Challenging Genitourinary Tumors: What s New in 2017
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1 Challenging Genitourinary Tumors: What s New in 2017 David J. Vaughn, MD Genitourinary Medical Oncology Professor Please note that some of the studies reported in this presentation were presented as an abstract and/or presented at a national conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
2 Practice Changing Developments Prostate Cancer Abiraterone acetate improves overall survival when added to androgen-deprivation therapy in high risk metastatic castration-sensitive prostate cancer and is the new standard of care Bladder Cancer Pembrolizumab is the new standard of care for patients with metastatic urothelial carcinoma previously treated with platinum chemotherapy Kidney Cancer Adjuvant tyrosine kinase inhibitor therapy for high risk disease is not effective and surgery only remains the standard of care
3 LATITUDE: A phase 3, double-blind, randomized trial of androgen deprivation therapy with abiraterone acetate plus prednisone or placebos <br />in newly diagnosed high-risk metastatic hormone-naïve prostate cancer patients Presented By Karim Fizazi at 2017 ASCO Annual Meeting
4 ADT + docetaxel: a new standard of care for men with mcnpc and high metastatic burden (2015) Presented By Karim Fizazi at 2017 ASCO Annual Meeting
5 Objective Presented By Karim Fizazi at 2017 ASCO Annual Meeting
6 Overall study design of LATITUDE Presented By Karim Fizazi at 2017 ASCO Annual Meeting
7 Statistically significant 38% risk reduction of death Presented By Karim Fizazi at 2017 ASCO Annual Meeting
8 Statistically significant 53% risk reduction of radiographic progression or death Presented By Karim Fizazi at 2017 ASCO Annual Meeting
9 Statistically significant 70% risk reduction of time to PSA progression Presented By Karim Fizazi at 2017 ASCO Annual Meeting
10 Statistically significant 30% risk reduction of time to pain progression Presented By Karim Fizazi at 2017 ASCO Annual Meeting
11 Statistically significant 58% risk reduction of time to subsequent <br />PC therapy Presented By Karim Fizazi at 2017 ASCO Annual Meeting
12 Slide 24 Presented By Karim Fizazi at 2017 ASCO Annual Meeting
13 Slide 1 Presented By Nicholas James at 2017 ASCO Annual Meeting
14 Abiraterone comparison: patients Presented By Nicholas James at 2017 ASCO Annual Meeting
15 Outcome measures Presented By Nicholas James at 2017 ASCO Annual Meeting
16 Patient characteristics Presented By Nicholas James at 2017 ASCO Annual Meeting
17 Slide 30 Presented By Nicholas James at 2017 ASCO Annual Meeting
18 Slide 38 Presented By Nicholas James at 2017 ASCO Annual Meeting
19 Slide 44 Presented By Nicholas James at 2017 ASCO Annual Meeting
20 Slide 53 Presented By Nicholas James at 2017 ASCO Annual Meeting
21 Slide 76 Presented By Nicholas James at 2017 ASCO Annual Meeting
22 Prostate Cancer Take Home Abiraterone acetate improves overall survival when added to androgen-deprivation therapy in high risk metastatic castration-sensitive prostate cancer and is the new standard of care Hazard ratio similar to that seen with docetaxel Given more favorable toxicity profile, abiraterone acetate is favored High-risk only or all patients with castration-sensitive metastatic disease?
