Avelumab first-line maintenance treatment for advanced urothelial carcinoma: review of evidence to guide clinical practice

Cancer statistics, 2023

(2023) Rebecca L. Siegel et al.   CA-A CANCER JOURNAL FOR CLINICIANS

Response and outcomes of maintenance avelumab after platinum-based chemotherapy (PBC) in patients with advanced urothelial carcinoma (aUC): ‘real world’ experience

(2023) Dimitra Rafailia Bakaloudi et al.   Clinical Genitourinary Cancer

Baseline characteristics from a retrospective, observational, US-based, multicenter, real-world (RW) study of avelumab first-line maintenance (1LM) in locally advanced/metastatic urothelial carcinoma (la/mUC) (PATRIOT-II).

(2023) Petros Grivas et al.   JOURNAL OF CLINICAL ONCOLOGY

TROPHY-U-01 cohort 6: Sacituzumab govitecan (SG), SG plus zimberelimab (ZIM), SG plus ZIM plus domvanalimab (DOM), or carboplatin (CARBO) + gemcitabine (GEM) in cisplatin-ineligible patients (pts) with treatment-naive metastatic urothelial cancer (mUC).

(2023) Ignacio Duran et al.   JOURNAL OF CLINICAL ONCOLOGY

Estimated net benefit of avelumab (AVE) + best supportive care (BSC) vs BSC alone for patients (pts) with advanced urothelial carcinoma (aUC) using a quality-adjusted time without cancer symptoms or toxicity (Q-TWiST) analysis.

(2023) Thomas Powles et al.   JOURNAL OF CLINICAL ONCOLOGY

READY: Real-world data from an Italian compassionate use program of avelumab first-line maintenance (1LM) treatment for locally advanced or metastatic urothelial carcinoma (la/mUC).

(2023) Lorenzo Antonuzzo et al.   JOURNAL OF CLINICAL ONCOLOGY

Response and outcomes of maintenance avelumab after platinum-based chemotherapy (PBC) in patients (pts) with advanced urothelial carcinoma (aUC): "Real world" experience.

(2023) Dimitra Rafailia Bakaloudi et al.   JOURNAL OF CLINICAL ONCOLOGY

Long-term safety of avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC) in the JAVELIN Bladder 100 trial.

(2023) Joaquim Bellmunt et al.   JOURNAL OF CLINICAL ONCOLOGY

Final overall survival (OS) analysis of atezolizumab (atezo) monotherapy vs chemotherapy (chemo) in untreated locally advanced or metastatic urothelial carcinoma (mUC) from the Phase 3 IMvigor130 study.

(2023) Aristotelis Bamias et al.   JOURNAL OF CLINICAL ONCOLOGY

Atezolizumab (atezo) + platinum/gemcitabine (plt/gem) vs placebo + plt/gem for first-line (1L) treatment (tx) of locally advanced or metastatic urothelial carcinoma (mUC): Final OS from the randomized Phase 3 IMvigor130 study.

(2023) Matt D. Galsky et al.   JOURNAL OF CLINICAL ONCOLOGY

Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After ≥2 Years of Follow-Up

(2023) Thomas Powles et al.   JOURNAL OF CLINICAL ONCOLOGY

Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up from the JAVELIN Bladder 100 trial in subgroups defined by 1L chemotherapy regimen and analysis of overall survival (OS) from start of 1L chemotherapy.

(2023) Srikala S. Sridhar et al.   JOURNAL OF CLINICAL ONCOLOGY

Full analysis from AVENANCE: A real-world study of avelumab first-line (1L) maintenance treatment in patients (pts) with advanced urothelial carcinoma (aUC).

(2023) Philippe Barthelemy et al.   JOURNAL OF CLINICAL ONCOLOGY

Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial

(2023) Petros Grivas et al.   EUROPEAN UROLOGY

Disease management and frontline treatment of locally advanced or metastatic urothelial (la/mUC) carcinoma: The U.S. physician PARADIGM study.

(2022) Shilpa Gupta et al.   JOURNAL OF CLINICAL ONCOLOGY

First-line pembrolizumab (pembro) with or without lenvatinib (lenva) in patients with advanced urothelial carcinoma (LEAP-011): A phase 3, randomized, double-blind study.

(2022) Yohann Loriot et al.   JOURNAL OF CLINICAL ONCOLOGY

Criteria used to determine platinum eligibility and first-line (1L) treatment (tx) patterns among platinum-eligible (PE) and -ineligible (PI) patients (pts) with metastatic urothelial cancer (mUC) in France, Germany, Spain, Italy, and the United Kingdom (Eu5).

(2022) Neil Milloy et al.   JOURNAL OF CLINICAL ONCOLOGY

Study EV-302: A two-arm, open-label, randomized controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy in previously untreated advanced urothelial carcinoma (aUC) (trial in progress).

