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

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Presentation transcript:

Slide 1 Presented By Mark Stein at 2014 ASCO Annual Meeting

Slide 2 Presented By Mark Stein at 2014 ASCO Annual Meeting

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

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

Conclusions Presented By Mark Stein at 2014 ASCO Annual Meeting

Slide 6 Presented By Mark Stein at 2014 ASCO Annual Meeting

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

Slide 8 Presented By Mark Stein at 2014 ASCO Annual Meeting

Slide 9 Presented By Mark Stein at 2014 ASCO Annual Meeting

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

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

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

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

Slide 14 Presented By Mark Stein at 2014 ASCO Annual Meeting

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

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

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

Take away Presented By Mark Stein at 2014 ASCO Annual Meeting

Slide 19 Presented By Mark Stein at 2014 ASCO Annual Meeting

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

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

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

Slide 23 Presented By Mark Stein at 2014 ASCO Annual Meeting

Slide 24 Presented By Mark Stein at 2014 ASCO Annual Meeting

Slide 25 Presented By Mark Stein at 2014 ASCO Annual Meeting

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

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

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

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

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

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

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

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

Study design Presented By Mark Stein at 2014 ASCO Annual Meeting

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

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

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

Slide 38 Presented By Mark Stein at 2014 ASCO Annual Meeting

Slide 39 Presented By Mark Stein at 2014 ASCO Annual Meeting

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

Slide 41 Presented By Mark Stein at 2014 ASCO Annual Meeting

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

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

Slide 44 Presented By Mark Stein at 2014 ASCO Annual Meeting

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

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

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

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

Slide 49 Presented By Mark Stein at 2014 ASCO Annual Meeting

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

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

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

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

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

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

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

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

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