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Slide 1 Presented By Mark Stein at 2014 ASCO Annual Meeting.

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Presentation on theme: "Slide 1 Presented By Mark Stein at 2014 ASCO Annual Meeting."— Presentation transcript:

1 Slide 1 Presented By Mark Stein at 2014 ASCO Annual Meeting

2 Slide 2 Presented By Mark Stein at 2014 ASCO Annual Meeting

3 The Site of Metastases Predicts Overall Survival in Castration-Resistant Prostate Cancer Patients: A Meta-Analysis of 5 Phase III trials Susan Halabi1, Wm. Kevin Kelly2, Haojin Zhou1, Andrew J. Armstrong1, David I. Quinn3, Karim Fizazi4, Nicole C. Solomon1, Ian F. Tannock5, Daniel P. Petrylak6, Michael J. Morris7, Eric J. Small8 1Duke University, Durham, NC; 2Thomas Jefferson University, Philadelphia, PA; 3University of Southern California, Los Angeles, CA; 4Institut Gustave Roussy, Villejuif, France; 5Princess Margaret Cancer Centre, Toronto, ON, Canada; 6Yale University, New Haven, CT; 7Memorial Sloan Kettering Cancer Center, New York, NY; 8University of California San Francisco, CA Presented By Mark Stein at 2014 ASCO Annual Meeting

4 Patient Population (N=3,993) Presented By Mark Stein at 2014 ASCO Annual Meeting

5 Conclusions Presented By Mark Stein at 2014 ASCO Annual Meeting

6 Slide 6 Presented By Mark Stein at 2014 ASCO Annual Meeting

7 PHASE iii TRIALS OF Ar targeting agents PRE-ASCO 2014 Presented By Mark Stein at 2014 ASCO Annual Meeting

8 Slide 8 Presented By Mark Stein at 2014 ASCO Annual Meeting

9 Slide 9 Presented By Mark Stein at 2014 ASCO Annual Meeting

10 Primary, Secondary and Quality-of-Life Endpoint Results from PREVAIL, a Phase 3 Study of Enzalutamide in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Presented By Mark Stein at 2014 ASCO Annual Meeting

11 PREVAIL: A Phase 3 Trial of Enzalutamide After Progression on Androgen Deprivation Therapy in Men with Metastatic Prostate Cancer Presented By Mark Stein at 2014 ASCO Annual Meeting

12 Treatment Groups Were Well Balanced for Baseline Patient Characteristics/Disease burden Presented By Mark Stein at 2014 ASCO Annual Meeting

13 PHASE iii TRIALS OF Ar targeting agents PRE-ASCO 2014 Presented By Mark Stein at 2014 ASCO Annual Meeting

14 Slide 14 Presented By Mark Stein at 2014 ASCO Annual Meeting

15 Quality-of-Life Responses by FACT-P Presented By Mark Stein at 2014 ASCO Annual Meeting

16 Most Common Adverse Events* Presented By Mark Stein at 2014 ASCO Annual Meeting

17 Enzalutamide Had a High PSA Response Rate Presented By Mark Stein at 2014 ASCO Annual Meeting

18 Take away Presented By Mark Stein at 2014 ASCO Annual Meeting

19 Slide 19 Presented By Mark Stein at 2014 ASCO Annual Meeting

20 Orteronel (TAK-700) is an investigational, non-steroidal, reversible, relatively selective inhibitor of 17,20-lyase Presented By Mark Stein at 2014 ASCO Annual Meeting

21 PHASE iii TRIALS OF Ar targeting agents PRE-ASCO 2014 Presented By Mark Stein at 2014 ASCO Annual Meeting

22 Phase 3, randomized, placebo-controlled trial of orteronel (TAK-700) plus prednisone in patients (pts) with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) (ELM-PC 4 trial) Presented By Mark Stein at 2014 ASCO Annual Meeting

