Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Every year, thousands of lives are affected by urothelial cancer (UC), the most common type of bladder cancer (BC), which affects the bladder, and other parts of the urinary system. In the United Kingdom (UK), BC, accounts for 3% of all newly diagnosed cancer cases annually (1). World Cancer Research Fund (WCRF) reports ~23,600 new cases diagnosed in the UK in 2022, with ~30% of these dying from the disease (2) . Bladder cancer is a disease of significant public health concern, with higher incidence in males, patients >75 years, a history of cigarette smoking, those with a family history of cancer and previous exposure to industrial chemicals (3). BC can be classified into 2 main types: non-muscle invasive bladder cancer (NMIBC) and muscle-invasive BC (MIBC) (4). NMIBC refers to diagnosis at an early stage when the cancer is confined to the inner lining of the bladder and MIBC typically involves a spread outside of the inner lining of the bladder. Survival rates for BC vary significantly depending on stage at diagnosis. Patients diagnosed at early stages are more likely to survive, as metastatic disease is usually associated with poor prognosis in patients. One year survival for stages I, II, III and IV are 95.2%, 75%, 64.4% and 29.2% respectively, with early-stage BC offering the best opportunities for effective treatment and improved long-term outcomes (3). Conducting research in BC is crucial to improve treatment, survival rates and quality of life in these patients.
On February 4th, 2025, in commemoration of World Cancer Day, we reflect on the evolution of the treatment landscape for urothelial cancer over the past few decades. Several modalities of treatment including surgery, chemotherapy, radiotherapy, and immunotherapy have all been used as treatment options for BC. Among these, platinum-based chemotherapy (PBC), typically using cisplatin or carboplatin in combination with gemcitabine remains a cornerstone of treatment. Cisplatin-based chemotherapy, with gemcitabine, has long been the standard of care for locally advanced or metastatic BC in the first line (1L). However, in patients who experience severe side effects or limited efficacy, carboplatin-based chemotherapy also combined with gemcitabine is offered as an alternative, owing to its lower toxicity profile and the recommendation for its use in patients not eligible for cisplatin. Second line (2L) treatment is usually dependent on prior treatment and can include further PBC, taxanes (e.g. paclitaxel, or docetaxel), or best supportive care (BSC) (4,5). In patients who do not experience disease progression following 1L PBC, the introduction of immunotherapy as 1L maintenance therapy has shown promising results in extending survival.
This blog post highlights previous evidence from randomised controlled trials (RCTs) and the use of real-world evidence (RWE) to understand the current BC treatment landscape and spotlights avelumab (also known as Bavencio) which is an innovative immune checkpoint inhibitor used in treating locally advanced or metastatic urothelial cancer. Avelumab, a humanised recombinant immunoglobulin G1 (IgG1) antibody, acts by targeting and blocking PD-L1 (programmed death-ligand 1) protein which plays a vital role in the ability of cancer cells to evade the immune system (6). Traditionally, chemotherapy was the cornerstone of treatment until the introduction of newer immunotherapies such as avelumab. The groundbreaking JAVELIN Bladder 100 clinical trial provided valuable insights into the efficacy of avelumab for advanced urothelial cancer. The JAVELIN Bladder 100 trial was a randomised, multi-centre open label study aimed at assessing the efficacy of avelumab as maintenance therapy in patients who had received 1L PBC (7). The study followed up patients for >2 years and showed improved overall survival (OS), 23.8 months (95% CI, 19.9 to 28.8) in the avelumab group compared to patients on best supportive care (BSC), where it was 15.0 months (95% CI, 13.5 to 18.2). Similarly, median progression-free survival (mPFS) was 5.5 months (95% CI, 4.2 to 7.2) in the avelumab group compared to 2.1 months (95% CI, 1.9 to 3.0) in the BSC group (7). The findings from this trial were pivotal in reshaping recommendations for the treatment of advanced or metastatic BC (8).
A major milestone was achieved in June 2020, when avelumab was approved by the US Food and Drug Administration (FDA) as maintenance therapy in patients with locally advanced or metastatic BC (9). From September 2020, avelumab became available to UK patients via an Early Access to Medicines Scheme (EAMS) providing patients access to avelumab before it was formally licensed in the UK. In January 2021, the European Commission approved avelumab as a monotherapy for the 1L maintenance of locally advanced or metastatic BC who were progression free following PBC (10). Subsequently, on April 7th, 2022, the National Institute for Health and Care Excellence (NICE), recommended avelumab as standard of care for first line (1L) maintenance therapy in patients who had complete or partial response, or stable disease after completing 1L PBC in the UK, highlighting its effectiveness in improving patient outcomes (11).
