Bladder Cancer And Upper Tract Urothelial Carcinoma – Unmet Need – Detailed, Expanded Analysis: Unresectable Locally Advanced Or Metastatic Bladder Cancer (US/EU)
The approvals of anti-PD-1/PD-L1 therapies—Keytruda (Merck & Co.), Opdivo (Bristol Myers Squibb), and Bavencio (Merck KGaA)—and antibody-drug conjugates—Padcev (Seagen / Astellas) and Trodelvy (Gilead)—have greatly altered the treatment landscape for bladder cancer in the last few years and markedly diversified the treatment armamentarium for locally advanced and metastatic disease. The approval of Balversa (Janssen Biotech) in the United States has provided an additional treatment option for the 15-20% of patients with susceptible FGFR alterations. However, given the dismal overall survival of patients with distant metastases and the lack of effective treatments for all patients, a significant level of unmet need remains in this indication.
QUESTIONS ANSWERED
- How important are clinical drug attributes in medical oncologists’ prescribing decisions? What are the key influences on treatment decisions and the hidden opportunities that drug developers could leverage? What are the treatment drivers and goals in unresectable locally advanced or metastatic bladder cancer?
- How do key current therapies, such as Keytruda, Bavencio, Opdivo, and Padcev, perform on key clinical drug attributes in this patient population? How satisfied are medical oncologists with current therapies?
- What are the greatest unmet needs and most attractive opportunities in this patient population?
- What trade-offs across different clinical attributes and price are acceptable to U.S. and European medical oncologists for a hypothetical new drug for unresectable locally advanced or metastatic bladder cancer?
PRODUCT DESCRIPTION
Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. One market scenario is profiled in detail by Clarivate experts, and additional customized market scenarios can be evaluated with the corresponding TPP Simulator.
Markets covered: United States, France, Germany, United Kingdom
Primary research: Survey of 61 U.S. and 30 European medical oncologists fielded in January 2023
Key companies: Merck & Co., Bristol Myers Squibb, Merck KGaA, Janssen Biotech, Seagen, Astellas, Gilead
Key drugs: Keytruda, Opdivo, Bavencio, Balversa, Padcev, Trodelvy
Table of contents
- Bladder Cancer And Upper Tract Urothelial Carcinoma - Unmet Need - Detailed, Expanded Analysis: Unresectable Locally Advanced Or Metastatic Bladder Cancer (US/EU)
- Executive summary
- Unmet Need - Unresectable locally advanced or metastatic bladder cancer - Executive summary - May 2023
- Introduction
- Overview
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for treatment drivers and goals
- Rationale for drug selection
- Regimens for unresectable locally advanced or metastatic bladder cancer and rationale for drug selection
- Treatment drivers and goals
- Key findings: attribute importance
- Relative importance of efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to surveyed medical oncologists' prescribing decisions in unresectable locally advanced or metastatic bladder cancer
- Importance of efficacy attributes to prescribing decisions in unresectable locally advanced or metastatic bladder cancer: United States
- Importance of efficacy attributes to prescribing decisions in unresectable locally advanced or metastatic bladder cancer: Europe
- Importance of safety and tolerability attributes to prescribing decisions in unresectable locally advanced or metastatic bladder cancer: United States
- Importance of safety and tolerability attributes to prescribing decisions in unresectable locally advanced or metastatic bladder cancer: Europe
- Importance of convenience of administration attributes to prescribing decisions in unresectable locally advanced or metastatic bladder cancer: United States
- Importance of convenience of administration attributes to prescribing decisions in unresectable locally advanced or metastatic bladder cancer: Europe
- Key findings: stated vs. derived importance
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in unresectable locally advanced or metastatic bladder cancer: United States
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in unresectable locally advanced or metastatic bladder cancer: Europe
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for unresectable locally advanced or metastatic bladder cancer: United States
- Overall performance of key therapies for unresectable locally advanced or metastatic bladder cancer: Europe
- Mean overall performance of key therapies for unresectable locally advanced or metastatic bladder cancer: United States and Europe
- Relative performance of key therapies for unresectable locally advanced or metastatic bladder cancer across select efficacy attributes: United States
- Relative performance of key therapies for unresectable locally advanced or metastatic bladder cancer across select efficacy attributes: Europe
- Relative performance of key therapies for unresectable locally advanced or metastatic bladder cancer across select safety and tolerability attributes: United States
- Relative performance of key therapies for unresectable locally advanced or metastatic bladder cancer across select safety and tolerability attributes: Europe
- Relative performance of key therapies for unresectable locally advanced or metastatic bladder cancer across select convenience of administration attributes: United States