23 Slide 23 Presented By Mark Stein at 2014 ASCO Annual Meeting

24 Slide 24 Presented By Mark Stein at 2014 ASCO Annual Meeting

25 Slide 25 Presented By Mark Stein at 2014 ASCO Annual Meeting

26 Mechanisms of resistance to AR inhibition Presented By Mark Stein at 2014 ASCO Annual Meeting

27 AR Splice Variants (AR-Vs) Presented By Mark Stein at 2014 ASCO Annual Meeting

28 Androgen Receptor Splice Variant-7 (AR-V7) and Resistance to Enzalutamide and Abiraterone in Men with Metastatic Castration-Resistant Prostate Cancer Presented By Mark Stein at 2014 ASCO Annual Meeting

29 Prospective Biomarker Study with CTC based AR-V7 assay by RT-PCR Presented By Mark Stein at 2014 ASCO Annual Meeting

30 Results: AR-V7 prevalence Presented By Mark Stein at 2014 ASCO Annual Meeting

31 Take home: Presented By Mark Stein at 2014 ASCO Annual Meeting

32 Enzalutamide in combination with Abiraterone Acetate in bone metastatic Castration Resistant Prostate Cancer Presented By Mark Stein at 2014 ASCO Annual Meeting

33 Mechanisms of resistance to AR inhibition Presented By Mark Stein at 2014 ASCO Annual Meeting

34 Study design Presented By Mark Stein at 2014 ASCO Annual Meeting

35 Results: Abiraterone plus Enzalutamide Presented By Mark Stein at 2014 ASCO Annual Meeting

36 Abiraterone plus Enzalutamide: Tissue Markers of response Presented By Mark Stein at 2014 ASCO Annual Meeting

37 Take away: Alliance A031201 (PI: M Morris) Presented By Mark Stein at 2014 ASCO Annual Meeting

38 Slide 38 Presented By Mark Stein at 2014 ASCO Annual Meeting

39 Slide 39 Presented By Mark Stein at 2014 ASCO Annual Meeting

40 Docetaxel-estramustine in localized high- risk prostate cancer: Results of the French Genito-Urinary Tumor Group GETUG 12 phase III trial Presented By Mark Stein at 2014 ASCO Annual Meeting

41 Slide 41 Presented By Mark Stein at 2014 ASCO Annual Meeting

42 Progression-free survival Presented By Mark Stein at 2014 ASCO Annual Meeting

43 Additional data from early disease trials +/- docetaxel awaited Presented By Mark Stein at 2014 ASCO Annual Meeting

44 Slide 44 Presented By Mark Stein at 2014 ASCO Annual Meeting

45 Problem of PSA recurrence Presented By Mark Stein at 2014 ASCO Annual Meeting

46 Immediate vs. deferred initiation of androgen deprivation therapy in prostate cancer patients with PSA-only relapse. An observational follow-up study Presented By Mark Stein at 2014 ASCO Annual Meeting

47 Methods. Study design. Presented By Mark Stein at 2014 ASCO Annual Meeting

48 Take-away Presented By Mark Stein at 2014 ASCO Annual Meeting

49 Slide 49 Presented By Mark Stein at 2014 ASCO Annual Meeting

50 E3805 CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer Presented By Mark Stein at 2014 ASCO Annual Meeting

51 Early Chemo-HT: Hypothesis Presented By Mark Stein at 2014 ASCO Annual Meeting

52 E3805 – CHAARTED early chemotherapy Presented By Mark Stein at 2014 ASCO Annual Meeting

53 High volume disease Presented By Mark Stein at 2014 ASCO Annual Meeting

54 Summary of results (med f/u 29 mo’s): mCSPC Presented By Mark Stein at 2014 ASCO Annual Meeting

55 Overall survival by volume of mets at start of ADT Presented By Mark Stein at 2014 ASCO Annual Meeting

56 Drugs that prolong OS for CRPC Presented By Mark Stein at 2014 ASCO Annual Meeting

57 Take-away Presented By Mark Stein at 2014 ASCO Annual Meeting

58 Take-away Presented By Mark Stein at 2014 ASCO Annual Meeting


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