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ESMO 2019: An Adaptive, Biomarker-Directed Platform Study with Durvalumab in Combination with Targeted Therapies in Metastatic Urothelial Cancer (BISCAY)

Barcelona, Spain (UroToday.com) BISCAY was a novel biomarker-directed platform for testing multiple immune-oncology combinations in metastatic urothelial carcinoma (mUC). Specifically, BISCAY sought to evaluate an anti-PD-L1 backbone in combination with any of three specific biomarker-directed targeted therapies: FGFR inhibition with AZD4547, TORC1/2 inhibition with vistusertib, and PARP inhibition with olaparib. Patients were assigned to treatment […]

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ESMO 2019: An Adaptive, Biomarker Directed Platform Study in Metastatic Urothelial Cancer (BISCAY) with Durvalumab in Combination with Targeted Therapies

Barcelona, Spain (UroToday.com) Platinum-based chemotherapy is the standard of care in patients with locally advanced or metastatic urothelial carcinoma, but this therapy is often toxic with overall response rates of 50% or less. The PD-L1 inhibitor Durvalumab was approved by the United States FDA in May 2017 for post-platinum disease based on a phase 1/2 […]

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ESMO 2019: TROPHY-U-01: Initial Results of a Phase 2 Open-Label Study of Sacituzumab Givotecan in Patients with Metastatic Urothelial Cancer after Failure of Platinum-Based Regimens or Immunotherapy

Barcelona, Spain (UroToday.com) Human trophoblast cell surface antigen 2 (Trop-2) is a transmembrane glycoprotein which is highly expressed in urothelial carcinoma cells, thereby constituting a promising target for antibody-drug conjugate therapy.1 Sacituzumab govitecan is an antibody-drug conjugate comprised of the Trop-2 humanized monoclonal antibody sacituzumab coupled to SN-38, the active metabolite of irinotecan via a […]

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ESMO 2019: Invited Discussant – Redefining the International Germ Cell Cancer Collaborative Group Classification in Advanced Non-Seminoma

Barcelona, Spain (UroToday.com) As discussant for the updated prognostic model for germ cell tumors presented by Dr. Silke Gillessen and colleagues, Dr. Jan Oldenburg posed the question of whether this work is relevant. He promptly answered this question as yes. The 1997 International Germ Cell Cancer Collaborative Group (IGCCCG) prognostic model, which divided patients into […]

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ESMO 2019: The International Germ Cell Cancer Collaborative Group Classification in Advanced Non-Seminoma – Redefined

Barcelona, Spain (UroToday.com) The International Germ Cell Cancer Collaborative Group (IGCCCG) has been the reference classification for assessing prognosis in men with advanced non-seminomatous germ-cell tumors (NSGCT) for more than 20 years. This initial model relied on 5,202 cases treated between 1975 and 1990. However, whether this classification system is still relevant has not been […]

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ESMO 2019: Redefining the International Germ Cell Cancer Collaborative Group Classification in Advanced Non-Seminoma

Barcelona, Spain (UroToday.com) Since its publication in 1997, the International Germ Cell Cancer Collaborative Group (IGCCCG) classification has stratified patients with disseminated germ cell tumors into good, intermediate or poor risk groups based on histology, tumor location, and serum tumor markers. This classification system was established using clinical data from just over 5000 non-seminomas and 600 […]

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Seattle Genetics and Astellas Announce Results from Phase 1 Trial of Investigational Agent Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Bladder Cancer

San Francisco, CA (UroToday.com) — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. announced initial results from the phase 1 clinical trial EV-103. Forty-five patients were evaluated for safety with the combination of the investigational agent enfortumab vedotin and the immune therapy pembrolizumab in previously untreated patients […]

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ESMO 2019: Tailored ImmunoTherapy Approach with Nivolumab in Advanced Renal Cell Carcinoma

Barcelona, Spain (UroToday.com) Nivolumab + ipilimumab has been approved for the 1st line treatment of IMDC intermediate and poor-risk advanced RCC based on results from the CheckMate-214 trial1. However, administration of nivolumab + ipilimumab in a fixed regimen with 4 induction cycles may result in more treatment-related adverse events compared with nivolumab alone. In previous studies, […]

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ESMO 2019: Primary Efficacy Analysis Results from the SORCE Trial: Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse

Barcelona, Spain (UroToday.com) There has been much interest in improving disease free survival (DFS) and overall survival (OS) among patients with locally advanced kidney cancer undergoing radical nephrectomy. As such, several adjuvant therapy trials for high risk patients have been reported over the last few years. However, unfortunately no trial to date has demonstrated an […]

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ESMO 2019: Invited Discussant: How to Combine Immunotherapy in Urothelial Cancer?

Barcelona, Spain (UroToday.com) Yohann Loriot, MD, MSc, provided a discussion of two trials in metastatic urothelial cancer, EV-103, and BISCAY, at the ESMO 2019 annual congress. Dr. Loriot notes that the current and future strategies of immunotherapy include (i) targeting multiple checkpoint pathways, (ii) increasing the neo-antigen expression, (iii) combining with chemotherapy, radiotherapy, and targeted therapies, […]

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