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San Francisco, California (UroToday.com) -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO® (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in early 2021.

Anti-programmed cell death ligand 1 (PD-L1)/programmed cell death 1 antibodies have shown clinical activity in platinum-treated metastatic urothelial carcinoma, resulting in regulatory approval of several agents, including avelumab (anti-PD-L1).

BACKGROUND Platinum-based chemotherapy is standard-of-care first-line treatment for advanced urothelial carcinoma. However, progression-free survival and overall survival are limited by chemotherapy resistance.
Conference Coverage
Conference Highlights from Recent Conference Coverage
Presented by Neal Shore, MD, FACS, and Robert Dreicer, MD
At the 2020 Society of Urologic Oncology (SUO) Annual Virtual Meeting, Dr. Neal Shore chaired a session examining the use of newer and emerging agents in bladder cancer, which highlighted a presentation by medical oncologist Dr. Robert Dreicer discussing novel treatment options for patients with advanced bladder cancer.
Presented by Matthew Galsky, MD
In an oral presentation in the Refining the Treatment of Bladder Cancer session at the 12th European Multidisciplinary Congress on Urological Cancers (EMUC), Dr. Matthew Glasky presented an overview of optimal first-line approaches to the treatment of metastatic bladder cancer. Dr. Galsky began by highlighting the treatment approach in what he called the “not too distant past:
Presented by  Petros Grivas, MD, PhD
The multidisciplinary team approach to the treatment of urothelial carcinoma in the age of anti-PD1 agents instructional course was chaired by Dr. Shaheen Alanee and included Dr. Petros Grivas who provided a lecture on the benefits of a multidisciplinary team approach for patients receiving treatment with anti PD agents,
Presented by Prof. Dr. Jürgen Gschwend, PhD
Dr. Juergen Gschwend summarized the three important abstracts in the setting of metastatic urothelial carcinoma (mUC) that were presented at the European Society of Medical Oncology (ESMO) 2020 Virtual Congress: TROPHY-U-01 Cohort 1 Final Results, Patient-reported outcomes (PROs) from IMvigor130, and Avelumab first-line maintenance + best supportive care (BSC) vs. BSC alone for advanced UC. 
Presented by Killan M. Gust, MD, FEBU
 Dr. Kilian Gust began his discussion of three abstracts in unresectable, metastatic urothelial carcinoma, and advanced urothelial carcinoma with a discussion on historical efficacy rates of platinum therapy as first-line treatment for advanced urothelial carcinoma.
Presented by Srikala Sridhar, MD
Responses to immune checkpoint blockade in cancer therapy are heterogeneous, with a minority of patients experiencing sustained responses to therapy. The identification of predictive biomarkers for immunotherapy response is an area of intense research interest. 
Presented by Thomas B. Powles, MBBS, MRCP, MD
Urothelial carcinoma has a substantial impact on patient qualify of life. Patients may experience a multitude of disease-related symptoms, including pain, urinary frequency, physical changes, and mental health issues, with all affect quality of life. 
Presented by Kilian M. Gust, MD, FEBU
At this year’s European Society of Medical Oncology (ESMO) 2020 Virtual Congress, following a number of abstracts assessing the role of immunotherapy in advanced urothelial carcinoma, Dr. Kilian Gust provided an invited discussion regarding the future of immunotherapy in this disease with a focus on how to combine and sequence therapies. 
Presented by Petros Grivas, MD, Ph.D.
Advanced urothelial carcinoma has among the worst prognosis for tumors treated by genitourinary oncologists. Standard of care dictates that patients receive platinum-based induction chemotherapy.
Presented by Elizabeth Plimack, MD
In this presentation, Elizabeth Plimack, MD, discussed the findings from LBA1, a phase 3 randomized study of maintenance avelumab in advanced urothelial cancer patients who have not progressed with first-line platinum-based chemotherapy. First, Dr. Plimack described the landscape of therapies for metastatic urothelial cancers.
Presented by Thomas Powles, MBBS, MRCP, MD
Advanced urothelial carcinoma resulted in over 200,000 deaths across the world in 2018. Though the majority of patients eligible for such therapy respond to platinum-based chemotherapy, disease progression occurs relatively quickly and half or less of patients receive second line treatment.
Presented by Cora Sternberg MD, FACP
Dr. Cora Sternberg gave an overview of the new standards of first-line therapy in advanced urothelial bladder carcinoma. There has been almost no progress at all during the last 30 years in the management of advanced urothelial carcinoma. However, in the last 5 years, five new immunotherapeutic agents have been introduced for the treatment of advanced urothelial carcinoma,