The FDA approval of five immune checkpoint inhibitors for advanced or metastatic bladder cancer has significantly altered the treatment landscape, which has historically been dominated by chemotherapy regimens. However, only about 20% of patients will benefit from immune checkpoint inhibitor therapy, after which effective alternative therapies are severely limited. The FDA’s 2019 approval of Balversa (Johnson & Johnson) has provided an additional treatment option for the 15-20% of patients with susceptible FGFR alterations. However, given the dismal overall survival for patients with distant metastases, a significant level of unmet need remains in the bladder cancer drug market.

Questions Answered

  •  How important are clinical drug attributes in medical oncologists’ prescribing decisions? What are the key influencers on treatment decisions and the hidden opportunities that drug developers could leverage?
  • How do key current therapies, such as Tecentriq (Roche) and Keytruda (Merck & Co.), perform on key clinical drug attributes for this patient population? Are medical oncologists satisfied with current therapies?
  • What are the greatest unmet needs and most attractive opportunities in this patient population?
  • What trade-offs are surveyed medical oncologists willing to make across key drug attributes and price when considering a hypothetical target product profile?

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 DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 61 U.S. and 30 European medical oncologists fielded in December 2019.

Key companies:  Merck & Co., Roche / Genentech, Bristol-Myers Squibb, Merck KGaA / Pfizer, AstraZeneca, Johnson & Johnson.

Key drugs: Keytruda, Tecentriq, Opdivo, Bavencio, Imfinzi, Balversa.

Table of contents

  • Bladder Cancer - Unmet Need - Detailed, Expanded Analysis (US/EU5)
    • Executive Summary
      • Unmet Need - Bladder Cancer - Executive Summary - March 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products / 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 Oncologists’ 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 Oncologists’ 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 Agent with Improved Survival Benefit
          • Opportunity: A New Therapy with Delayed Progression-Free Survival
          • Opportunity: A Novel Therapy That Improves Tumor Response
          • Opportunity: A New Agent with an Improved Safety and Tolerability Profile
      • 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
          • Median Progression-Free Survival
          • Objective Response Rate
          • Incidence of Grade 3/4 Neutropenia
          • Incidence of Any Grade Immune-Related Adverse Events
          • Incidence of Any Grade Gastrointestinal Adverse Events
          • 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 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

    Author(s): Priti Girotra, M.Pharm., Ph.D

    Priti Girotra, M.Pharm., Ph.D., is an analyst in the oncology team at Decision Resources Group and has authored insightful content on multiple indications including Non-Small-Cell Lung Cancer, Colorectal Cancer, Gastroesophageal Cancer, Malignant Melanoma, and Multiple Myeloma. Prior to joining DRG, Dr. Girotra conducted her Ph.D. research on formulation optimization of nanoparticles containing triptan derivatives for effective brain targeting and therapeutic management of migraine, under a DST-INSPIRE Fellowship at G.J. University of Science & Technology, Hisar, India.


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