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Bladder Cancer [2017]

Bladder Cancer [2017]


How will immune checkpoint inhibitors transform the treatment of Bladder Cancer?

Significant progress has been made over the past decade in bladder cancer as a host of new targeted therapies have emerged from the development pipeline. Five PD-1/PD-L1 immune checkpoint inhibitors have been approved but how are they set to impact treatment pathways? Which checkpoint inhibitor do the key opinion leaders (KOLs) think will dominate the market and how can each one successfully differentiate itself in a fast evolving landscape? Targeted agents such as Eli Lilly’s Cyramza are also in the pipeline but what are the most important factors to ensure utilisation of these novel agents?

Learn how KOLs see the market evolving, and how they expect developers to differentiate their marketed and pipeline therapies in KOL Insight: Bladder Cancer. Twelve US and European KOLs provide their candid insights on eight marketed products and four Phase III pipeline programmes


Research Objectives

Questions Asked

See the RCC therapies covered

Find out who the 6 US and 6 European KOLs are

Top Takeaways

What unmet needs exist in non-muscle invasive bladder cancer (NMIBC) and is the BCG vaccine addressing these needs? Will the conventional Bacillus Calmette–Guérin (BCG) vaccine retain its hold as standard of care in the high-risk NMIBC setting?

Which novel intravesical therapies are likely to treat NMIBC in the future and will they be embraced? Instiladrin (FKD Therapies/Merck & Co.), Vicinium (Eleven Biotherapeutics) and ALT-803 (Altor BioScience) are all in the Phase III pipeline but how are they perceived by KOLs?

Five PD-1/PD-L1 checkpoint inhibitors have been approved for advanced bladder cancer but which ones are KOLs most enthusiastic about? Find out how the immune checkpoint inhibitors are expected to impact bladder cancer and how these agents are perceived by regulatory authorities?

How do KOLs believe the immune checkpoint inhibitors can successfully differentiate themselves? How are KOLs weighing up each checkpoint inhibitor in terms of efficacy, safety, administration and access? Find out which checkpoint inhibitor has the most opportunity in the adjuvant setting or as a maintenance approach.

Can targeted agents such as Eli Lilly’s Cyramza forge a niche in the treatment algorithm? Based on results of the RANGE study, how do KOLs view Cyramza (ramucirumab) as a potential treatment for bladder cancer? What will be critical for commercial success in this indication?

Which innovative mechanisms of action are KOLs most excited about? Angiogenesis inhibitors and fibroblast growth factor (FGF) receptor inhibitors are all in the early-stage pipeline but are there any novel mechanisms that stand out to KOLs?

How will future treatment pathways evolve for the treatment of bladder cancer? Find out if immune checkpoint inhibitors or combination therapies are expected to play an important role.


“A lot of patients will have a PD-1 inhibitor upfront. There may be a small group of patients with metastatic and more aggressive disease, who will be having [upfront] combinations of PD-1 and CTLA-4 inhibitors, or possibly IDO inhibitors.” EU Key Opinion Leader

“It has been a hugely exciting time in the last two years. Suddenly, in bladder cancer, things are taking off. It's really quite exciting.” US Key Opinion Leader

Sample of therapies covered

Marketed Therapies

Valstar (valrubicin; Endo Pharmaceuticals)

TheraCys/Immucyst (BCG vaccine; Sanofi Pasteur/Merck & Co.)

Javlor (vinflunine ditartrate; Pierre Fabre)

Tecentriq (atezolizumab; Roche)

Keytruda (pembrolizumab; Merck & Co.)

Opdivo (nivolumab; BMS)

Imfinzi (durvalumab; AstraZeneca)

Bavencio (avelumab; Merck KGaA/Pfizer)

Pipeline Therapies

Cyramza (ramucirumab; Eli Lilly)

Instiladrin (SCH 721015; FKD Therapies/Merck & Co.)

