GU Malignancy
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 • Enzalutamide Inhibition of PD-L1 by MPDL3280A<br />leads to clinical activity in<br />patients with metastatic urothelial bladder cancer (UBC) 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 Renal Cell Cancer Algorithm for Clear Cell RCC Therapy Presented By Michael Atkins at 2014 ASCO Annual Meeting 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 Phase II study design Presented By Robert Motzer at 2014 ASCO Annual Meeting Key inclusion criteria Presented By Robert Motzer at 2014 ASCO Annual Meeting 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 Overall survival Presented By Robert Motzer at 2014 ASCO Annual Meeting PROSTATE CANCER ASCO 2004, abstracts 3 and 4<br />mCRPC 2 months improvement in OS <br /><br />E3805<br />CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer 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. N=790 Primary endpoint: Overall survival 13.6 months Secondary Endpoints Presented By Christopher Sweeney at 2014 ASCO Annual Meeting Drugs that prolong OS for CRPC Presented By Michael Morris at 2014 ASCO Annual Meeting PREVAIL– Study Design Men with Metastatic Castration Resistant Prostate Cancer Chemo-naïve N= 1717 Co-Primary Endpoint: Radiographic PFS Overall Survival Enzalutamide N=872 Placebo N=845 PREVAIL Was Halted at the Interim Analysis for Significant Benefit with Enzalutamide Presented By Andrew Armstrong at 2014 ASCO Annual Meeting Enzalutamide Prolonged Radiographic <br />Progression-Free Survival Presented By Andrew Armstrong at 2014 ASCO Annual Meeting Enzalutamide Reduced Risk of Death by 29% Presented By Andrew Armstrong at 2014 ASCO Annual Meeting Enzalutamide Delayed Time to PSA Progression Presented By Andrew Armstrong at 2014 ASCO Annual Meeting SUMMARY • Testis cancer • Bladder cancer • Renal cell cancer • Castrate resistant prostate cancer
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