ASCO 2018 Breast Cancer updates. June 29 th 2018 Einav Gal-Yam Sheba MC

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1 ASCO 2018 Breast Cancer updates June 29 th 2018 Einav Gal-Yam Sheba MC

2 Early BC

3 Adjuvant Chemotherapy benefit in HR-pos Nneg BC TAILORX

4 Slide 1 Presented By Joseph Sparano at 2018 ASCO Annual Meeting

5 TAILORx Presented By Lisa Carey at 2018 ASCO Annual Meeting

6 TAILORx Randomized Trial Presented By Lisa Carey at 2018 ASCO Annual Meeting

7 What We Knew Already: <br />RS < 11 has Great Prognosis with ET alone Presented By Lisa Carey at 2018 ASCO Annual Meeting

8 Primary Endpoint: idfs in 7.5y Presented By Lisa Carey at 2018 ASCO Annual Meeting

9 Slide 12 Presented By Joseph Sparano at 2018 ASCO Annual Meeting

10 Interesting Exploratory<br />Analyses<br />Randomized <br />Arms Presented By Lisa Carey at 2018 ASCO Annual Meeting

11 Slide 14 Presented By Joseph Sparano at 2018 ASCO Annual Meeting

12 Interesting Exploratory<br />Analyses Presented By Lisa Carey at 2018 ASCO Annual Meeting

13 TAILORx Results: Summary Presented By Joseph Sparano at 2018 ASCO Annual Meeting

14 How Does This Affect Practice Tomorrow?<br />(for node-negative patients appropriate for chemo) Presented By Lisa Carey at 2018 ASCO Annual Meeting

15 Endocrine therapy in premenopausal women ASTRRA SOFT/TEXT updates

16 Role of adding ovarian function suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or resume menstruation after chemotherapy: the ASTRRA study Presented By Woo Chul Noh at 2018 ASCO Annual Meeting

17 Disease free survival (Primary Endpoint) Presented By Woo Chul Noh at 2018 ASCO Annual Meeting

18 Overall Survival (Secondary Endpoint) Presented By Woo Chul Noh at 2018 ASCO Annual Meeting

19 Slide 1 Presented By Meredith Regan at 2018 ASCO Annual Meeting

20 Premenopausal Adjuvant Endocrine Therapy Presented By Meredith Regan at 2018 ASCO Annual Meeting

21 Slide 7 Presented By Meredith Regan at 2018 ASCO Annual Meeting

22 Presented By Meredith Regan at 2018 ASCO Annual Meeting

23 Presented By David Cameron at 2018 ASCO Annual Meeting

24 Duration of adjuvant Trastuzumab

25 PERSEPHONE: 6 versus 12 months of adjuvant trastuzumab in patients with HER2 positive early breast cancer: Randomised phase 3 non-inferiority trial with definitive 4-year disease-free survival results Presented By Helena Earl at 2018 ASCO Annual Meeting

26 Persephone Study Design Presented By Helena Earl at 2018 ASCO Annual Meeting

27 Disease-free survival Presented By Helena Earl at 2018 ASCO Annual Meeting

28 DFS:<br /><br />Pre-defined subgroup analysis Presented By Helena Earl at 2018 ASCO Annual Meeting

29 Overall survival Presented By Helena Earl at 2018 ASCO Annual Meeting

30 OS:<br /><br />Pre-defined subgroup analysis Presented By Helena Earl at 2018 ASCO Annual Meeting

31 Cardiotoxicity However, only 1 time point was examined for the 12 m patients Presented By Helena Earl at 2018 ASCO Annual Meeting

32 Slide 20 Presented By Martine Piccart-Gebhart at 2018 ASCO Annual Meeting

33

34 Slide 22 Presented By Martine Piccart-Gebhart at 2018 ASCO Annual Meeting

35 Slide 23 Presented By Martine Piccart-Gebhart at 2018 ASCO Annual Meeting

36 Slide 25 Conclusions: Further work needed to reliably identify subgroup for which shorter durations could become SOC. Research is mostly directed at de escalating chemotherapy. (Taxane only fared better with 12 m). Reassure patients that need to stop trastuzumab d/t various reasons ( cardiotoxicity, financial toxicity). Unknown interaction with the expanded use of Pertuzumab. Presented By Martine Piccart-Gebhart at 2018 ASCO Annual Meeting