- Relative performance of key therapies for unresectable locally advanced or metastatic bladder cancer across select convenience of administration attributes: Europe
- Assessment of unmet need
- Key findings: unmet need in unresectable locally advanced or metastatic bladder cancer
- Surveyed medical oncologistsu2019 satisfaction with the performance of key therapies for unresectable locally advanced or metastatic bladder cancer on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed medical oncologistsu2019 satisfaction with the performance of key therapies for unresectable locally advanced or metastatic bladder cancer on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed medical oncologists' ascribed level of unmet need across key efficacy attributes in unresectable locally advanced or metastatic bladder cancer: United States
- Surveyed medical oncologists' ascribed level of unmet need across key efficacy attributes in unresectable locally advanced or metastatic bladder cancer: Europe
- Surveyed medical oncologists' ascribed level of unmet need across key safety and tolerability attributes in unresectable locally advanced or metastatic bladder cancer: United States
- Surveyed medical oncologists' ascribed level of unmet need across key safety and tolerability attributes in unresectable locally advanced or metastatic bladder cancer: Europe
- Surveyed medical oncologists' ascribed level of unmet need across key convenience of administration attributes in unresectable locally advanced or metastatic bladder cancer: United States
- Surveyed medical oncologists' ascribed level of unmet need across key convenience of administration attributes in unresectable locally advanced or metastatic bladder cancer: Europe
- Key findings: unmet need in unresectable locally advanced or metastatic bladder cancer and related indications
- Surveyed medical oncologists' ascribed level of unmet need in unresectable locally advanced or metastatic bladder cancer and related indications: United States
- Surveyed medical oncologists' ascribed level of unmet need in unresectable locally advanced or metastatic bladder cancer and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the unresectable locally advanced or metastatic bladder cancer market and emerging therapy insights
- Opportunity: a novel therapy with improved survival benefit
- Opportunity: a novel therapy that improves progression-free survival
- Opportunity: a novel therapy that improves tumor response
- Opportunity: a novel therapy with improved safety and tolerability
- Areas of opportunity in the unresectable locally advanced or metastatic bladder cancer market and emerging therapy insights
- Target product profiles
- Assessing drug development opportunities
- Target product profile methodology
- Attributes and attribute levels
- Assigned prohibitions for the conjoint module
- Attribute importance and part-worth utilities
- First-line unresectable locally advanced or metastatic bladder cancer target product profile: attribute importance
- Median overall survival (months)
- Median progression-free survival (months)
- Objective response rate (% of patients)
- Incidence of grade 3/4 neutropenia (% of patients)
- Incidence of any grade immune-related adverse events (% of patients)
- Incidence of any grade peripheral neuropathy (% of patients)
- Price per 21-day cycle
- Conjoint analysis-based simulation of a market scenario
- First-line unresectable locally advanced or metastatic bladder cancer market simulation: share of preference of target product profiles included in the market scenario
- First-line unresectable locally advanced or metastatic bladder cancer market simulation: likelihood to prescribe of target product profiles included in the market scenario
- First-line unresectable locally advanced or metastatic bladder cancer market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive summary
Saurabh Virdi, B.Tech., Lead Healthcare Research & Data Analyst, Oncology. Mr. Virdi has more than seven years working in the pharmaceutical industry providing analytical support in various therapy areas, including oncology, HIV, vaccines, specialty pharma, and rare diseases. Prior to joining Clarivate, he was an assistant project manager at DelveInsight Business Research LLP, where he was responsible for developing and delivering customized market and asset value forecasts. Before DelveInsight, he worked at WNS GSK Knowledge center and SmartAnalyst, where, as part of multifunctional teams, he helped clients’ decision making throughout the development journey from early-stage to marketed drugs. He obtained his bachelor’s degree in biotechnology from Delhi Technological University in India.
Catherine E. Willoughby, Ph.D., Healthcare Research & Data Analyst, Oncology. Dr. Willoughby has more than 10 years of experience in oncology research and drug discovery. She obtained her Ph.D. at Newcastle University, where she explored novel therapeutic strategies to treat liver cancer. She was a Sara Borrell Postdoctoral Fellow at IDIBAPS-Hospital Clinic, where she investigated new treatment combinations to overcome resistance to immune checkpoint inhibitors, and more recently a postdoctoral fellow at IRB Barcelona, where she investigated molecular glue therapeutics to treat immune-inflammatory skin diseases. Dr. Willoughby also holds a B.Sc. (Honors) in medical biochemistry with industrial experience from the University of Manchester and an M.Res. in cancer research from Newcastle University.