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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
Videos
JAVELIN Bladder 100 Trial Discussion Videos
Publications
Articles and Abstracts
Avelumab first-line maintenance in locally advanced or metastatic urothelial carcinoma: Applying clinical trial findings to clinical practice.
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.
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Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma
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.
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Avelumab as second-line therapy for metastatic, platinum-treated urothelial carcinoma in the phase Ib JAVELIN Solid Tumor study: 2-year updated efficacy and safety analysis.
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).
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Conference Coverage
Conference Highlights Written by Physician-Scientist
ASCO GU 2022: Avelumab First-Line Maintenance + Best Supportive Care Versus BSC Alone in Asian Patients With Advanced Urothelial Carcinoma: JAVELIN Bladder 100 Subgroup Analysis
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). Read More
ASCO GU 2022: First Line Avelumab in PD-L1+ve Metastatic or Locally Advanced Urothelial Cancer Patients Unfit for Cisplatin: The ARIES Trial
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. Read More
ANZUP Mini ASM 2021: Evolving Treatment Landscape for Metastatic Urothelial Cancer
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. Read More
AUA 2021: Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Analysis of Clinical and Genomic Subgroups From the JAVELIN Bladder 100 Trial
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. Read More
AUA 2021: Avelumab First-Line Maintenance Plus Best Supportive Care vs Best Supportive Care Alone for Advanced Urothelial Carcinoma: Analysis of Time to End of Next-Line Therapy in JAVELIN Bladder 100
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). Read More
ASCO 2021: Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma in the JAVELIN Bladder 100 Trial: Subgroup Analysis by Duration of Treatment-Free Interval from End of Chemotherapy to Start of Maintenance
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). Read More
ASCO 2021: Avelumab First-Line Maintenance plus Best Supportive Care Versus Best Supportive Care Alone for Advanced Urothelial Carcinoma: Analysis of Time to End of Next-Line Therapy in JAVELIN Bladder 100
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. Read More
ASCO 2021: Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Analysis of Clinical and Genomic Subgroups from the 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). Read More
SES AUA 2021: Avelumab First-Line Maintenance + Best Supportive Care (BSC) vs BSC Alone with 1L Chemotherapy for Advanced Urothelial Carcinoma: JAVELIN Bladder 100 Subgroup Analyses
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. Read More
ASCO GU 2021: Avelumab First-Line Maintenance Plus Best Supportive Care vs Best Supportive Care Alone For Advanced Urothelial Carcinoma: JAVELIN Bladder 100 Subgroup Analysis Based On Duration And Cycles Of First-Line Chemotherapy
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. Read More
ASCO GU 2021: Avelumab First-Line Maintenance plus Best Supportive Care (BSC) Versus BSC Alone for Advanced Urothelial Carcinoma: JAVELIN Bladder 100 Japanese Subgroup Analysis
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. Read More
SUO 2020: Navigating Novelty in Advanced Disease: Current Evidence and Adaptive Strategies for Sequencing Immune Checkpoint Inhibitors, FGFR Inhibitors, and Antibody-Drug Conjugates
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. Read More
EMUC 2020: Optimal First Line Therapy in Metastatic Bladder Cancer Disease
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: Read More
SIU Virtual Congress 2020: Benefits of MDT Approach for Patients Receiving Treatment with Anti PD Agents, and the Role of Anti-PD1 Agents in the Management of Locally Advanced and Metastatic Bladder Cancer
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, Read More
ESMO Virtual Congress 2020: The Landscape is Moving in Metastatic Urothelial Carcinoma - Invited Discussant
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. Read More
ESMO Virtual Congress 2020: Unresectable or Metastatic Urothelial Carcinoma and Advanced Urothelial Carcinoma - Invited Discussant
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. Read More
ESMO 2020 Virtual Congress: Avelumab First-Line Maintenance + Best Supportive Care vs. BSC Alone with 1L Chemotherapy for Advanced Urothelial Carcinoma: Subgroup Analyses from JAVELIN Bladder 100
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. Read More
ESMO Virtual Congress 2020: Avelumab First Line Maintenance + Best Supportive Care vs BSC Alone for Advanced Urothelial Carcinoma: Association between Clinical Outcomes and Exploratory Biomarkers
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. Read More
ESMO Virtual Congress 2020: Invited Discussant Bladder Cancer (PROs from IMvigor130, Biomarker Exploratory Analyses for Correlates of Overall Survival in JAVELIN Bladder 100, and Updated Cohort 1 Data for Sacituzumab Govitecan in mUC
Presented by Juergen Gschwend, MD
In this discussion, Juergen Gschwend, MD, discussed (patient-reported outcomes from IMvigor130), (biomarker exploratory analyses for correlates of overall survival in JAVELIN Bladder 100), and LB24 (updated cohort 1 data for sacituzumab govitecan in heavily pre-treated metastatic urothelial carcinoma). Read More
ESMO Virtual Congress 2020: Patient-Reported Outcomes from JAVELIN Bladder 100: Avelumab First-Line Maintenance Plus Best Supportive Care vs Best Supportive Care Alone For Advanced Urothelial Carcinoma
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. Read More
ESMO Virtual Congress 2020: What is the Future of Immunotherapy in Urothelial Cancer?
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. Read More
ESMO Virtual Congress 2020: Subgroup Analyses from JAVELIN Bladder 100: Avelumab first-line (1L) maintenance + Best Supportive Care (BSC) vs BSC Alone with 1L Chemotherapy for Advanced Urothelial Carcinoma
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. Read More
ASCO 2020: Checkpoint Inhibition in Metastatic Urothelial Carcinoma: Timing is Everything
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. Read More
ASCO 2020: JAVELIN Bladder 100 Phase III Results: Maintenance Avelumab + Best Supportive Care vs BSC Alone After Platinum-Based First-Line Chemotherapy in Advanced Urothelial Carcinoma
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. Read More
ASCO GU 2020: New Standards in First-Line Therapy for Advanced Disease
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, Read More