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ASCO G.U. 2014 Lawrence H. Einhorn

ASCO G.U. 2014 Lawrence H. Einhorn. TOPICS Testis cancer – nothing new July 1, 2014 JCO (correspondence) – Albany and Einhorn: Pitfalls in low level elevations of AFP Bladder cancer PD-L1 Renal cell cancer Ranking of treatment options Nivolumab PD-1 Prostate cancer Adjuvant Docetaxel

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ASCO G.U. 2014 Lawrence H. Einhorn

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  1. ASCO G.U. 2014 Lawrence H. Einhorn

  2. TOPICS • Testis cancer – nothing new • July 1, 2014 JCO (correspondence) – Albany and Einhorn: Pitfalls in low level elevations of AFP • Bladder cancer • PD-L1 • Renal cell cancer • Ranking of treatment options • Nivolumab PD-1 • Prostate cancer • Adjuvant Docetaxel • Enzalutamide

  3. Inhibition of PD-L1 by MPDL3280A<br />leads to clinical activity in<br />patients with metastatic urothelial bladder cancer (UBC)

  4. MPDL 3280A PD-L1 I IN METASTATIC BLADDER CA • 65 patients entered • 71% received 2 or more prior therapies • 17 of 65 (26%) response rate, but 13 of 30 (43%) if PD-L1 positive (2+ or 3+) by IHC, including 2 C.R.s • Genentech phase II study to enroll 326 (!!) patients

  5. Renal Cell Cancer

  6. Algorithm for Clear Cell RCC Therapy Presented By Michael Atkins at 2014 ASCO Annual Meeting

  7. Nivolumab for metastatic renal cell <br />carcinoma (mRCC): results of a randomized, dose-ranging phase II trial Presented By Robert Motzer at 2014 ASCO Annual Meeting

  8. Phase II study design Presented By Robert Motzer at 2014 ASCO Annual Meeting

  9. Key inclusion criteria Presented By Robert Motzer at 2014 ASCO Annual Meeting

  10. NIVOLUMAB IN METASTATIC RENAL CELL CA • 168 patients entered; all received prior therapy and 70% 2 or more including VEGF TKIs (98%) MTOR inhibitors (38%) and immunotherapy (24%) • 35 of 168 (21%) response rate; 19 of these 35 (54%) remissions were 12+ month duration

  11. Overall survival Presented By Robert Motzer at 2014 ASCO Annual Meeting

  12. PROSTATE CANCER

  13. ASCO 2004, abstracts 3 and 4<br />mCRPC 2 months improvement in OS

  14. <br /><br />E3805<br />CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer

  15. E3805 – CHAARTED Treatment ADT + Docetaxel x 6 cycles Men with Metastatic Hormone Sensitive Prostate Cancer ADT Alone ADT allowed up to 120 days prior to randomization No Intermittent ADT allowed Primary Endpoint: Overall Survival Secondary Endpoints: PSA response rate, Time to progression, Toxicity QOL.

  16. Primary endpoint: Overall survival N=790 13.6 months

  17. Secondary Endpoints Presented By Christopher Sweeney at 2014 ASCO Annual Meeting

  18. Drugs that prolong OS for CRPC Presented By Michael Morris at 2014 ASCO Annual Meeting

  19. PREVAIL– Study Design Enzalutamide N=872 Men with Metastatic Castration Resistant Prostate Cancer Chemo-naïve N= 1717 Placebo N=845 Co-Primary Endpoint: RadiographicPFS Overall Survival

  20. PREVAIL Was Halted at the Interim Analysis for Significant Benefit with Enzalutamide Presented By Andrew Armstrong at 2014 ASCO Annual Meeting

  21. Enzalutamide Prolonged Radiographic <br />Progression-Free Survival Presented By Andrew Armstrong at 2014 ASCO Annual Meeting

  22. Enzalutamide Reduced Risk of Death by 29% Presented By Andrew Armstrong at 2014 ASCO Annual Meeting

  23. Enzalutamide Delayed Time to PSA Progression Presented By Andrew Armstrong at 2014 ASCO Annual Meeting

  24. SUMMARY • Testis cancer • Bladder cancer • Renal cell cancer • Castrate resistant prostate cancer

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