Vicinium (VB4-845; Eleven Biotherapeutics)

ALT-803 (Altor BioScience)

KOLs Interviewed

KOLs from North America

Dr. Robert Dreicer, MD; Deputy Director of University of Virginia (UVA) Cancer Center, Director of Solid Tumor Oncology within the division of Hematology/Oncology and Professor of Medicine and Urology, at the University of Virginia School of Medicine, Virginia

Dr. Donald Lamm, MD, FACP; Clinical Professor at the University of Arizona and Director of the BCG Oncology practice in Phoenix, Arizona

Dr. Arlene O Siefker-Radtke, MD; Associate Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center, Houston, Texas

Dr. Daniel Petrylak, MD; Professor of Medicine (Medical Oncology) and of Urology at Yale Cancer Center and Co-Director of the Signal Transduction Research Program, Yale University, New Haven, Connecticut

Dr. David I. Quinn MBBS, PhD, FRACP FACP; Medical Director of the Norris Cancer Hospital and Clinics, Head of the Section of Genitourinary Medical Oncology and Associate Professor of Medicine in the Division of Cancer Medicine and Blood Diseases at the Keck School of Medicine of the University of Southern California (USC), California

Anonymous, US KOL; Professor of Medicine at a leading Oncology Institute

KOLs from Europe

Professor Robert Huddart MA (Oxon), MBBS, MRCP, FRCR, PhD; Leader of the Clinical Academic Radiotherapy team at the Institute of Cancer Research (ICR) in London, UK

Professor Dr. Theo M de Reijke, MD, PhD, FEBU; Professor of Urology at the Academic Medical Center (AMC), Amsterdam, Netherlands

Professor Robert Jones, MBChB, PhD; Professor of Clinical Cancer Research (Clinical Trials Research) and Consultant in Medical Oncology at the University of Glasgow, UK

Professor Morgan Roupret, MD, PhD; Academic Professor of Urology, Hopital Pitié-Salpétrière at the University of Paris, France

Professor Dr. Shahrokh F. Shariat, MD; Professor and Chairman of the Department of Urology at the Medical University of Vienna, Austria

Anonymous, German KOL; Professor of Urology at a leading German Institute

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1. Executive summary
2. Research objectives
3. Research focus
4. Market overview
4.1 Current treatments for NMIBC
4.1.1 BCG vaccine (Sanofi Pasteur/Merck & Co) and Valstar (valrubicin; Endo Pharmaceuticals)
4.2 Current treatments for MIBC
4.2.1 Javlor (vinflunine ditartrate; Pierre Fabre)
4.3 Current and Future treatment with Immune Checkpoint Inhibitors
4.4 Overview
4.5 Marketed drugs
4.5.1 Tecentriq (atezolizumab; Roche)
4.5.2 Keytruda (pembrolizumab; Merck & Co)
4.5.3 Opdivo (nivolumab; BMS)
4.5.4 Imfinzi (durvalumab; AstraZeneca)
4.5.5 Bavencio (avelumab; Merck KGaA/Pfizer)
5. Late Stage Development Pipeline 80
5.1 Overview
5.1.1 Angiogenesis Inhibitors
5.1.2 Cyramza (ramucirumab; Eli Lilly)
5.1.3 Other immunomodulators/gene therapies
5.1.4 Instiladrin (SCH 721015; FKD Therapies/Merck & Co.)
5.1.5 Vicinium (VB4-845; Eleven Biotherapeutics)
5.1.6 ALT-803 (Altor BioScience)
6. Innovative Early Stage Development
6.1 Overview
6.1.1 Key insights summary
6.1.2 FGF receptor inhibitors
7. Current and Future Treatment Algorithm
7.1 Future Treatment Paradigm – Muscle Invasive Bladder Cancer
7.1.2 Key insights summary for MIBC
7.2 Future Treatment Paradigm – Non-muscle Invasive Bladder Cancer
7.2.1 Key insights summary for NMIBC
8 Appendix
8.1 KOL details
8.1.1 KOLs from North America
8.1.2 KOLs from the EU

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