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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.

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Presentation on theme: "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."— Presentation transcript:

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 leads to clinical activity in 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 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 TKI s (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 mCRPC 2 months improvement in OS

14 E3805 CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer

15 E3805 – CHAARTED Treatment Men with Metastatic Hormone Sensitive Prostate Cancer ADT + Docetaxel x 6 cycles 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 Men with Metastatic Castration Resistant Prostate Cancer Chemo-naïve N= 1717 Enzalutamide N=872 Placebo N=845 Co-Primary Endpoint: Radiographic PFS 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 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

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25 SUMMARY Testis cancer Bladder cancer Renal cell cancer Castrate resistant prostate cancer


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