Hepatocellular carcinoma, the most common type of primary liver cancer, occurs as a results of chronic liver cirrhosis and has a five-year survival rate of only 18%. First-line advanced hepatocellular carcinoma is the largest drug-treatable hepatocellular carcinoma population and thus is commercially lucrative for drug developers. This setting is dominated by targeted therapies such as Nexavar (Bayer HealthCare / Amgen / Onyx), Lenvima (Eisai / Merck & Co.), Stivarga (Bayer HealthCare), Cabometyx (Exelixis), and Cyramza (Eli Lilly) as well as immunotherapies such as Opdivo (Bristol Myers Squibb / Ono Pharmaceuticals) and Keytruda (Merck & Co.). We estimate that the hepatocellular carcinoma market will grow rapidly, fueled by immune checkpoint inhibitors and uptake of multiple combination regimens. This report presents a detailed analysis of the goals of advanced hepatocellular carcinoma treatment and reviews the unmet needs that novel therapies should address.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals for advanced hepatocellular carcinoma? What are the key influencers of treatment decisions and the hidden opportunities that developers could leverage?
  • What are the prevailing areas of unmet need and opportunity in advanced hepatocellular carcinoma?
  • How do immune checkpoint inhibitors such as Merck’s Keytruda and Bristol Myers Squibb’s Opdivo perform on key clinical drug attributes for this patient population?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European oncologists for a new treatment for advanced hepatocellular carcinoma?

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 60 U.S. and 30 European medical oncologists fielded in April 2020.

Key companies: Merck, Bristol Myers Squibb, Eisai, Exelixis, Bayer / Onyx Pharmaceuticals.

Key drugs: Nexavar, Lenvima, Stivarga, Cabometyx, Cyramza, Keytruda, Opdivo.

Table of contents

  • Hepatocellular Carcinoma - Unmet Need - Detailed, Expanded Analysis - Advanced Hepatocellular Carcinoma (US/EU5)
    • Executive Summary
      • Unmet Need - Advanced Hepatocellular Carcinoma - Executive Summary - August 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products for Advanced Hepatocellular Carcinoma 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 Advanced Hepatocellular Carcinoma
        • Importance of Efficacy Attributes to Prescribing Decisions in Advanced Hepatocellular Carcinoma: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Advanced Hepatocellular Carcinoma: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Advanced Hepatocellular Carcinoma: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Advanced Hepatocellular Carcinoma: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Advanced Hepatocellular Carcinoma: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Advanced Hepatocellular Carcinoma: 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 Advanced Hepatocellular Carcinoma: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Advanced Hepatocellular Carcinoma: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Advanced Hepatocellular Carcinoma: United States
        • Overall Performance of Key Therapies for Advanced Hepatocellular Carcinoma: Europe
        • Mean Overall Performance of Key Therapies for Advanced Hepatocellular Carcinoma: United States and Europe
        • Relative Performance of Key Therapies for Advanced Hepatocellular Carcinoma Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Advanced Hepatocellular Carcinoma Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Advanced Hepatocellular Carcinoma Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Advanced Hepatocellular Carcinoma Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Advanced Hepatocellular Carcinoma Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Advanced Hepatocellular Carcinoma Across Select Convenience of Administration Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Advanced Hepatocellular Carcinoma
        • Surveyed Medical Oncologists' Satisfaction with the Performance of Key Therapies for Advanced Hepatocellular Carcinoma on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Medical Oncologists' Satisfaction with the Performance of Key Therapies for Advanced Hepatocellular Carcinoma 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 Advanced Hepatocellular Carcinoma: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Advanced Hepatocellular Carcinoma: Europe
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Advanced Hepatocellular Carcinoma: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Advanced Hepatocellular Carcinoma: Europe
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Advanced Hepatocellular Carcinoma: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Advanced Hepatocellular Carcinoma: Europe
        • Key Findings: Unmet Need in Advanced Hepatocellular Carcinoma and Related Indications
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need in Advanced Hepatocellular Carcinoma and Related Indications: United States
        • Surveyed Medical Oncologists' Ascribed Level of Unmet Need in Advanced Hepatocellular Carcinoma and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Advanced Hepatocellular Carcinoma Market and Emerging Therapy Insights
          • Opportunity: A Novel Therapy That Can Extend Overall Survival
          • Opportunity: A Novel Therapy That Can Improve Progression-Free Survival
          • Opportunity: A Novel Therapy 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
          • Advanced Hepatocellular Carcinoma Target Product Profile: Attribute Importance
          • Median Overall Survival
          • Median Progression-Free Survival
          • Objective response rate
          • Incidence of Grade 3/4 Diarrhea
          • Incidence of Any Grade Immune-Related Adverse Events
          • Incidence of Grade 3/4 Hand-Foot Skin Reaction
          • Price Per 28-Day Cycle
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Advanced Hepatocellular Carcinoma Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Advanced Hepatocellular Carcinoma Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Advanced Hepatocellular Carcinoma Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Bibliography

    Author(s): Ananya Sadhu, Ph.D

    Ananya Sadhu, Ph.D., is an analyst with the oncology team at Decision Resources Group with expertise in multiple oncology indications including pancreatic cancer.

    Prior to joining Decision Resources Group, Dr. Ananya Sadhu was a postdoctoral fellow at National Centre of Biological Sciences, Bangalore, where she studied the role of chromatin architecture in regulating gene expression in breast cancer. Ananya holds a Ph.D. in Molecular Biology from National Institute of Immunology, New Delhi. She also worked as a Scientific Officer with Arvind Remedies Ltd., a pharmaceutical company, where she coordinated various stages of non-clinical / clinical research activities for drug development of a U.S. patented polyherbal formulation.


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