ASCO Review- 2015 What is new in breast cancer? Bhuvana Ramaswamy Associate Professor The Ohio State University

1. ASCO Review- 2015
What is new in breast cancer?
Bhuvana Ramaswamy
Associate Professor
The Ohio State University

2. OVERVIEW
• Prevention
• ER Positive
• HER2 Positive
• Triple negative

3. PREVENTION

4. Primary Results of NRG Oncology/NSABP B-35: <br />A Clinical Trial of Anastrozole vs Tamoxifen in <br />Postmenopausal Patients with DCIS
Presented By Richard Margolese at 2015 ASCO Annual Meeting

5. Slide 5
Presented By Richard Margolese at 2015 ASCO Annual Meeting

6. B-35: Patient Population
Presented By Richard Margolese at 2015 ASCO Annual Meeting

7. Slide 12
Presented By Richard Margolese at 2015 ASCO Annual Meeting

8. Slide 13
Presented By Richard Margolese at 2015 ASCO Annual Meeting

9. Slide 14
Presented By Richard Margolese at 2015 ASCO Annual Meeting

10. Slide 15
Presented By Richard Margolese at 2015 ASCO Annual Meeting

11. Slide 17
Presented By Richard Margolese at 2015 ASCO Annual Meeting

12. Slide 26
Presented By Richard Margolese at 2015 ASCO Annual Meeting

13. ESTROGEN RECEPTOR POSITIVE
TUMORS

14. CALGB 40503 (Alliance)/CTSU 40503/NCT00601900<br /><br />Phase III Trial Evaluating the Addition of Bevacizumab to Letrozole As First-line Endocrine Therapy for Treatment of Hormone-receptor Positive
(HR+)<br />Advanced Breast Cancer
Presented By Maura Dickler at 2015 ASCO Annual Meeting

15. Study Design - CALGB (Alliance) 40503<br />Multicenter Randomized Phase III Trial of 1st-line Letrozole +/- Bev
Presented By Maura Dickler at 2015 ASCO Annual Meeting

16. Progression-Free Survival<br />CALGB (Alliance) 40503
Presented By Maura Dickler at 2015 ASCO Annual Meeting

17. Overall Survival<br /> CALGB (Alliance) 40503
Presented By Maura Dickler at 2015 ASCO Annual Meeting

18. Conclusions<br />CALGB (Alliance) 40503
Presented By Maura Dickler at 2015 ASCO Annual Meeting

19. Implications/Future Directions<br />CALGB (Alliance) 40503
Presented By Maura Dickler at 2015 ASCO Annual Meeting

20. Phase III Trials Endocrine Therapy +/- Bevacizumab (open-label)
Presented By Joseph Sparano at 2015 ASCO Annual Meeting

21. Abstract LBA502 <br /><br /> A Double Blind Phase 3 Trial of Fulvestrant With or Without Palbociclib in Pre- and Post-menopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast
Cancer That Progressed on Prior Endocrine Therapy<br />(PALOMA3 Study)
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

22. Slide 2
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

23. Palbociclib
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

24. PALOMA3 Study Design
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

25. PALOMA3 Primary Endpoint: PFS<br /> (Investigator-Assessed) ITT Population
Presented By Joseph Sparano at 2015 ASCO Annual Meeting

26. PALOMA-1: Randomized open-label phase II trial
Presented By Joseph Sparano at 2015 ASCO Annual Meeting

27. Demographics and Baseline Tumor Characteristics
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

28. Tumor Characteristics and Prior Treatment
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

29. Adverse Events—All Cause
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

30. Primary Endpoint: PFS (ITT Population)
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

31. PFS: Central Blinded Review Audit (n=211)
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

32. Summary of Key Secondary Efficacy Endpoints
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

33. Conclusions
Presented By Nicholas Turner at 2015 ASCO Annual Meeting

34. Palbociclib in HR+/HER2– BC: Phase III Studies
Presented By Joseph Sparano at 2015 ASCO Annual Meeting

35. Other CDK Inhibitors in Phase III Trials in Advanced ER-Positive Breast Cancer
Presented By Joseph Sparano at 2015 ASCO Annual Meeting

36. Slide 17
Presented By Joseph Sparano at 2015 ASCO Annual Meeting

37. HER POSITIVE TUMORS

38. L Gianni, T Pienkowski, Y-H Im, L-M Tseng, M-C Liu, A Lluch, <br />E Starosławska, J de la Haba-Rodriguez, S-A Im, JL Pedrini, B Poirier, <br />P Morandi, V Semiglazov, V Srimuninnimit, GV Bianchi, <br />V
McNally, H Douthwaite, G Ross, P Valagussa
Presented By Luca Gianni at 2015 ASCO Annual Meeting