37 BRCA Mutation Carriers

38 Neoadjuvant Talazoparib for Early Stage Breast Cancer Patients with a BRCA Mutation Presented By Jennifer Litton at 2018 ASCO Annual Meeting

39 Study Design Presented By Jennifer Litton at 2018 ASCO Annual Meeting

40 Slide 6 Presented By Martine Piccart-Gebhart at 2018 ASCO Annual Meeting

41 Slide 7 Presented By Martine Piccart-Gebhart at 2018 ASCO Annual Meeting

42 Toxicities Hematologic Presented By Jennifer Litton at 2018 ASCO Annual Meeting

43 Presented By Martine Piccart-Gebhart at 2018 ASCO Annual Meeting

44 Slide 8 Presented By Martine Piccart-Gebhart at 2018 ASCO Annual Meeting

45 Metastatic BC

46 HR positive CDK4 inh

47 Ribociclib + fulvestrant in postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer: Results from MONALEESA-3 Presented By Dennis Slamon at 2018 ASCO Annual Meeting

48 MONALEESA-3: Phase III placebo-controlled study of ribociclib + fulvestrant Presented By Dennis Slamon at 2018 ASCO Annual Meeting

49 Slide 11 Presented By Dennis Slamon at 2018 ASCO Annual Meeting

50 PFS by prior endocrine therapy status Presented By Dennis Slamon at 2018 ASCO Annual Meeting

51 First line setting Presented By Angela DeMichele at 2018 ASCO Annual Meeting

52 Progression after endocrine therapy Presented By Angela DeMichele at 2018 ASCO Annual Meeting

53 Active in premenopausal patients, regardless of endocrine therapy used Presented By Angela DeMichele at 2018 ASCO Annual Meeting

54 PI3K-AKT-MTOR pathway inhibition

55 Breast cancer and PI3K/AKT pathway Presented By Rebecca Dent at 2018 ASCO Annual Meeting

56 PIK3CA inhibition SANDPIPER Presented By Cynthia Ma at 2018 ASCO Annual Meeting

57 SANDPIPER Efficacy Data Presented By Cynthia Ma at 2018 ASCO Annual Meeting

58 Slide 11 Presented By Cynthia Ma at 2018 ASCO Annual Meeting

59 Slide 12 Presented By Cynthia Ma at 2018 ASCO Annual Meeting

60 Take Home from SANDPIPER: Presented By Cynthia Ma at 2018 ASCO Annual Meeting

61 AKT inhibition ( triple negative) Presented By Rebecca Dent at 2018 ASCO Annual Meeting

62 LOTUS (NCT ) randomized phase II trial Presented By Rebecca Dent at 2018 ASCO Annual Meeting

63 Primary analysis: IPAT effect on PFS enhanced in PIK3CA/AKT1/PTEN-altered subgroup (Foundation Medicinea) Presented By Rebecca Dent at 2018 ASCO Annual Meeting

64 HR:0.62 OS in the ITT population Presented By Rebecca Dent at 2018 ASCO Annual Meeting

65 Updated safety: Most commona adverse events (all grades) Presented By Rebecca Dent at 2018 ASCO Annual Meeting

66 PAKT:<br />A randomised, double-blind, placebo-controlled, phase II trial Presented By Cynthia Ma at 2018 ASCO Annual Meeting

