Optimizing treatment for metastatic bladder cancer in chemotherapy-resistant urothelial carcinoma. Moran Gadot M.D SHEBA Medical Center ISRAEL
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1 Optimizing treatment for metastatic bladder cancer in chemotherapy-resistant urothelial carcinoma Moran Gadot M.D SHEBA Medical Center ISRAEL
2 Disclosures none
3 All (eligible) patients should get chemotherapy for 1 st line Treatment
4 Who is chemotherapy resistant? Patient who developed disease progression During chemotherapy Tx Within 12 month from completing neo-adjuvant chemotherapy Within 12 month from completing firs line chemotherapy (Cis ineligible= chemotherapy resistant?)
5 Subsequent systemic treatment- Post Platinum
6 Considerations for subsequent therapy ECOG Previous treatment and response to treatment Clinical trial Local treatment Genomics? Biomarkers? Health and Drug Basket
7 Subsequent treatment Immunotherapy chemotherapy Targeted therapy Pembrolizumab Nab-paclitaxel Paclitaxel Ramucirumab (+Docetaxel) Atezolizumab Docetaxel Gemcitabine Erdafitinib (FGFRi) Nivolumab Pemetrexed Vinflunine (Europe) Enfortumab Vedotin (nectin 4 i) Durvalumab Ifosfamid MTX Avelumab Oxaliplatin CT dublet DDMVAC
8 Immunotherapy
9 Presented By Thomas Powles at 2018 ASCO Annual Meeting Changes to PD-L1 and CD8 expression with therapy
10 chemotherapy FGFR CDK Immunotherapy RR chemotherapy
11 2 nd line CT after failure of platinum salt: single-agent ph II trials Author & year of publ. Agent N (evaluable) ORR (%) PFS (mo) OS (mo) Pronzato, NR 0.8 Ifosfamide Witte, Mc Caffrey, NR 9.0 Docetaxel Choueiri, 2012 (1 arm out of 2) 75 (72) Papamichael, NR NR Vaughn, 2002 Paclitaxel Joly, (37) Lorusso, (31) Gemcitabine Albers, (28) Witte, 1998 Topotecan Dodd, 2000 Pyrazoloacridine 14 0 NR 9.0 Roth, 2002 Piritrexim 35 (27) Moore, 2003 Oxaliplatin 18 6 NR NR Dreicer, 2007 Epothilone B 45 (42) Sweeney, 2006 Galsky, 2007 Crevera-Grau, ASCO 2012 Pemetrexed NR 2.9 NR NR 7.2 Sridhar, ASCO GU 2011 Nab-paclitaxel J Lee, ASCO GU 2011 Paclitaxel PM Loriot, ASCO 2012 Pralatrexate (conf.) No compound tested in phase III, no further development
12 Targeted therapy
13 RANGE trial- Docetaxel +/- Ramucirumab Phase III post platinum N-530 pep PFS 4.1 vs 2.8 months HR 0.76 ORR 24.5 vs 14% trend for OS benefit Powles et al. Lancet. 2017;390(10109):2266
14 Erdafitinib- FGFRi First Results From the Primary Analysis Population <br />of the Phase 2 Study of Erdafitinib <br />(JNJ ) in Patients With Metastatic or Surgically Unresectable Urothelial Carcinoma and FGFR Alterations Presented By Arlene Siefker-Radtke at 2018 ASCO Annual Meeting
15
16 The FGFR Landscape in Cancer: Analysis of 4,853 Tumors by Next-Generation Sequencing T Helsten et al.ccr January 2016
17 FGFR Alterations Are Common in Cancer Presented By Arlene Siefker-Radtke at 2018 ASCO Annual Meeting
18
19
20
21 Response to Erdafitinib in a Patient With Liver Metastases Presented By Arlene Siefker-Radtke at 2018 ASCO Annual Meeting
22 Responses <br />to Erdafitinib <br />Were Maintained Presented By Arlene Siefker-Radtke at 2018 ASCO Annual Meeting
23 The SHEBA Medical Center experience Based on two early phase clinical trials with two investigational products: n=12 Best response- two drugs combined * FGFR Inhibitor INCB ( INCB ) * Pan FGFR kinase inhibitor BGJ398 ( Novartis ) 30% 10% 20% 20% Median time on drug 1.6 month (range 5 days to 13.3 months) 20% PR clinical PR SD mixed PD
24 Presented By Andrea Necchi at 2018 ASCO Annual Meeting
25 Enfortumab Vedotin- anti nectin 4 Updated Results From the Enfortumab Vedotin Phase 1 (EV-101) Study in Patients With Metastatic Urothelial Cancer Presented By Jonathan Rosenberg at 2018 ASCO Annual Meeting
26 Enfortumab Vedotin is an Antibody Drug Conjugate (ADC) that Targets Nectin-4 Presented By Evan Yu at 2018 ASCO Annual Meeting
27 Enfortumab Vedotin Phase 1 Updated Efficacy Results Presented By Evan Yu at 2018 ASCO Annual Meeting
28 Enfortumab Vedotin Phase 1 Safety Results Presented By Evan Yu at 2018 ASCO Annual Meeting
29 Duration of Response Presented By Jonathan Rosenberg at 2018 ASCO Annual Meeting
30 HER2/neu, an Oldie but Goodie Presented By Evan Yu at 2018 ASCO Annual Meeting
31 DNA Repair Genes and Homologous Recombination Deficiency Presented By Evan Yu at 2018 ASCO Annual Meeting
32 Ongoing clinical trials Immunotherapy doublet Targeted therapies Combinations: Immunotherapy-chemotherapy Immunotherapy-targeted therapy
33 conclusion We can maximize treatment after chemotherapy failure! Genomics- Molecular stratification of treatment Clinical trials! Thank you!
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