 T-DM1 and Pertuzumab Mechanisms of Action Presented By Paul Ellis at 2015 ASCO Annual Meeting

21 Pertuzumab and Trastuzumab: Complementary Mechanisms of Action Presented By Shanu Modi at 2014 ASCO Annual Meeting

22 Rationale for MARIANNE Study Design Presented By Paul Ellis at 2015 ASCO Annual Meeting

23 MARIANNE Study Design Presented By Paul Ellis at 2015 ASCO Annual Meeting

24 Statistical Considerations Presented By Paul Ellis at 2015 ASCO Annual Meeting

25 Patient Disposition Presented By Paul Ellis at 2015 ASCO Annual Meeting

26 Baseline Characteristics Presented By Paul Ellis at 2015 ASCO Annual Meeting

27 Prior Systemic Anti-Cancer Therapy Presented By Paul Ellis at 2015 ASCO Annual Meeting

28 Progression-Free Survival by IRF Presented By Paul Ellis at 2015 ASCO Annual Meeting

29 PFS by IRF Subgroup Analysis (T-DM1 vs HT)a Presented By Paul Ellis at 2015 ASCO Annual Meeting

30 Overall Survival (First Interim Analysis) Presented By Paul Ellis at 2015 ASCO Annual Meeting

31 Objective Response and Duration of Response by IRF Presented By Paul Ellis at 2015 ASCO Annual Meeting

32 Maintenance of Health-Related Quality of Life Presented By Paul Ellis at 2015 ASCO Annual Meeting

33 Overview of Adverse Events Presented By Paul Ellis at 2015 ASCO Annual Meeting

34 Grade 3 AEs Occurring in 3% in Any Treatment Arm Presented By Paul Ellis at 2015 ASCO Annual Meeting

35 All-Grade AEs Occurring in >20% of Patients in Any Treatment <br />Arm With >10% Point Difference Between HT and T-DM1 Arms Presented By Paul Ellis at 2015 ASCO Annual Meeting

36 Conclusions Presented By Paul Ellis at 2015 ASCO Annual Meeting

37 Slide 2 Presented By Shanu Modi at 2014 ASCO Annual Meeting

38 Trastuzumab Added to Chemotherapy Improves OS in HER2+ MBC Presented By Shanu Modi at 2014 ASCO Annual Meeting

39 CLEOPATRA study design Presented By Shanu Modi at 2014 ASCO Annual Meeting

40 CLEOPATRA: Significant improvement in PFS and OS with Pertuzumab

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42 HER2 Positive Metastatic Breast Cancer in 2015 Clinical Pathway: HER2 Positive MBC, <br />2013

43 Conclusions: Treatment of Advanced HER2+ Disease Trastumab improves outcomes when added to chemotherapy in first line Pertuzumab improves survival when added to taxane + trastuzumab in the first line TDM1 improves outcomes when compared to capecitabine + lapatinib after trastuzumab failure Lapatinib + capecitabine, continuation of trastuzumab are options beyond that

44 Muito Obrigado Perguntas? Gilberto Lopes