23 FDA Approvals of Immune Checkpoint Inhibitors in Bladder Cancer Date Agent Approval Indication Line May 18, 2016 Atezolizumab Accelerated Platinum Pretreated 2nd Feb 2, 2017 Nivolumab Accelerated Platinum Pretreated 2nd April 17, 2017 Atezolizumab Accelerated Platinum Ineligible 1st May 1, 2017 Durvalumab Accelerated Platinum Pretreated 2nd May 9, 2017 Avelumab Accelerated Platinum Pretreated 2nd May 18, 2017 Pembrolizumab Full Platinum Pretreated 2nd May 18, 2017 Pembrolizumab Accelerated Platinum Ineligible 1st
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25 Updated Survival Analysis From KEYNOTE-045: Phase 3, Open-Label Study of Pembrolizumab Versus Paclitaxel, Docetaxel, or Vinflunine in Recurrent, Advanced Urothelial Cancer Presented By Dean Bajorin at 2017 ASCO Annual Meeting
26 KEYNOTE-045 Study Design (NCT ) Presented By Dean Bajorin at 2017 ASCO Annual Meeting
27 Overall Survival: Total Presented By Dean Bajorin at 2017 ASCO Annual Meeting
28 Progression-Free Survival: Total Presented By Dean Bajorin at 2017 ASCO Annual Meeting
29 Objective Response and Response Duration Presented By Dean Bajorin at 2017 ASCO Annual Meeting
30
31 Epacadostat Plus Pembrolizumab in Patients With Advanced Urothelial Carcinoma:<br />Preliminary Phase 1/2 Results of ECHO-202/KEYNOTE-037 Presented By David Smith at 2017 ASCO Annual Meeting
32 IDO1 Enzyme and Epacadostat Presented By David Smith at 2017 ASCO Annual Meeting
33 Patient Disposition<br />Epacadostat Plus Pembrolizumab<br />Phase 1/2 Advanced Urothelial Carcinoma Presented By David Smith at 2017 ASCO Annual Meeting
34 Best Objective Response by RECIST v1.1<br />Epacadostat Plus Pembrolizumab<br />Phase 1/2 Advanced Urothelial Carcinoma Presented By David Smith at 2017 ASCO Annual Meeting
35 Treatment-Related Adverse Events ( 5%)<br />Epacadostat Plus Pembrolizumab<br />Phase 1/2 Advanced Urothelial Carcinoma Presented By David Smith at 2017 ASCO Annual Meeting
36 Planned Phase 3 Trials of Pembrolizumab +/- Epacadostat KN672/ECHO-307 1st line - patients with previously untreated, cisplatin-ineligible, advanced/unresectable or metastatic urothelial carcinoma KN698/ECHO-303 2nd line - patients with locally advanced or metastatic urothelial carcinoma who have failed a first-line platinum-containing chemotherapy
37 Biomarker Findings and Mature Clinical Results From KEYNOTE-052: First-line Pembrolizumab in Cisplatin-ineligible Advanced Urothelial Cancer Presented By Peter O''Donnell at 2017 ASCO Annual Meeting
38 KEYNOTE-052 (NCT ): First-Line Pembrolizumab for Cisplatin-Ineligible Advanced Urothelial Cancer<br /> Presented By Peter O''Donnell at 2017 ASCO Annual Meeting
39 Baseline Characteristics Presented By Peter O''Donnell at 2017 ASCO Annual Meeting
40 Confirmed Objective Response Rate Presented By Peter O''Donnell at 2017 ASCO Annual Meeting
41 Bladder Cancer Take Home Pembrolizumab is the new standard of care for patients with metastatic urothelial carcinoma previously treated with platinum chemotherapy (based on Level 1 evidence) Atezolizumab or Pembrolizumab are first-line options for cisplatin-ineligible patients Lancet 2017 JCO 2011
42
43 Randomized phase III trial of adjuvant pazopanib versus placebo after nephrectomy in patients with locally advanced renal cell carcinoma (RCC) (PROTECT)<br /> Presented By Robert Motzer at 2017 ASCO Annual Meeting
44 Study Design Presented By Robert Motzer at 2017 ASCO Annual Meeting
45 Primary Analysis of DFS in ITT600mg Presented By Robert Motzer at 2017 ASCO Annual Meeting
46 Overall Survival in ITT600mg Presented By Robert Motzer at 2017 ASCO Annual Meeting
47 Secondary Analyses of DFS Presented By Robert Motzer at 2017 ASCO Annual Meeting
48 Kidney Cancer Take Home Adjuvant tyrosine kinase inhibitor therapy for high risk disease is not effective and surgery only remains the standard of care Patients with high risk renal cell cancer should be encouraged to participate in adjuvant clinical trials PROSPER KEYNOTE-564
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