39. NeoSphere: Phase 2 Neoadjuvant HER2+ Study
Presented By Shanu Modi at 2015 ASCO Annual Meeting

40. Slide 5
Presented By Shanu Modi at 2015 ASCO Annual Meeting

41. PFS by tpCR: all treatment arms combined, <br />ITT population
Presented By Luca Gianni at 2015 ASCO Annual Meeting

42. Lower pCR Rates for HR+ HER2+ BC
Presented By Shanu Modi at 2015 ASCO Annual Meeting

43. <br />Oral Abstract Session: <br />Breast Cancer—HER2/ER<br /><br />Substantial efficacy of 12-weeks of neoadjuvant TDM1 with or without endocrine therapy in HER2-positive hormone-receptor-positive early
breast cancer: <br />WSG-ADAPT HER2+/HR+ phase II trial<br />
Presented By Nadia Harbeck at 2015 ASCO Annual Meeting

44. ADAPT HER2+/HR+: <br />Neoadjuvant Phase 2 Trial
Presented By Shanu Modi at 2015 ASCO Annual Meeting

45. 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

46. MARIANNE Study Design
Presented By Shanu Modi at 2015 ASCO Annual Meeting

47. MARIANNE: Progression-Free Survival
Presented By Shanu Modi at 2015 ASCO Annual Meeting

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

49. Clinical Pathway HER2+ MBC: 2015
Presented By Shanu Modi at 2015 ASCO Annual Meeting

50. Neratinib after adjuvant chemotherapy and trastuzumab in HER2-positive early breast cancer: Primary analysis at 2 years of a phase 3 randomized, placebo-controlled trial (ExteNET)
Presented By Arlene Chan at 2015 ASCO Annual Meeting

51. Adjuvant ExteNET Study Design
Presented By Shanu Modi at 2015 ASCO Annual Meeting

52. HERA: OS<br />(Duration Question: 2y vs 1y)
Presented By Shanu Modi at 2015 ASCO Annual Meeting

53. ExteNET Trial: Invasive DFS, N=2840<br />
Presented By Shanu Modi at 2015 ASCO Annual Meeting

54. Is extended therapy with neratinib ready to be a new standard of care?
Presented By Shanu Modi at 2015 ASCO Annual Meeting

55. CONCLUSIONS: HER2+ Breast Cancer
Presented By Shanu Modi at 2015 ASCO Annual Meeting

56. TRIPLE NEGATIVE BREAST CANCER

57. Results from a Phase 2 Study of Enzalutamide, an Androgen Receptor Inhibitor, in Advanced AR+ Triple-Negative Breast Cancer (MDV3100-11)
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

58. Enzalutamide is a Potent Inhibitor of AR Signaling
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

59. AR Signaling and Triple-Negative Breast Cancer
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

60. Study Schema (MDV3100-11)
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

61. Clinical Benefit in Evaluable and ITT Populations
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

62. PFS in Evaluable and ITT Populations
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

63. AR-Driven Biology in Patients
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

64. Clinical Benefit According to PREDICT AR
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

65. A Multi-Covariate Cox-Proportional Hazards Model of PFS
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

66. Overall Survival in TNBC Patients on Enzalutamide and According to PREDICT AR Status
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

67. Conclusions
Presented By Tiffany Traina at 2015 ASCO Annual Meeting

68. Prevalence and predictors of androgen receptor (AR) and programmed death-ligand 1 (PD-L1) expression in BRCA1-associated and sporadic triple negative breast cancer (TNBC) (abstr 1005)
Presented By Nadine Tung at 2015 ASCO Annual Meeting

69. Vanderbilt Subtypes of TNBC
Presented By Nadine Tung at 2015 ASCO Annual Meeting

70. Background: Luminal Androgen Receptor TNBC
Presented By Nadine Tung at 2015 ASCO Annual Meeting

71. Background: Luminal Androgen Receptor TNBC
Presented By Nadine Tung at 2015 ASCO Annual Meeting

72. Programmed death-ligand 1 (PD-L1) in TNBC
Presented By Nadine Tung at 2015 ASCO Annual Meeting

73. PD-L1 in TNBC: Immune Checkpoint Inhibitors
Presented By Nadine Tung at 2015 ASCO Annual Meeting

74. Methods
Presented By Nadine Tung at 2015 ASCO Annual Meeting

75. Immunohistochemical Staining
Presented By Nadine Tung at 2015 ASCO Annual Meeting

76. Conclusions
Presented By Nadine Tung at 2015 ASCO Annual Meeting

77. What Else is Being Clinically Targeted?
Presented By Antoinette Tan at 2015 ASCO Annual Meeting

78. Slide 21
Presented By Antoinette Tan at 2015 ASCO Annual Meeting

79. SUMMARY
• PRACTICE CHANGING
• EXCITING
• JUST FYI
THANK YOU