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JAVELIN Bladder 100 Trial - Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
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JAVELIN Bladder 100 Trial Discussion Videos

Publications
Articles and Abstracts

Although urothelial carcinoma (UC) is considered a chemotherapy-sensitive tumor, progression-free survival and overall survival (OS) are typically short following standard first-line (1L) platinum-containing chemotherapy in patients with locally advanced or metastatic disease.

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.

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).

Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Thomas B. Powles, MBBS, MRCP, MD
The 2022 European Society of Medical Oncology (ESMO) annual meeting featured a urothelial carcinoma session, including a presentation by Dr. Tom Powles discussing genomic biomarkers in peripheral blood from patients enrolled in the JAVELIN Bladder 100 trial of avelumab first-line maintenance in advanced urothelial carcinoma.
Presented by Masatoshi Eto MD, PhD
Dr. Eto presented results of a subgroup analysis of Asian patients enrolled on JAVELIN Bladder 100, investigation avelumab maintenance in patients with advanced urothelial carcinoma (UC). 
Presented by Roberto Iacovelli, PhD, MD
Dr. Iacovelli and colleagues who examined first-line avelumab in patients with PD-L1+ve metastatic or locally advanced urothelial cancer (aUC) who are unfit for cisplatin. Avelumab IS approved as maintenance therapy after platinum-based first-line (1L) therapy for patients with aUC based on data from the phase III JAVELIN Bladder 100 trial.
Presented by Matthew Galsky, MD
 The ANZUP 2021 annual scientific meeting included a presentation by Dr. Matthew Galsky discussing the evolving treatment landscape for metastatic urothelial cancer. Dr. Galsky started by highlighting that urothelial carcinoma is not an uncommon malignancy, accounting for 82,000 new diagnoses/year in the United States and ~429,000 new diagnoses/year worldwide. However, until recently, the FDA approvals for new therapeutics in urothelial cancer over the last 30 years has been dismal.
Presented by Joaquim Bellmunt, MD, PhD
As a follow-up to the JAVELIN BLADDER 100 trial,1 which demonstrated the efficacy of avelumab as first-line maintenance therapy for patients with advanced urothelial carcinoma who have NOT progressed on first-line platinum-based chemotherapy, Dr. Bellmunt and colleagues herein report post hoc analyses in previously unreported clinical and genomic subgroups.
As a follow-up to the JAVELIN BLADDER 100 trial,1 which demonstrated the efficacy of avelumab as a first line maintenance therapy for patients with advanced urothelial carcinoma who have NOT progressed on first line platinum based chemotherapy, Dr. Bellmunt and colleagues herein report a secondary analysis of time to end of next-line therapy in patients treated with avelumab vs. best supportive care (BSC).
Presented by Srikala Sridhar MD, MSc, FRCPC
The phase 3 JAVELIN Bladder 100 trial, which enrolled patients with advanced urothelial carcinoma that had not progressed with first-line platinum-containing chemotherapy, showed that maintenance therapy with avelumab + best supportive care significantly prolonged overall survival (OS) compared with best supportive care alone (HR 0.69, 95% CI 0.56 to 0.86; 1-sided p = 0.0005).
Presented by Petros Grivas, MD, Ph.D
Avelumab first-line maintenance is approved in various countries for patients with advanced urothelial carcinoma that has not progressed with first-line platinum-based chemotherapy based on significantly prolonged overall survival (OS) seen with avelumab + best supportive care versus best supportive care alone in the phase 3 JAVELIN Bladder 100 trial.
Presented by Thomas Powles, MBBS, MRCP, MD,
In the phase 3 JAVELIN Bladder 100 trial, avelumab first-line maintenance + best supportive care significantly prolonged overall survival versus best supportive care alone in patients with advanced urothelial carcinoma that had not progressed on first-line platinum-based chemotherapy (HR 0.69, 95% CI 0.56 to 0.86; 1-sided p = 0.0005).
Presented by Petros Grivas, MD, PhD
In Best of Podium presentation at this year’s Southeast Section of the American Urologic Association Virtual Annual Meeting, Dr. Grivas presented pre-specified subgroup analyses of the JAVELIN Bladder 100 trial.
Presented by Yohann Loriot, MD, PhD
Avelumab first-line maintenance therapy is approved in the United States for patients with advanced urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy based on significantly prolonged overall survival versus best supportive care alone (median 21.4 months versus 14.3 months; HR 0.69, 95% CI 0.56-0.86) as reported in the phase III JAVELIN Bladder 100 trial.
Presented by Norihiko Tsuchiya, MD
 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 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 Petros Grivas, MD, PhD
The JAVELIN Bladder 100 trial, previously presented at ASCO 2020, was a phase 3 trial of platinum-eligible patients with advanced urothelial carcinoma who had stable disease after standard first line chemotherapy and then were randomized to avelumab maintenance therapy versus best supportive care. This trial demonstrated a significantly longer overall survival in patients who received standard platinum-based chemotherapy for advanced urothelial carcinoma followed by avelumab maintenance therapy.
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 Juergen Gschwend, MD
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,
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