How can immune checkpoint inhibitors differentiate themselves in the competitive Bladder cancer space?

Five PD-1/PD-L1 immune checkpoint inhibitors are approved for bladder cancer, but how are these therapies faring on the market? Find out how KOLs differentiate between the checkpoint inhibitors in this competitive and fast-evolving landscape and how they view the multitude of ongoing combination studies. Which checkpoint inhibitor do the KOLs think will dominate the market? A host of new targeted therapies are also in the pipeline including anti-VEGFR therapies (Eli Lilly’s Cyramza), FGFR inhibitors (Janssen/Astex’s erdafitinib, Bayer’s rogaratinib) and antibody-drug conjugates (Astellas/Seattle Genetics’ enfortumab vedotin). How will they impact future treatment pathways? What are the most important factors to ensure the successful uptake of other novel agents according to the experts?

Learn how KOLs see the market evolving, and how developers could differentiate their marketed and pipeline therapies in KOL Insight: Bladder Cancer. Twelve US and European KOLs provide their candid insights on eight marketed products, 12 Phase III pipeline programmes and early-stage mechanisms

• How can the unmet needs in non-muscle invasive bladder cancer (NMIBC) be addressed? Will the BCG vaccine retain its hold as first-line standard of care or can novel intravesical therapies (e.g. Instiladrin or Vicinium) compete in the intermediate- or high-risk patient settings?
• Five PD-1/PD-L1 checkpoint inhibitors are available for advanced bladder cancer; how do KOLs differentiate between them? KOLs weigh up the clinical efficacy, safety and dosing/administration profile of each checkpoint inhibitor and discuss their prescribing preferences.
• Will PD-L1 biomarker status define future eligibility for immune checkpoint treatment? Following the regulatory restrictions on first-line prescribing to patients with low PD-L1 expression, how is this likely to impact treatment decisions going forward?
• How do KOLs believe the use of the immune checkpoint inhibitors will evolve? Find out which checkpoint inhibitor has the most opportunity in future combinatorial approaches, in the neoadjuvant/adjuvant setting, or as a maintenance approach.
• Can targeted agents such as Eli Lilly’s Cyramza or Astellas/Seattle Genetics’ enfortumab vedotin forge a niche in the treatment algorithm? How do KOLs view the potential opportunity for the anti-VEGFR drug and the anti-Nectin-4 antibody-drug conjugate in bladder cancer?
• FGFR inhibitors make up a key segment of the Phase III pipeline; what are KOLs’ opinions on this novel biomarker-driven approach? Janssen/Astex’ erdafitinib and Bayer’s rogaratinib are both in Phase III development for patients harbouring FGFR mutations. Find out if KOLs are optimistic about these FGFR-targeting strategies.
• Which innovative mechanisms of action are KOLs most excited about? Many therapies are in the early-stage pipeline but are there any novel mechanisms of action that stand out to KOLs?
• How will future treatment pathways evolve for the treatment of bladder cancer? Find out which immune checkpoint inhibitors, combination strategies or targeted therapies are expected to play an important role and how they will be sequenced in the future.

“We're going to see a large landscape change here with the dual immune therapies, the CTLA-4, combined with PD-1/PD-L1 drugs. Then I think the question of combining chemotherapy with immune therapy upfront is one that might change things dramatically as well.”
US Key Opinion Leader

“We will see a growth in the molecular characterisation of patients and the first treatments that are going to be relevant for that are the FGFR inhibitors.”
EU Key Opinion Leader

Marketed Therapies

• Valstar (valrubicin; Endo Pharmaceuticals)
• TheraCys/Immucyst (BCG vaccine; Merck & Co.)
• Javlor (vinflunine ditartrate; Pierre Fabre)
• Tecentriq (atezolizumab; Roche)
• Keytruda (pembrolizumab; Merck & Co.)
• Opdivo (nivolumab; BMS)
• Imfinzi (durvalumab; AstraZeneca)
• Bavencio (avelumab; Merck Group/Pfizer)

Pipeline Therapies

• Yervoy (ipilimumab; BMS)
• tremelimumab (AstraZeneca)
• Cyramza (ramucirumab; Eli Lilly)
• enfortumab vedotin (Astellas/Seattle Genetics)
• erdafitinib (Janssen/Astex Pharmaceuticals)
• rogaratinib (Bayer)
• Instiladrin (SCH 721015; FKD Therapies/Ferring Pharmaceuticals/Merck & Co.)
• Vicinium (VB4-845; Sesen Bio)
• ALT-803 (Altor BioScience/NantKwest)
• epacadostat (Incyte)
• Qapzola (apaziquone; Spectrum Pharmaceuticals)
• MitoGel (UGN-101; UroGen Pharmaceuticals)
• sacituzumab govitecan (Immunomedics)
• CG0070 (Cold Genesys)

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 is a Professor of Medicine and Urology, at the University of Virginia School of Medicine, Virginia
• Dr. Noah Hahn MD; Deputy Director of the Johns Hopkins Greenberg Bladder Cancer Institute and is an Associate Professor of Medicine at the Department of Oncology and Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland
• Dr. Peter H. O'Donnell MD; Assistant Professor of Medicine in the Department of Medicine at the University of Chicago Medicine, Illinois
• 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. Arlene O Siefker-Radtke MD; Professor at the Department of Genitourinary Medical Oncology, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center, Houston, Texas
• Dr. Sandy Srinivas MD; Professor of Medicine (Oncology) at the Stanford University Medical Centre, Stanford, California

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 Robert Jones MBChB PhD; Professor of Clinical Cancer Research (Clinical Trials Research) and Consultant in Medical Oncology at the University of Glasgow, UK
• Dr. Pablo Maroto Rey MD; Head of the Urologic Oncology Unit at the Hospital de la Santa Creu i Sant Pau in Barcelona, Associate Professor of Medicine at the Autonomous University of Barcelona and Professor of the School of Nursing at the Autonomous University of Barcelona, Spain
• Professor Dr. Theo M de Reijke MD PhD FEBU; Professor of Urology at the Academic Medical Center (AMC), Amsterdam, Netherlands
• Anonymous German KOL; Professor of Urology at a leading German Institute
• Anonymous German KOL; Senior Medical Oncologist at a leading Institution or Hospital in Germany