ASCO GU 2018: Avelumab as Neoadjuvant Therapy in Subjects with Muscle-invasive Urothelial Carcinoma - AURA Trial

San Francisco, CA ( Dr. Nieves Martinez Chanza from Belgium provided an overview of the AURA trial, assessing avelumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC). Avelumab is a fully human anti-PD-L1 IgG1 monoclonal antibody, approved in monotherapy for the advanced disease [1]. For patients with non-metastatic MIBC the current preferred treatment consists of a multimodal approach comprising neoadjuvant cisplatin-based chemotherapy followed by surgery. However, the benefit of the neoadjuvant chemotherapy is modest and an important proportion of patients do not benefit providing unnecessary toxicity and potential morbidity. Additionally, 40% of this population is ineligible for platinum-based therapies and currently no medical alternative option exists. The objective of this study was to assess several important questions:

ASCO GU 2018: Immune Checkpoint Inhibitors: Which One and Why?

San Francisco, CA ( Dr. Powles provided the first of two Keynote Lectures in Urothelial Carcinoma (UC). As the landscape in advanced bladder cancer has been rapidly changing with the introduction of immune checkpoint inhibitors (ICI), he provided an overview of ICI’s in UC at the current time and his input on which one to use.

ASCO GU 2018: Two-year Follow-up: 3 KEYNOTE-045 Trial of Pembrolizumab vs Investigator’s Choice Chemotherapy in Recurrent, Advanced Urothelial Cancer

San Francisco, CA ( Based on interim results from the phase 3 KEYNOTE-045 study comparing pembrolizumab (pembro) vs. investigator’s choice (paclitaxel, docetaxel, or vinflunine) or chemotherapy (chemo), pembro was approved for the treatment of locally advanced or metastatic UC that has progressed during or after a platinum-containing regimen. The authors presented updated results after 2 years of follow-up.

ASCO GU 2018: New 6-factor prognostic model for patients with advanced urothelial carcinoma receiving post-platinum atezolizumab

San Francisco, CA ( The introduction of checkpoint inhibitors as a second line agent has been a game changer in the treatment of urothelial carcinoma patients. Following landmark results of the Keynote-045, the FDA has now approved of four other PD-1 and PD-L1 inhibitors. While some of these checkpoint inhibitors have validated the results of Keynote-045, some others have shown contradictory results (IMvigor210) leading some experts to wonder if the differences are patient related. A team of investigators involved with IMvigor210 have decided to use the available data from the trial to identify key predictive characteristics that may impact response and ultimately overall survival (0S) in UC patients who have failed platinum chemotherapy.  

ASCO GU 2018: Atezolizumab vs. Chemotherapy in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma - Outcomes from the Phase III IMvigor211 Study

San Francisco, CA ( IMvigor211 is a global study of atezolizumab vs chemotherapy in platinum-treated metastatic urothelial carcinoma (Muc). The study did not meet its primary endpoint of overall survival (OS) in programmed death-ligand 1 (PD-L1)–selected patients (pts),1 but exploratory analyses showed improved OS for atezo in the intent-to-treat (ITT) population. In this study the authors compared clinical outcomes in ITT and pre-specified PD-L1 subgroups with those in subgroups defined by immune transcriptional gene expression (tGE) signatures and tumor mutational burden (TMB).

ASCO GU 2018: Nivolumab Monotherapy in Metastatic Urothelial Carcinoma: Longer-term Efficacy and safety Results from the CheckMate 032 Study

San Francisco, CA ( Few options exist for patients who fail front-line platinum-based chemotherapy for metastatic urothelial carcinoma (UC). With the advent of immunomodulatory (IO) agents, this era is finally coming to an end. An important study in this space is the ongoing CheckMate 032 trial. This 3-arm trial is a nonrandomized study of treating platinum-resistant metastatic UC with: 1. Nivolumab-only; 2. Nivolumab + ipilimumab (1mg/kg); 3. Nivolumab + ipilimumab (3mg/kg).

ASCO GU 2018: A Genomic Classifier for Identifying a Neuroendocrine-like Bladder Cancer Subtype

San Francisco, CA (  Neuroendocrine (NE) carcinoma is a rare and aggressive variant of muscle invasive bladder cancer (MIBC). As previous abstracts at this conference have demonstrated, survival in patients with non-urothelial bladder cancer is uniformly worse than urothelial bladder cancer (Jeanny Aragon-Ching, Abstract 425, GU ASCO 2018).

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