67 PAKT: Presented By Cynthia Ma at 2018 ASCO Annual Meeting

68 Slide 20 Presented By Cynthia Ma at 2018 ASCO Annual Meeting

69 AKT inhibitor in TNBC Presented By Cynthia Ma at 2018 ASCO Annual Meeting

70 Antibody Drug Conjugates

71 Efficacy of sacituzumab govitecan (anti-trop-2-sn-38 antibody-drug conjugate) for treatment-refractory hormone-receptor positive (HR+)/HER2 negative metastatic breast cancer (mbc) Presented By Aditya Bardia at 2018 ASCO Annual Meeting

72 Immu-132 Sacituzumab Govitecan <br />Antibody-Drug Conjugate (ADC) Presented By Aditya Bardia at 2018 ASCO Annual Meeting

73 Single-Arm, Open-Label Study Design Presented By Aditya Bardia at 2018 ASCO Annual Meeting

74 Tumor Response to Sacituzumab Govitecan Presented By Aditya Bardia at 2018 ASCO Annual Meeting

75 Response Onset and Durability (N=17) Presented By Aditya Bardia at 2018 ASCO Annual Meeting

76 Response to Sacituzumab Govitecan in Subgroups Presented By Aditya Bardia at 2018 ASCO Annual Meeting

77 Adverse Events (Regardless of Causality) <br />All events >20% or Grade 3+ >5% Presented By Aditya Bardia at 2018 ASCO Annual Meeting

78 Slide 16 Presented By Aditya Bardia at 2018 ASCO Annual Meeting

79

80

81 Utidelone plus capecitabine vs capecitabine for anthracycline- and taxane-refractory MBC Presented By Binghe Xu at 2018 ASCO Annual Meeting

82 Flow Chart for BG L Presented By Binghe Xu at 2018 ASCO Annual Meeting

83 PFS per IRRC FAS Presented By Binghe Xu at 2018 ASCO Annual Meeting

84 Slide 12 Presented By Binghe Xu at 2018 ASCO Annual Meeting

85 Conclusions Presented By Binghe Xu at 2018 ASCO Annual Meeting

86 Adjuvant Denosumab

87 EBCTCG Meta-analyses of Adjuvant bisphosphonate treatment in early breast cancer: The Lancet Volume 386, Issue 10001, Pages Presented By David Cameron at 2018 ASCO Annual Meeting

88 Denosumab Presented By David Cameron at 2018 ASCO Annual Meeting

89 Adjuvant Denosumab In Early Breast Cancer First Results From The International Multicenter Randomized Phase III Placebo-controlled D-CARE Study Presented By Robert Coleman at 2018 ASCO Annual Meeting

90 D-CARE Study Design Presented By Robert Coleman at 2018 ASCO Annual Meeting

91 Presented By Robert Coleman at 2018 ASCO Annual Meeting 40% of the primary end points were deaths

92 Exploratory Endpoints Presented By Robert Coleman at 2018 ASCO Annual Meeting

93 Osteonecrosis Of Jaw (ONJ) Presented By Robert Coleman at 2018 ASCO Annual Meeting

94 Conclusions Presented By Robert Coleman at 2018 ASCO Annual Meeting

95 Key points Presented By David Cameron at 2018 ASCO Annual Meeting

96 Slide 7 Presented By David Cameron at 2018 ASCO Annual Meeting

97 Slide 1 Presented By Michael Gnant at 2018 ASCO Annual Meeting

98 Slide 3 Presented By Michael Gnant at 2018 ASCO Annual Meeting

99 Slide 4 Presented By Michael Gnant at 2018 ASCO Annual Meeting

100 Slide 7 Presented By Michael Gnant at 2018 ASCO Annual Meeting

101 Slide 14 Presented By Michael Gnant at 2018 ASCO Annual Meeting

102 Slide 16 Presented By Michael Gnant at 2018 ASCO Annual Meeting

103 Slide 20 Presented By Michael Gnant at 2018 ASCO Annual Meeting

104 Slide 8 Presented By David Cameron at 2018 ASCO Annual Meeting

105 Key points Presented By David Cameron at 2018 ASCO Annual Meeting

106 Conclusions Presented By David Cameron at 2018 ASCO Annual Meeting

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