(2022) Michiel Simon Van Der Heijden et al.   JOURNAL OF CLINICAL ONCOLOGY

Patient-reported Outcomes from JAVELIN Bladder 100: Avelumab First-line Maintenance Plus Best Supportive Care Versus Best Supportive Care Alone for Advanced Urothelial Carcinoma

(2022) Petros Grivas et al.   EUROPEAN UROLOGY

Plain language summary of results from the JAVELIN Bladder 100 study: avelumab maintenance treatment for advanced urothelial cancer

(2022) Thomas Powles et al.   Future Oncology

Reassessment of the Efficacy of Carboplatin for Metastatic Urothelial Carcinoma in the Era of Immunotherapy: A Systematic Review and Meta-analysis

(2022) Keiichiro Mori et al.   European Urology Focus

MAIN-CAV: Phase III randomized trial of maintenance cabozantinib and avelumab versus avelumab after first-line platinum-based chemotherapy in patients with metastatic urothelial cancer (mUC) (Alliance A032001).

(2022) Shilpa Gupta et al.   JOURNAL OF CLINICAL ONCOLOGY

Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC).

(2022) Shilpa Gupta et al.   JOURNAL OF CLINICAL ONCOLOGY

Long-term outcomes in patients with advanced urothelial carcinoma (UC) who received avelumab first-line (1L) maintenance with or without second-line (2L) treatment: Exploratory analyses from JAVELIN Bladder 100.

(2022) Joaquim Bellmunt et al.   JOURNAL OF CLINICAL ONCOLOGY

Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from JAVELIN Bladder 100 in subgroups defined by response to 1L chemotherapy.

(2022) Begoña Pérez-Valderrama et al.   JOURNAL OF CLINICAL ONCOLOGY

1760P Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Results from patients with ≥12 mo of treatment in JAVELIN Bladder 100

(2022) J.B. Aragon-Ching et al.   ANNALS OF ONCOLOGY

LBA74 Genomic biomarkers in peripheral blood (PB) from patients (pts) enrolled in the JAVELIN Bladder 100 trial of avelumab first-line (1L) maintenance in advanced urothelial carcinoma (aUC)

(2022) T.B. Powles et al.   ANNALS OF ONCOLOGY

LBA73 Study EV-103 Cohort K: Antitumor activity of enfortumab vedotin (EV) monotherapy or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients (pts) with locally advanced or metastatic urothelial cancer (la/mUC)

(2022) J.E. Rosenberg et al.   ANNALS OF ONCOLOGY

1750P Factors associated with the receipt of systemic treatment (tx) for metastatic urothelial carcinoma (mUC) in England

(2022) C. Knott et al.   ANNALS OF ONCOLOGY

Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer

(2022) Christopher J. Hoimes et al.   JOURNAL OF CLINICAL ONCOLOGY

Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries

(2021) Hyuna Sung et al.   CA-A CANCER JOURNAL FOR CLINICIANS

Avelumab (Ave) first-line (1L) maintenance plus best supportive care (BSC) versus BSC alone for advanced urothelial carcinoma (UC): JAVELIN Bladder 100 subgroup analysis based on duration and cycles of 1L chemotherapy.

(2021) Yohann Loriot et al.   JOURNAL OF CLINICAL ONCOLOGY

707P Treatment pattern and overall survival among patients with locally advanced or metastatic urothelial carcinoma: Results from a complete nationwide unselected real-world registry study in Denmark from 2010 to 2017

(2021) J.B. Jensen et al.   ANNALS OF ONCOLOGY

704P Treatment patterns among patients with advanced urothelial carcinoma (aUC) in the USA

(2021) A.K. Morgans et al.   ANNALS OF ONCOLOGY

701P Real-world (RW) treatment (Tx) patterns and clinical outcomes in patients (pts) with metastatic urothelial carcinoma (mUC) receiving first-line (1L) Tx: Results from IMPACT UC

(2021) M.A. Bilen et al.   ANNALS OF ONCOLOGY

Avelumab first-line maintenance in locally advanced or metastatic urothelial carcinoma: Applying clinical trial findings to clinical practice

(2021) Petros Grivas et al.   CANCER TREATMENT REVIEWS

Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC) in the JAVELIN Bladder 100 trial: Subgroup analysis by duration of treatment-free interval (TFI) from end of chemotherapy to start of maintenance.

(2021) Srikala S. Sridhar et al.   JOURNAL OF CLINICAL ONCOLOGY

Avelumab first-line (1L) maintenance plus best supportive care (BSC) versus BSC alone for advanced urothelial carcinoma (UC): Analysis of time to end of next-line therapy in JAVELIN Bladder 100.

(2021) Petros Grivas et al.   JOURNAL OF CLINICAL ONCOLOGY

Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Analysis of clinical and genomic subgroups from the JAVELIN Bladder 100 trial.