A UK real-world study which included 106 adult patients diagnosed with locally advanced or metastatic UC who demonstrated at least stable disease following 1L PBC and were prescribed avelumab from October 2020 as part of EAMS, assessed real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) in these patients. Interim analysis showed that 57.5% of patients (95% CI 48.8-67.7) were alive 12 months after avelumab initiation. 42.3% of patients (95% CI 33.9-52.9) were alive and progression free at 12 months; median rwPFS was 8.7 months (95% CI 7.1 -Not estimable (NE)). Median avelumab treatment duration was 30.7 weeks. These early results suggest clinical effectiveness in UK patients with advanced UC and are comparable to other real-world data, such as in the AVENANCE (12) study. These findings were presented at the European Multidisciplinary Congress on Urological Cancers in 2023 (EMUC2023) (13). Updated results from this study will be presented at the ASCO- Genitourinary Cancers Conference (ASCO-GU) in February 2025.
IQVIA has played a critical role in advancing real-world evidence and generating valuable insights into the effectiveness of specific therapies for BC, in the real-world setting. Through IQVIA’s robust primary data collection studies in various sites across the United Kingdom, and deep scientific expertise in oncology, it has contributed to the understanding of outcomes in patients with locally advanced or metastatic BC. Going beyond clinical trials, IQVIA generates real-world evidence, to support improvements in patient care and outcomes. As discussed in another IQVIA publication (14), integrated evidence comprising data from randomised clinical trials and real-world evidence is one of the strategic pillars for achieving launch excellence in oncology and to enable the effective adoption of innovative therapies in eligible patient populations.
1 Cancer Research UK. Bladder Cancer Statistics https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer.
2 World Cancer Research Fund Bladder Cancer Statistics https://www.wcrf.org/preventing-cancer/cancer-statistics/bladder-cancer-statistics/.
3 Jones RJ, Crabb SJ, Linch M, Birtle AJ, McGrane J, Enting D, et al. Systemic anticancer therapy for urothelial carcinoma: UK oncologists’ perspective. Br J Cancer. 2024 Apr 6;130(6):897–907.
4 National Institute for Health and Care Excellence (NICE). Bladder cancer: diagnosis and management | Guidance | 2015 25 February 2015; Available from: https://www.nice.org.uk/guidance/ng2/chapter/Recommendations.
5 Rani, B., et al.,. Current and Emerging Strategies to Treat Urothelial Carcinoma. Cancers (Basel), 2023. 15(19).
6 Collins JM, Gulley JL. Product review: avelumab, an anti-PD-L1 antibody. Human Vaccines & Immunotherapeutics. 2019 Apr 3;15(4):891–908.
7 Powles T, Park SH, Caserta C, Valderrama BP, Gurney H, Ullén A, et al. Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After ≥2 Years of Follow-Up. JCO. 2023 Jul 1;41(19):3486–92.
8 Grivas P, Grande E, Davis ID, Moon HH, Grimm MO, Gupta S, et al. Avelumab first-line maintenance treatment for advanced urothelial carcinoma: review of evidence to guide clinical practice. ESMO Open. 2023 Dec;8(6):102050.
9 US Food and Drug Administration (US FDA). FDA approves avelumab for urothelial carcinoma maintenance treatment. 2020 07 January; [Internet]. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-avelumab-urothelial-carcinoma-maintenance-treatment.
10 Merck. European Commission Approves BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma. 2021 25 January 2021 [Internet]. [cited 2025 Jan 22]. Available from: https://www.merckgroup.com/en/news/bavencio-1l-uc-eu-approval-25-01-2021.html
11 National Institute of Health and Care Excellence (NICE) Avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy [Internet]. 2022 May. Available from: https://www.nice.org.uk/guidance/ta788/chapter/1-Recommendations
12 Barthélémy P, Thibault C, Fléchon A, Gross-Goupil M, Voog E, Eymard JC, et al. Real-world Study of Avelumab First-line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma in France: Overall Results from the Noninterventional AVENANCE Study and Analysis of Outcomes by Second-line Treatment. European Urology Oncology. 2024 Oct;S2588931124002232.
13 Jones R.J, Shah Y., Birtle A, Challapalli A, Chan J, Enting D, et al. P236: Avelumab first-line (1L) maintenance therapy for advanced urothelial cancer: Real-world early clinical experience in the UK. In. Available from: https://urosource.uroweb.org/resource-centres/EMUC23/256109/abstract
14 Achieving Oncology Launch Excellence, IQVIA White Paper, 2024: https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/iqvia-oncology-launch-excellence-07-2024.pdf.
IQVIA Real World Solutions is the proven partner life science companies trust to take on their complex evidence challenges. We enable our customers to generate and disseminate real world evidence to answer crucial questions and meet the needs of their stakeholders.