(2021) Thomas Powles et al.   JOURNAL OF CLINICAL ONCOLOGY

Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial

(2021) Thomas Powles et al.   LANCET ONCOLOGY

Overall Survival of Patients Receiving Cisplatin or Carboplatin for Primary Metastatic Urothelial Carcinoma of the Bladder: A Contemporary Dutch Nationwide Cohort Study

(2021) Anke Richters et al.   European Urology Focus

Evidence or Prejudice? Critical Re-Analysis of Randomized Controlled Trials Comparing Overall Survival After Cisplatin Versus Carboplatin-Based Regimens in Advanced Urothelial Carcinoma

(2021) Anke Richters et al.   Clinical Genitourinary Cancer

The 2021 Updated European Association of Urology Guidelines on Metastatic Urothelial Carcinoma

(2021) Richard Cathomas et al.   EUROPEAN UROLOGY

Avelumab maintenance in advanced urothelial carcinoma: biomarker analysis of the phase 3 JAVELIN Bladder 100 trial

(2021) Thomas Powles et al.   NATURE MEDICINE

Real-world treatment patterns and clinical outcomes among patients with advanced urothelial carcinoma in the United States

(2021) Daniel M. Geynisman et al.   UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Bladder cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up

(2021) T. Powles et al.   ANNALS OF ONCOLOGY

Randomized Double-Blind Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer

(2020) Matthew D. Galsky et al.   JOURNAL OF CLINICAL ONCOLOGY

Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial

(2020) Matthew D Galsky et al.   LANCET

Patient reported symptoms associated with quality of life during chemo‐ or immunotherapy for bladder cancer patients with advanced disease

(2020) Gry A. Taarnhøj et al.   Cancer Medicine

Nivolumab in Patients with Advanced Platinum-resistant Urothelial Carcinoma: Efficacy, Safety, and Biomarker Analyses with Extended Follow-up from CheckMate 275

(2020) Matthew D. Galsky et al.   CLINICAL CANCER RESEARCH

Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial

(2020) Thomas Powles et al.   LANCET ONCOLOGY

Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma

(2020) Thomas Powles et al.   NEW ENGLAND JOURNAL OF MEDICINE

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

(2020) Andrea B Apolo et al.   Journal for ImmunoTherapy of Cancer

PCN341 Treatment Patterns and Clinical Outcomes in Patients with Locally Advanced or Metastatic Urothelial Cancer in England: Results of a Longitudinal Observational Cohort Study

(2020) M. Kearney et al.   VALUE IN HEALTH

PCN329 Utilising Public Health England Datasets to Establish a Standing Cohort of Patients with Metastatic Bladder Cancer: Initial Results and Algorithm Defining Disease Progression

(2020) F.J. Davies et al.   VALUE IN HEALTH

Randomized phase III KEYNOTE-045 trial of pembrolizumab versus paclitaxel, docetaxel, or vinflunine in recurrent advanced urothelial cancer: results of >2 years of follow-up

(2019) Y Fradet et al.   ANNALS OF ONCOLOGY

Outcomes in patients with metastatic bladder cancer in the USA: a retrospective electronic medical record study

(2019) Kyle Flannery et al.   Future Oncology

Immune Checkpoint Inhibitors as Switch or Continuation Maintenance Therapy in Solid Tumors: Rationale and Current State

(2019) Petros Grivas et al.   Targeted Oncology

The global burden of urinary bladder cancer: an update

(2019) Anke Richters et al.   WORLD JOURNAL OF UROLOGY

Population Modeling of Tumor Kinetics and Overall Survival to Identify Prognostic and Predictive Biomarkers of Efficacy for Durvalumab in Patients With Urothelial Carcinoma

(2018) Yanan Zheng et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial

(2018) Thomas Powles et al.   LANCET

A Real-World Data Study to Evaluate Treatment Patterns, Clinical Characteristics and Survival Outcomes for First- and Second-Line Treatment in Locally Advanced and Metastatic Urothelial Cancer Patients in Germany

(2018) Günter Niegisch et al.   Journal of Cancer

Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial

(2017) Robert L Coleman et al.   LANCET

Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial

(2017) Arjun V Balar et al.   LANCET

Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial

(2017) Eric Pujade-Lauraine et al.   LANCET ONCOLOGY

First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study

(2017) Arjun V Balar et al.   LANCET ONCOLOGY

Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer

(2016) Mansoor R. Mirza et al.   NEW ENGLAND JOURNAL OF MEDICINE

The Health Economics of Bladder Cancer: An Updated Review of the Published Literature

(2014) Christina Yeung et al.   PHARMACOECONOMICS

Quality of life in patients with muscle invasive and non-muscle invasive bladder cancer

(2012) S. Singer et al.   SUPPORTIVE CARE IN CANCER

Treatment of Patients With Metastatic Urothelial Cancer “Unfit” for Cisplatin-Based Chemotherapy

(2011) Matthew D. Galsky et al.   JOURNAL OF CLINICAL ONCOLOGY

Randomized Phase II/III Trial Assessing Gemcitabine/Carboplatin and Methotrexate/Carboplatin/Vinblastine in Patients With Advanced Urothelial Cancer Who Are Unfit for Cisplatin-Based Chemotherapy: EORTC Study 30986

(2011) Maria De Santis et al.   JOURNAL OF CLINICAL ONCOLOGY

Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study

(2009) Tudor Ciuleanu et al.   LANCET